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Low Particle Emission and Low Noise Tyres (LEON-T)

Primary Purpose

Noise Exposure, Sleep Disturbance, Sleep Hygiene

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tyre noise - continuous flow
Tyre noise - discrete events
High noise level
Moderate noise level
Low noise level
Air-filled tyres
Composite tyres
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Noise Exposure focused on measuring Neurobehavioural Performance, Polysomnography, Metabolomics

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1. live in or around the city of Gothenburg area (Sweden) Exclusion Criteria: aged <18 or >30 years; habitual sleep and wake timings more than ±1 hour different from the study sleep times (i.e. habitual sleep time should be 22:00-00:00 and habitual wake time should be 06:00-08:00); BMI>25 kg/m2; regular sleep medication use (prescribed or "over-the-counter"); poor hearing acuity (measured during screening via pure tone audiometry); diagnosed with sleep disorders; indications of sleep apnea on the STOP-BANG questionnaire; shift work; smoking, vaping, snus, or other nicotine use.

Sites / Locations

  • University of GothenburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Study 1: High level continuous flow tyre noise (A1)

Study 1: Medium level continuous flow tyre noise (B1)

Study 1: High level, discrete traffic tyre noise (A2)

Study 1: Medium level, discrete traffic tyre noise (B2)

Study 2: Medium level composite wheel tyre noise (A1)

Study 2: Low level composite wheel tyre noise (B1)

Study 2: Medium level air-filled tyre noise (A2)

Study 2: Low level air-filled tyre noise (B2)

Arm Description

Single study night with no noise exposure, to determine normal baseline sleep

Single study night in first experimental study arm, with traffic noise to determine consequences of sleep disturbance by high level, continuous flow traffic noise. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.

Single study night in first experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level, continuous flow traffic noise. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.

Single study night in first experimental study arm, with traffic noise events to determine consequences of sleep disturbance by high level traffic noise comprised of single, discrete traffic events. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.

Single study night in first experimental study arm, with traffic noise events to determine consequences of sleep disturbance by moderate level traffic noise comprised of single, discrete traffic events. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.

Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level traffic noise comprised of composite wheel types.

Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by low level traffic noise comprised of composite wheel types.

Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level traffic noise comprised of traditional air-filled wheel types.

Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by low level traffic noise comprised of traditional air-filled wheel types.

Outcomes

Primary Outcome Measures

Baseline total sleep time during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the A1 night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the A2 night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the B1 night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the B2 night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline N1 sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline N2 sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline N3 sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline rapid eye movement (REM) sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline wakefulness after sleep onset (WASO) during the Control night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A1
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A2
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B1
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B2
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline number of awakenings during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Number of awakenings during exposure to nocturnal tyre noise combination A1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Number of awakenings during exposure to nocturnal tyre noise combination A2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Number of awakenings during exposure to nocturnal tyre noise combination B1
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Number of awakenings during exposure to nocturnal tyre noise combination B2
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline sleep onset latency (SOL) during the Control night
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A1
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A2
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B1
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B2
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Baseline sleep efficiency during the Control night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep efficiency during exposure to nocturnal tyre noise combination A1
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep efficiency during exposure to nocturnal tyre noise combination A2
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep efficiency during exposure to nocturnal tyre noise combination B1
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Sleep efficiency during exposure to nocturnal tyre noise combination B2
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Baseline sleep depth assessed using the odds ratio product (ORP) during the Control night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A1
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A2
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B1
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B2
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Spontaneous maximal change of odds ratio product (ORP) during the Control night
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over 120 sham noise events during the night.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A1
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A2
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B1
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B2
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Morning neurobehavioural speed in the morning immediately after the Control night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Morning neurobehavioural speed in the morning immediately after the A1 night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Morning neurobehavioural speed in the morning immediately after the A2 night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Morning neurobehavioural speed in the morning immediately after the B1 night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Morning neurobehavioural speed in the morning immediately after the B2 night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Morning neurobehavioural accuracy in the morning after the control night
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A1
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A2
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B1
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B2
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Baseline evening neurobehavioural speed following the Control night
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A1
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A2
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B1
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B2
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Baseline evening neurobehavioural accuracy following the Control night
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A1
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A2
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B1
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B2
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Event-related Cardiovascular activation in response to noise during Control night
Change in heart rate (ECG)
Event-related Cardiovascular activation in response to noise during A1
Change in heart rate (ECG)
Event-related Cardiovascular activation in response to noise during A2
Change in heart rate (ECG)
Event-related Cardiovascular activation in response to noise during B1
Change in heart rate (ECG)
Event-related Cardiovascular activation in response to noise during B2
Change in heart rate (ECG)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the control night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A1 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A2 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B1 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B2 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the control night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A1 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A2 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B1 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B2 night
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Taurine concentration (mmol/L) immediately after the Control night
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Leucine concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Valine concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Phenylalanine concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L)In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Basline Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma
Baseline Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Control night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Determined from GC-MS analysis of blood plasma

Secondary Outcome Measures

Full Information

First Posted
September 23, 2022
Last Updated
February 21, 2023
Sponsor
Göteborg University
Collaborators
University of Pennsylvania, University of Manitoba, Swedish National Road and Transport Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05611619
Brief Title
Low Particle Emission and Low Noise Tyres
Acronym
LEON-T
Official Title
Low Particle Emission and Low Noise Tyres
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
University of Pennsylvania, University of Manitoba, Swedish National Road and Transport Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will investigate the biological mechanisms linking sleep disruption by noise and the development of disease. In a laboratory sleep study, the investigators will play synthesised automotive tyre sounds, investigating how acoustical characteristics of tyre noise impact on sleep macrostructure, cardiometabolic profile and cognitive performance (continuous traffic flow or a few individual, but higher level, traffic pass-bys). The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analysed to identify metabolic changes in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which chronic noise exposure at night can lead to the development of diseases in the long term, especially cardiometabolic disorders.
Detailed Description
The experimental sleep study has the overarching goal of deepening our understanding of sleep disruption by automotive tyre noise and changes in cardiometabolic and cognitive function. To this end, the study will address the following independent aims: Aim 1: Determine the biological and neurobehavioural consequences of sleep disruption by tyre noise. The investigators will measure the sleep of healthy volunteers, and each morning the investigators will obtain blood samples for metabolomics analysis and administer a neurocognitive test battery. The investigators will compare effects on sleep, metabolomics and cognitive function between quiet nights and nights with road traffic noise. Aim 2: Identify acoustical characteristics of tyre noise that are especially disturbing physiologically. The investigators will use different combinations of types of tyre noise in different noise exposure nights to determine differential effects on sleep and cardiovascular response. This study will take place in the sound environment laboratory (SEL) at the University of Gothenburg Department of Occupational and Environmental Medicine (Arbets- och miljömedicin [AMM]). The SEL is a high fidelity research laboratory equipped to simulate a typical apartment, including three individually light-, sound- and vibration-isolated private bedrooms. Ceiling mounted speakers in each room allow the investigators to create a realistic acoustic environment by transmitting sound exposures from the control room to each bedroom individually. The investigators have shown previously that results from this lab with high ecological validity are comparable with results from the field. There will be two study arms, each one affording the opportunity to investigate different acoustical characteristics of tyre noise and their physiological effects. Each of these study arms has a prospective within-subjects cross-over design. Participants (study 1 N=15; study 2 N=30; total N=45 across both arms) will each spend six consecutive nights in the SEL, with a sleep opportunity between 23:00-07:00. Daytime sleep will be prohibited, confirmed with measures of daytime activity via wrist actigraphy monitors worn continuously throughout the study. Three subjects will take part concurrently, in separate bedrooms. The first night is a habituation period to the study protocol and for familiarisation with the test procedures. Study nights 2-6 are the experimental nights and will be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to each of the following: One quiet night: No noise will be played, serving as a control night to assess individual baseline sleep, cardiometabolic profile, and cognitive performance; Four traffic noise nights: Tyre noise from road traffic noise be played into the rooms to determine the effects of noise on sleep, cardiometabolic function and cognitive performance. These noise nights will be in a 2×2 factorial design so that the investigators can examine each combination of two specific noise characteristics. Each night the investigators will record physiologic sleep with polysomnography (PSG) and cardiac activity with electrocardiography (ECG). Each study morning, subjects will provide a 4 ml blood sample, complete cognitive testing and answer questionnaires and will depart the SEL to follow their normal daytime routine. They will return to the SEL at 20:00 each evening to prepare for sleep measurements. Caffeine will be prohibited after 15:00 and alcohol will be prohibited at all times. Because extreme and/or variable dietary behaviour can affect the metabolome/lipoprotein profile, participants will be given guidance that they should eat a similar evening meal on each day of the laboratory study, confirmed with a food diary, The actual meal itself can be different for different study participants, because the study has a within-subjects design. Sleep will be recorded with ambulatory polysomnography (PSG) and cardiac activity with electrocardiography (ECG) and finger pulse photoplethysmogram. Data are recorded offline onto the sleep recorder, and will be downloaded and checked every study morning to ensure data quality. In addition to traditional sleep analysis performed by the research group at the University of Gothenburg, raw PSG data will be used to calculate the Odds Ratio Project, a novel metric of sleep depth and stability. Each study morning subjects will provide a 4 ml blood sample for plasma metabolomics analysis. To ensure reliable data, blood samples will be taken at the same time every day to mitigate circadian effects, before eating or drinking anything except water, and each sample will be handled in the same way i.e. centrifuged, aliquoted and stored in -80C freezers. Subjects will eat the same food each study evening to mitigate within-subject dietary effects on the blood metabolome. Each morning, subjects will complete a computerised cognitive test battery taking approximately 20 minutes, that includes 10 tests across a range of cognitive domains (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance). Cognition data will be analysed to determine key measures of cognitive speed and accuracy, adjusting for practice effects and the difficulty of the stimulus set. Subjects will complete a battery of one-time validated questionnaires to measure their general health (SF-36), chronotype, noise sensitivity, habitual sleep quality, environmental sensitivity, and annoyance and sleep disturbance by noise. Subjects will also answer a questionnaire each study evening and morning, involving questions on sleepiness (Karolinska Sleepiness Scale), sleep disturbance by noise, positive and negative affect (PANAS), and validated sleep and disturbance questions. Participants will wear a wrist actigraphy monitor continuously throughout the study period, and also for the week before the study, to confirm habitual sleep-wake times and to measure physical activity levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noise Exposure, Sleep Disturbance, Sleep Hygiene, Metabolic Disturbance, Cognitive Change
Keywords
Neurobehavioural Performance, Polysomnography, Metabolomics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
There will be two separate study periods, each one affording the opportunity to investigate different acoustical characteristics of tyre noise and their physiological effects. Each of these study arms has a prospective within-subjects cross-over design. The order of the noise exposure conditions will be be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to one night of each of the following: One quiet night: No noise will be played, serving as a control night to assess individual baseline sleep, cardiometabolic profile, and cognitive performance; Four traffic noise nights: Tyre noise from road traffic noise be played into the rooms to determine the effects of noise on sleep, cardiometabolic function and cognitive performance. These noise nights will be in a 2×2 factorial design so that we can examine each combination of two specific noise characteristics.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will be aware that in any given study night they can be exposed to traffic noise. They will not be informed what noise condition will occur in any given night, but they can become unblinded to the exposure if they are awake, as they will hear the noise. Study investigators responsible for analysing cognitive performance variables and physiological sleep data will be be blind to which noise interventions were introduced on which study nights.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Single study night with no noise exposure, to determine normal baseline sleep
Arm Title
Study 1: High level continuous flow tyre noise (A1)
Arm Type
Experimental
Arm Description
Single study night in first experimental study arm, with traffic noise to determine consequences of sleep disturbance by high level, continuous flow traffic noise. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.
Arm Title
Study 1: Medium level continuous flow tyre noise (B1)
Arm Type
Experimental
Arm Description
Single study night in first experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level, continuous flow traffic noise. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.
Arm Title
Study 1: High level, discrete traffic tyre noise (A2)
Arm Type
Experimental
Arm Description
Single study night in first experimental study arm, with traffic noise events to determine consequences of sleep disturbance by high level traffic noise comprised of single, discrete traffic events. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.
Arm Title
Study 1: Medium level, discrete traffic tyre noise (B2)
Arm Type
Experimental
Arm Description
Single study night in first experimental study arm, with traffic noise events to determine consequences of sleep disturbance by moderate level traffic noise comprised of single, discrete traffic events. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.
Arm Title
Study 2: Medium level composite wheel tyre noise (A1)
Arm Type
Experimental
Arm Description
Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level traffic noise comprised of composite wheel types.
Arm Title
Study 2: Low level composite wheel tyre noise (B1)
Arm Type
Experimental
Arm Description
Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by low level traffic noise comprised of composite wheel types.
Arm Title
Study 2: Medium level air-filled tyre noise (A2)
Arm Type
Experimental
Arm Description
Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level traffic noise comprised of traditional air-filled wheel types.
Arm Title
Study 2: Low level air-filled tyre noise (B2)
Arm Type
Experimental
Arm Description
Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by low level traffic noise comprised of traditional air-filled wheel types.
Intervention Type
Radiation
Intervention Name(s)
Tyre noise - continuous flow
Intervention Description
Tyre noise from continuous traffic, throughout the night
Intervention Type
Radiation
Intervention Name(s)
Tyre noise - discrete events
Intervention Description
Tyre noise from few, discrete traffic events, occurring throughout the night
Intervention Type
Radiation
Intervention Name(s)
High noise level
Intervention Description
Tyre noise corresponding up to 65 dB LAEq,24h
Intervention Type
Radiation
Intervention Name(s)
Moderate noise level
Intervention Description
Tyre noise corresponding up to 60 dB LAEq,24h
Intervention Type
Radiation
Intervention Name(s)
Low noise level
Intervention Description
Tyre noise corresponding up to 55 dB LAEq,24h
Intervention Type
Radiation
Intervention Name(s)
Air-filled tyres
Intervention Description
Tyre noise from traditional, air-filled tyres
Intervention Type
Radiation
Intervention Name(s)
Composite tyres
Intervention Description
Tyre noise from newly designed, airless composite tyres
Primary Outcome Measure Information:
Title
Baseline total sleep time during the Control night
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Baseline total sleep time during the A1 night
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Baseline total sleep time during the A2 night
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Baseline total sleep time during the B1 night
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Baseline total sleep time during the B2 night
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total sleep time during exposure to nocturnal tyre noise combination A1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total sleep time during exposure to nocturnal tyre noise combination A2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total sleep time during exposure to nocturnal tyre noise combination B1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total sleep time during exposure to nocturnal tyre noise combination B2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of baseline N1 sleep during the Control night
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of baseline N2 sleep during the Control night
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of baseline N3 sleep during the Control night
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of baseline rapid eye movement (REM) sleep during the Control night
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N1 sleep during exposure to nocturnal tyre noise combination A1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N2 sleep during exposure to nocturnal tyre noise combination A1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N3 sleep during exposure to nocturnal tyre noise combination A1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N1 sleep during exposure to nocturnal tyre noise combination A2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N2 sleep during exposure to nocturnal tyre noise combination A2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N3 sleep during exposure to nocturnal tyre noise combination A2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N1 sleep during exposure to nocturnal tyre noise combination B1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N2 sleep during exposure to nocturnal tyre noise combination B1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N3 sleep during exposure to nocturnal tyre noise combination B1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N1 sleep during exposure to nocturnal tyre noise combination B2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N2 sleep during exposure to nocturnal tyre noise combination B2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of N3 sleep during exposure to nocturnal tyre noise combination B2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Baseline wakefulness after sleep onset (WASO) during the Control night
Description
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A1
Description
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A2
Description
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B1
Description
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B2
Description
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Baseline number of awakenings during the Control night
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Number of awakenings during exposure to nocturnal tyre noise combination A1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Number of awakenings during exposure to nocturnal tyre noise combination A2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Number of awakenings during exposure to nocturnal tyre noise combination B1
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Number of awakenings during exposure to nocturnal tyre noise combination B2
Description
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Time Frame
One night
Title
Baseline sleep onset latency (SOL) during the Control night
Description
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Time Frame
One night
Title
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A1
Description
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Time Frame
One night
Title
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A2
Description
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Time Frame
One night
Title
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B1
Description
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Time Frame
One night
Title
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B2
Description
Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Time Frame
One night
Title
Baseline sleep efficiency during the Control night
Description
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Time Frame
One night
Title
Sleep efficiency during exposure to nocturnal tyre noise combination A1
Description
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Time Frame
One night
Title
Sleep efficiency during exposure to nocturnal tyre noise combination A2
Description
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Time Frame
One night
Title
Sleep efficiency during exposure to nocturnal tyre noise combination B1
Description
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Time Frame
One night
Title
Sleep efficiency during exposure to nocturnal tyre noise combination B2
Description
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
Time Frame
One night
Title
Baseline sleep depth assessed using the odds ratio product (ORP) during the Control night
Description
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Time Frame
One night
Title
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A1
Description
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Time Frame
One night
Title
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A2
Description
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Time Frame
One night
Title
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B1
Description
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Time Frame
One night
Title
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B2
Description
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
Time Frame
One night
Title
Spontaneous maximal change of odds ratio product (ORP) during the Control night
Description
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over 120 sham noise events during the night.
Time Frame
One night
Title
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A1
Description
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Time Frame
One night
Title
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A2
Description
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Time Frame
One night
Title
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B1
Description
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Time Frame
One night
Title
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B2
Description
Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.
Time Frame
One night
Title
Morning neurobehavioural speed in the morning immediately after the Control night
Description
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Time Frame
One night
Title
Morning neurobehavioural speed in the morning immediately after the A1 night
Description
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Time Frame
One night
Title
Morning neurobehavioural speed in the morning immediately after the A2 night
Description
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Time Frame
One night
Title
Morning neurobehavioural speed in the morning immediately after the B1 night
Description
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Time Frame
One night
Title
Morning neurobehavioural speed in the morning immediately after the B2 night
Description
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Time Frame
One night
Title
Morning neurobehavioural accuracy in the morning after the control night
Description
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Time Frame
One night
Title
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A1
Description
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Time Frame
One night
Title
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A2
Description
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Time Frame
One night
Title
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B1
Description
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Time Frame
One night
Title
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B2
Description
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Time Frame
One night
Title
Baseline evening neurobehavioural speed following the Control night
Description
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Time Frame
One night
Title
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A1
Description
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Time Frame
One night
Title
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A2
Description
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Time Frame
One night
Title
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B1
Description
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Time Frame
One night
Title
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B2
Description
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
Time Frame
One night
Title
Baseline evening neurobehavioural accuracy following the Control night
Description
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance
Time Frame
One night
Title
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A1
Description
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Time Frame
One night
Title
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A2
Description
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Time Frame
One night
Title
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B1
Description
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Time Frame
One night
Title
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B2
Description
Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
Time Frame
One night
Title
Event-related Cardiovascular activation in response to noise during Control night
Description
Change in heart rate (ECG)
Time Frame
One night
Title
Event-related Cardiovascular activation in response to noise during A1
Description
Change in heart rate (ECG)
Time Frame
One night
Title
Event-related Cardiovascular activation in response to noise during A2
Description
Change in heart rate (ECG)
Time Frame
One night
Title
Event-related Cardiovascular activation in response to noise during B1
Description
Change in heart rate (ECG)
Time Frame
One night
Title
Event-related Cardiovascular activation in response to noise during B2
Description
Change in heart rate (ECG)
Time Frame
One night
Title
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the control night
Description
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Time Frame
One night
Title
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A1 night
Description
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Time Frame
One night
Title
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A2 night
Description
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Time Frame
One night
Title
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B1 night
Description
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Time Frame
One night
Title
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B2 night
Description
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Time Frame
One night
Title
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the control night
Description
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Time Frame
One night
Title
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A1 night
Description
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Time Frame
One night
Title
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A2 night
Description
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Time Frame
One night
Title
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B1 night
Description
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Time Frame
One night
Title
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B2 night
Description
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)
Time Frame
One night
Title
Taurine concentration (mmol/L) immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Serotonin concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Tryptophan concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Isoleucine concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Leucine concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Valine concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Lauroylcarnitine (C12:0) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Phenylalanine concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 32:1 concentration (mmol/L)In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Basline Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Baseline Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Control night
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night
Title
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
Description
Determined from GC-MS analysis of blood plasma
Time Frame
One night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. live in or around the city of Gothenburg area (Sweden) Exclusion Criteria: aged <18 or >30 years; habitual sleep and wake timings more than ±1 hour different from the study sleep times (i.e. habitual sleep time should be 22:00-00:00 and habitual wake time should be 06:00-08:00); BMI>25 kg/m2; regular sleep medication use (prescribed or "over-the-counter"); poor hearing acuity (measured during screening via pure tone audiometry); diagnosed with sleep disorders; indications of sleep apnea on the STOP-BANG questionnaire; shift work; smoking, vaping, snus, or other nicotine use.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael G Smith, PhD
Phone
+46 31 786 2843
Email
michael.smith@amm.gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G Smith, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Gothenburg
City
Gothenburg
State/Province
Västra Götaland
ZIP/Postal Code
42650
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael G Smith, PhD
Phone
+46317862843
Email
michael.smith@amm.gu.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Low Particle Emission and Low Noise Tyres

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