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Cortical Excitability and Decision Making After Total Sleep Deprivation and Sleep Restriction

Primary Purpose

Acute and Partial Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Sleep Deprivation
Sponsored by
Christian Baumann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute and Partial Sleep Deprivation

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male (in female subjects, menstrual cycle influences sleep)
  • Age between 18-35 years
  • Right-handedness
  • Good general health
  • Signed Informed Consent after being informed

Exclusion Criteria:

  • Contraindications on ethical grounds
  • Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc)
  • Known or suspected non-compliance, drug or alcohol abuse (> 5dl wine/ >1l beer daily)
  • Regular medication intake
  • Enrolment into a clinical trial within last 4 weeks
  • History of seizure or a family history of epilepsy
  • Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases)
  • History of any moderate or heavy head trauma
  • Sleep disorders (e.g. Insomnia, sleep apnea, restless leg syndrome, narcolepsy, etc.)
  • Sleep complaints in general or EDS
  • Irregular sleep-wake rhythm (e.g. shift working)
  • Long (> 9 hours per night) or short sleepers (< 7hours per night)
  • Sleep efficiency ≤ 80%
  • Travelling with time lag less than 1 month ago (or planning to do so within 1 month prior to the study)

  • Body Mass Index < 19 or > 30 kg/m2

    • 5 drinks or food items containing caffeine per day
    • 10 cigarettes per day
  • Student of one of the following subjects: Mathematics, Physics, Computer Science, Economics, or Psychology (since students of these subjects have profound knowledge of probability calculations, which could interfere with our measurements in decision making)
  • The following additional exclusion criteria apply only to subjects with TMS sessions
  • History of frequent and/or heavy headache respectively migraine
  • History of claustrophobia
  • Hearing disorder
  • Magnetic Resonance Imaging (MRI) contraindication (such as pacemaker implanted pumps, shrapnel, etc.; full MRI screening form will be filled out - see -Entrance questionnaires)
  • No clear TMS evoked potential in the target area during the screening assessment
  • These subjects will be invited to participate in the study with no TMS sessions, the other protocol being identical

Sites / Locations

  • University Hospital Zurich, Division of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SDSR

SRSD

Arm Description

first total then partial Sleep deprivation

first partial then total Sleep deprivation

Outcomes

Primary Outcome Measures

Change in cortical excitability after Chronic Sleep Deprivation as measured by TMS evoked responses in the EEG
amount of activation in the electroencephalography (EEG) evoked by single-pulse transcranial magnetic stimulation (TMS)
Change in Reaction Times after Chronic Sleep Deprivation as measured by the Psychomotor Vigilance Task
Reaction times in the Psychomotor vigilance task
Change in risk taking and financial impulsivity as measured by the Amount of risky options chosen in the risk task and the amount of financial impulsive choices in the Delay Discount Task
Risk Task (adapted from Levy et al.) Delay Discounting Task (Kirby et al.)

Secondary Outcome Measures

Slow Wave Activity during Sleep as measured by the power in the EEG in the frequency range of 1-4.5 Hz
Slow wave activity recorded during the night in the electroencephalography
Dim Light Melatonin Onset as measured by the melatonin concentration in hourly collected saliva samples
Melatonin concentration curve in saliva samples collected hourly prior to going to bed
Skin Temperature profiles as measured by skin temperature sensors (Celsius)
Skin temperature (Celsius) is measured every 5 minutes
Mood ratings as measured by a visual analog scale
Mood Ratings from 1-10
subjective sleepines as measured by the stanford sleepiness scale
Stanford sleepiness scale
Working Memory performance as measured by errors of comission and omission the n-back Task
2-back and 3-back task: measures of comission and omission
metabolic profile as measured by metabolites in saliva
Screening for metabolites that are changes due to sleep loss

Full Information

First Posted
November 7, 2014
Last Updated
November 18, 2020
Sponsor
Christian Baumann
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1. Study Identification

Unique Protocol Identification Number
NCT02305225
Brief Title
Cortical Excitability and Decision Making After Total Sleep Deprivation and Sleep Restriction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christian Baumann

4. Oversight

5. Study Description

Brief Summary
The investigators examine changes in decision making, vigilance and cortical excitability in healthy male subjects undergoing total acute sleep deprivation (40 hours) on the one hand, and chronic partial sleep restriction (7 nights with 5 instead of 8 hours in bed per night) on the other hand, in a cross over controlled manner. The investigators hypothesize that total sleep deprivation, as well as partial sleep restriction lead to impairments in decision making and vigilance, and enhanced cortical excitability. Beside these three primary outcomes, the investigators also assess changes in sleep by EEG, dim light melatonin onset, skin temperature, subjective mood and sleepiness, working memory, and also collect saliva samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute and Partial Sleep Deprivation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SDSR
Arm Type
Experimental
Arm Description
first total then partial Sleep deprivation
Arm Title
SRSD
Arm Type
Experimental
Arm Description
first partial then total Sleep deprivation
Intervention Type
Behavioral
Intervention Name(s)
Sleep Deprivation
Primary Outcome Measure Information:
Title
Change in cortical excitability after Chronic Sleep Deprivation as measured by TMS evoked responses in the EEG
Description
amount of activation in the electroencephalography (EEG) evoked by single-pulse transcranial magnetic stimulation (TMS)
Time Frame
Change from Baseline to after 7 nights of chronic Sleep Deprivation
Title
Change in Reaction Times after Chronic Sleep Deprivation as measured by the Psychomotor Vigilance Task
Description
Reaction times in the Psychomotor vigilance task
Time Frame
Change from Baseline to after 7 nights of chronic Sleep Deprivation
Title
Change in risk taking and financial impulsivity as measured by the Amount of risky options chosen in the risk task and the amount of financial impulsive choices in the Delay Discount Task
Description
Risk Task (adapted from Levy et al.) Delay Discounting Task (Kirby et al.)
Time Frame
Change from Baseline to after 7 nights of chronic Sleep Deprivation
Secondary Outcome Measure Information:
Title
Slow Wave Activity during Sleep as measured by the power in the EEG in the frequency range of 1-4.5 Hz
Description
Slow wave activity recorded during the night in the electroencephalography
Time Frame
Baseline, 1st Recovery Night of total Sleep Deprivation, 5th, 6th, 7th night of partial Sleep Deprivation, 1st Recovery Night from partial Sleep Deprivation
Title
Dim Light Melatonin Onset as measured by the melatonin concentration in hourly collected saliva samples
Description
Melatonin concentration curve in saliva samples collected hourly prior to going to bed
Time Frame
Baseline, 1st evening after partial Sleep Deprivation, 7th to 14th evening after partial Sleep Deprivation
Title
Skin Temperature profiles as measured by skin temperature sensors (Celsius)
Description
Skin temperature (Celsius) is measured every 5 minutes
Time Frame
from 1 week prior to partial Sleep Deprivation to 8-14 days after
Title
Mood ratings as measured by a visual analog scale
Description
Mood Ratings from 1-10
Time Frame
2 Baseline Days (prior to both parts), 1st Day of total Sleep Deprivation, 1st Day of Recovery from total Sleep Deprivation, 6th, 7th & 8th Day of partial Sleep Deprivation, 8th to 14th Day of Recovery from partial Sleep Deprivation
Title
subjective sleepines as measured by the stanford sleepiness scale
Description
Stanford sleepiness scale
Time Frame
2 Baseline Days (prior to both parts), 1st Day of total Sleep Deprivation, 1st Day of Recovery from total Sleep Deprivation, 6th, 7th & 8th Day of partial Sleep Deprivation, 8th to 14th Day of Recovery from partial Sleep Deprivation
Title
Working Memory performance as measured by errors of comission and omission the n-back Task
Description
2-back and 3-back task: measures of comission and omission
Time Frame
2 Baseline Days (prior to both parts), 1st Day of total Sleep Deprivation, 1st Day of Recovery from total Sleep Deprivation, 6th, 7th & 8th Day of partial Sleep Deprivation, 8th to 14th Day of Recovery from partial Sleep Deprivation
Title
metabolic profile as measured by metabolites in saliva
Description
Screening for metabolites that are changes due to sleep loss
Time Frame
Baseline Day 1, 1st Day of total Sleep Deprivation, 8th Day of partial Sleep Deprivation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male (in female subjects, menstrual cycle influences sleep) Age between 18-35 years Right-handedness Good general health Signed Informed Consent after being informed Exclusion Criteria: Contraindications on ethical grounds Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc) Known or suspected non-compliance, drug or alcohol abuse (> 5dl wine/ >1l beer daily) Regular medication intake Enrolment into a clinical trial within last 4 weeks History of seizure or a family history of epilepsy Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases) History of any moderate or heavy head trauma Sleep disorders (e.g. Insomnia, sleep apnea, restless leg syndrome, narcolepsy, etc.) Sleep complaints in general or EDS Irregular sleep-wake rhythm (e.g. shift working) Long (> 9 hours per night) or short sleepers (< 7hours per night) Sleep efficiency ≤ 80% Travelling with time lag less than 1 month ago (or planning to do so within 1 month prior to the study) Body Mass Index < 19 or > 30 kg/m2 5 drinks or food items containing caffeine per day 10 cigarettes per day Student of one of the following subjects: Mathematics, Physics, Computer Science, Economics, or Psychology (since students of these subjects have profound knowledge of probability calculations, which could interfere with our measurements in decision making) The following additional exclusion criteria apply only to subjects with TMS sessions History of frequent and/or heavy headache respectively migraine History of claustrophobia Hearing disorder Magnetic Resonance Imaging (MRI) contraindication (such as pacemaker implanted pumps, shrapnel, etc.; full MRI screening form will be filled out - see -Entrance questionnaires) No clear TMS evoked potential in the target area during the screening assessment These subjects will be invited to participate in the study with no TMS sessions, the other protocol being identical
Facility Information:
Facility Name
University Hospital Zurich, Division of Neurology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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Cortical Excitability and Decision Making After Total Sleep Deprivation and Sleep Restriction

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