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Sleeping Habits on Performance Following Sleep Deprivation

Primary Purpose

Sleep, Athletic Performance, Hemodynamics

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sleep
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep focused on measuring Sleep habits, Chronotype, Sleep quality, Cycling time trial performance, Flow-mediated dilation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ages 18-50 years Free of known cardiovascular or metabolic diseases or sleep disorders No history of smoking (within the past 3 months) Able to engage in physical activity assessed through the physical activity readiness questionnaire (PAR-Q+) (answer no to all questions No prescription of chronic medications other than oral contraceptives Able to abide by sleep protocols for all visits Individuals who are not allergic to ultrasound gel Individuals who are able to consume the ingredients of instant oatmeal (whole grain oats, sugar, salt, and natural flavour) Individuals who are not pregnant Exclusion Criteria: Ages <18 years, >50 Individuals diagnosed with cardiovascular or metabolic disease or sleep disorders Has a history of smoking (within the past 3 months) Not ready to engage in physical activity (answer yes to one or more questions in PAR-Q+) Individuals with prescription of chronic medications other than oral contraceptives Unable to abide by sleep protocols for any testing visit Allergic to ultrasound gel Individuals who are unable to consume the ingredients of instant oatmeal (whole grain oats, sugar, salt, and natural flavour) Pregnancy

Sites / Locations

  • University of Guelph - Human Cardiovascular Physiology LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Normal sleep

Sleep deprivation

Arm Description

Participants will be asked to sleep during their normal sleep times prior to this visit

Participants will be asked to go to bed normally but wake up earlier, such that normal sleep duration is restricted by 60%. For example, if someone normally sleeps for 8 hours by falling asleep at 11 pm and waking up at 7 am, they will be asked to fall asleep normally (11 pm) and sleep for 3.2 hours, which results in a wake-up time of 2:12 am.

Outcomes

Primary Outcome Measures

Performance
Mean power achieved during a 20-minute time trial on a cycle ergometer

Secondary Outcome Measures

Flow-mediated dilation
Absolute and percent dilation of the superficial femoral artery after 5 minutes of blood flow occlusion

Full Information

First Posted
June 26, 2023
Last Updated
July 5, 2023
Sponsor
University of Guelph
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1. Study Identification

Unique Protocol Identification Number
NCT05942664
Brief Title
Sleeping Habits on Performance Following Sleep Deprivation
Official Title
Can Habitual Sleeping Habits Predict Performance Outcomes Following Sleep Deprivation?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph

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
The goal of this randomized crossover clinical trial is to determine if habitual sleeping habits can predict endurance performance following a night of partial sleep deprivation in healthy untrained, recreationally trained, and trained cyclists (18-50 years, ~50% females). The main questions it aims to answer are: Can habitual sleeping habits predict, or do different types of sleepers alter, performance outcomes following sleep deprivation? Does sleep deprivation alter blood pressure, heart rate, or metabolic responses during a 20-minute time trial, and/or are these altered amongst different types of sleepers? Can habitual sleeping habits predict, or do different types of sleepers alter, flow-mediated dilation following a night of normal sleep and/or sleep deprivation? Participants will be asked to perform 4 performance tests (20-minute time trial), 2 for familiarization, and 2 testing visits (1 under normal sleep and 1 under partial sleep deprivation). For 1 week prior to each testing visit, sleep will be tracked using an ActiGraph device. During each testing visit, and prior to the performance test, the vascular function of the superficial femoral artery will be assessed using a flow-mediated dilation technique. The investigators hypothesize that habitual early sleepers, poor sleepers, those with greater variability in sleep duration, and females will show the greatest impairments in performance and flow-mediated dilation following partial sleep deprivation.
Detailed Description
Five separate visits will take place. Participants will be asked to abstain from heavy exercise, napping, alcohol, recreational drugs, and acute supplementation or medication use (i.e., melatonin, antihistamines) 24 hours before each visit. The first visit will always be the introductory visit, which will be followed by two familiarization visits. The next two visits will be testing visits and randomized (one normal sleep visit and one sleep deprivation visit). Introductory visit: Prior to arriving at the lab, participants will read over and sign the consent form, complete the Pittsburgh Sleep Quality Index (PSQI), complete the Morningness-Eveningness Questionnaire (MEQ), complete a general health questionnaire, and complete the PAR-Q+ remotely. After obtaining consent and upon arriving at the lab, height and weight will be measured. This will be followed by a maximal exercise test to assess peak oxygen uptake (VO2peak) on a cycle ergometer. After this, participants will be given a rest period, which will be followed by the completion of a 5-minute time trial so the participant can get familiarized with pushing themselves during the performance test. Pre-testing: Participants will be equipped with an ActiGraph device to measure sleeping patterns over a 1-week time frame prior to each testing visit as well as the night prior to each familiarization visit. These data will then be used to determine each participant's sleep-wake schedule for the testing visits. Furthermore, the day prior to each familiarization visit and testing visit, participants will be asked to complete a food diary using an online app (MyFitnessPal), which will ask participants to list the ingredients and quantity of each ingredient consumed for each meal and beverage that day, night and subsequent day. Participants will be asked to abstain from food for 4 hours upon arriving at the lab, prior to each familiarization and testing visit. Familiarization visits: Upon lab arrival, participants will be provided with a standardized snack, which includes instant Quaker oats mixed with water. The amount will be based on body weight (1 gram of carbohydrates per body weight in kilograms). Following this, the participant will complete a 20-minute time trial on a cycle ergometer. Testing visits: Upon lab arrival, participants will lay supine quietly, and resting hemodynamic measurements (blood pressure and heart rate) will commence. Following this, the researcher will perform a flow-mediated dilation test to assess vascular function of the superficial femoral artery. This will be followed by consuming the same standardized snack as the familiarization visit, and then a 20-minute time trial on a cycle ergometer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Athletic Performance, Hemodynamics
Keywords
Sleep habits, Chronotype, Sleep quality, Cycling time trial performance, Flow-mediated dilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
Flow-mediated dilation analysis will be blinded by the assessor by having a second party rename files to ensure they are unidentifiable.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal sleep
Arm Type
Sham Comparator
Arm Description
Participants will be asked to sleep during their normal sleep times prior to this visit
Arm Title
Sleep deprivation
Arm Type
Active Comparator
Arm Description
Participants will be asked to go to bed normally but wake up earlier, such that normal sleep duration is restricted by 60%. For example, if someone normally sleeps for 8 hours by falling asleep at 11 pm and waking up at 7 am, they will be asked to fall asleep normally (11 pm) and sleep for 3.2 hours, which results in a wake-up time of 2:12 am.
Intervention Type
Behavioral
Intervention Name(s)
Sleep
Intervention Description
Sleep will be restricted to 60% normal sleep duration
Primary Outcome Measure Information:
Title
Performance
Description
Mean power achieved during a 20-minute time trial on a cycle ergometer
Time Frame
During each familiarization visit and testing visit (4 time points total)
Secondary Outcome Measure Information:
Title
Flow-mediated dilation
Description
Absolute and percent dilation of the superficial femoral artery after 5 minutes of blood flow occlusion
Time Frame
During both testing visits (2 time points total)
Other Pre-specified Outcome Measures:
Title
Resting systolic and diastolic blood pressure
Description
Resting blood pressure while participant is supine, assessed in 1-minute intervals through an automated oscillometric device and non-invasive, continuous blood pressure (i.e., on a heartbeat-by-beat basis)
Time Frame
During both testing visits (2 time points total)
Title
Resting heart rate
Description
resting heart rate while participant is supine, assessed via ECG
Time Frame
During both testing visits (2 time points total)
Title
Systolic and diastolic blood pressure during exercise
Description
Blood pressure during the VO2peak test, 12-minute warm up, and performance tests, in 2-minute intervals, assessed using an automated oscillometric device
Time Frame
During the introductory visit and during each familiarization visit and testing visit (5 time points total)
Title
Heart rate during exercise
Description
Heart rate during the VO2peak test, 12-minute warm up, and performance tests, on a heartbeat-by-beat basis, assessed using a heart rate monitor
Time Frame
During the introductory visit and during each familiarization visit and testing visit (5 time points total)
Title
Gross efficiency during exercise
Description
Movement efficiency during the 12-minute warm up, prior to the performance tests. This will be calculated using the following formula: (work (J)/energy expenditure (J))*100. Work is calculated as: (watts during the warm up * time) and energy production is determined by the metabolic cart, and will be further broken down into joules by multiplying energy expenditure in kcals by 4184.
Time Frame
During each familiarization visit and testing visit (4 time points total)
Title
Oxygen uptake during exercise
Description
Oxygen uptake during the VO2peak test, 12-minute warm up, and performance tests, assessed on a breath-by-breath basis using a metabolic cart
Time Frame
During the introductory visit and during each familiarization visit and testing visit (5 time points total)
Title
Carbon dioxide production during exercise
Description
Carbon dioxide production during the VO2peak test, 12-minute warm up, and performance tests, assessed on a breath-by-breath basis using a metabolic cart
Time Frame
During the introductory visit and during each familiarization visit and testing visit (5 time points total)
Title
Systolic and diastolic blood pressure during recovery
Description
Three minutes of recovery blood pressure following the performance tests, in 1-minute intervals
Time Frame
During each familiarization visit and testing visit (4 time points total)
Title
Heart rate during recovery
Description
Three minutes of heart rate following the performance tests, on a heartbeat-by-beat basis, assessed using a heart rate monitor
Time Frame
During each familiarization visit and testing visit (4 time points total)
Title
Oxygen uptake during recovery
Description
Three minutes of oxygen uptake following the performance tests, assessed breath-by-breath, using a metabolic cart
Time Frame
During each familiarization visit and testing visit (4 time points total)
Title
Carbon dioxide production during recovery
Description
Three minutes of carbon dioxide production following the performance tests, assessed breath-by-breath, using a metabolic cart
Time Frame
During each familiarization visit and testing visit (4 time points total)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages 18-50 years Free of known cardiovascular or metabolic diseases or sleep disorders No history of smoking (within the past 3 months) Able to engage in physical activity assessed through the physical activity readiness questionnaire (PAR-Q+) (answer no to all questions No prescription of chronic medications other than oral contraceptives Able to abide by sleep protocols for all visits Individuals who are not allergic to ultrasound gel Individuals who are able to consume the ingredients of instant oatmeal (whole grain oats, sugar, salt, and natural flavour) Individuals who are not pregnant Exclusion Criteria: Ages <18 years, >50 Individuals diagnosed with cardiovascular or metabolic disease or sleep disorders Has a history of smoking (within the past 3 months) Not ready to engage in physical activity (answer yes to one or more questions in PAR-Q+) Individuals with prescription of chronic medications other than oral contraceptives Unable to abide by sleep protocols for any testing visit Allergic to ultrasound gel Individuals who are unable to consume the ingredients of instant oatmeal (whole grain oats, sugar, salt, and natural flavour) Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Millar
Phone
519-824-4120
Ext
54818
Email
pmillar@uoguelph.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Millar
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guelph - Human Cardiovascular Physiology Laboratory
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G2W1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Millar

12. IPD Sharing Statement

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Sleeping Habits on Performance Following Sleep Deprivation

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