Sleeping Habits on Performance Following Sleep Deprivation

Sleep Clinical Trial

Official title:

Can Habitual Sleeping Habits Predict Performance Outcomes Following Sleep Deprivation?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942664
• Other study ID #: 23-01-019
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Guelph
• Contact: Philip Millar
• Phone: 519-824-4120
• Email: pmillar[@]uoguelph.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: 1. Can habitual sleeping habits predict, or do different types of sleepers alter, performance outcomes following sleep deprivation? 2. 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? 3. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Athletic Performance
• Hemodynamics
• Sleep
• Sleep Deprivation

Intervention

Behavioral:
• Sleep
Sleep will be restricted to 60% normal sleep duration

Locations

Country	Name	City	State
Canada	University of Guelph - Human Cardiovascular Physiology Laboratory	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting systolic and diastolic blood pressure	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)	During both testing visits (2 time points total)
Other	Resting heart rate	resting heart rate while participant is supine, assessed via ECG	During both testing visits (2 time points total)
Other	Systolic and diastolic blood pressure during exercise	Blood pressure during the VO2peak test, 12-minute warm up, and performance tests, in 2-minute intervals, assessed using an automated oscillometric device	During the introductory visit and during each familiarization visit and testing visit (5 time points total)
Other	Heart rate during exercise	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	During the introductory visit and during each familiarization visit and testing visit (5 time points total)
Other	Gross efficiency during exercise	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.	During each familiarization visit and testing visit (4 time points total)
Other	Oxygen uptake during exercise	Oxygen uptake during the VO2peak test, 12-minute warm up, and performance tests, assessed on a breath-by-breath basis using a metabolic cart	During the introductory visit and during each familiarization visit and testing visit (5 time points total)
Other	Carbon dioxide production during exercise	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	During the introductory visit and during each familiarization visit and testing visit (5 time points total)
Other	Systolic and diastolic blood pressure during recovery	Three minutes of recovery blood pressure following the performance tests, in 1-minute intervals	During each familiarization visit and testing visit (4 time points total)
Other	Heart rate during recovery	Three minutes of heart rate following the performance tests, on a heartbeat-by-beat basis, assessed using a heart rate monitor	During each familiarization visit and testing visit (4 time points total)
Other	Oxygen uptake during recovery	Three minutes of oxygen uptake following the performance tests, assessed breath-by-breath, using a metabolic cart	During each familiarization visit and testing visit (4 time points total)
Other	Carbon dioxide production during recovery	Three minutes of carbon dioxide production following the performance tests, assessed breath-by-breath, using a metabolic cart	During each familiarization visit and testing visit (4 time points total)
Primary	Performance	Mean power achieved during a 20-minute time trial on a cycle ergometer	During each familiarization visit and testing visit (4 time points total)
Secondary	Flow-mediated dilation	Absolute and percent dilation of the superficial femoral artery after 5 minutes of blood flow occlusion	During both testing visits (2 time points total)