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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05942664
Other study ID # 23-01-019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 26, 2023
Est. completion date May 5, 2024

Study information

Verified date May 2024
Source University of Guelph
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 22
Est. completion date May 5, 2024
Est. primary completion date May 5, 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

Study Design


Related Conditions & MeSH terms


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)
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