SleepNCT05942664
Sleeping Habits on Performance Following Sleep Deprivation
A study testing Sleep in people with Sleep and Athletic Performance, run by University of Guelph at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Athletic Performance, Hemodynamics
- What is being tested?
- Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jun 2023to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 able to consume the ingredients of instant oatmeal (whole grain oats, sugar, salt, and natural flavour)
- Individuals who are not pregnant
Who cannot join
- 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
- Individuals who are unable to consume the ingredients of instant oatmeal (whole grain oats, sugar, salt, and natural flavour)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Guelph - Human Cardiovascular Physiology Laboratory
Guelph, Ontario, N1G2W1
About this study
Official title: Can Habitual Sleeping Habits Predict Performance Outcomes Following Sleep Deprivation?
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?
Read more
- 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.
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 following partial sleep deprivation.
Read the 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, participants will consume the same standardized snack as the familiarization visit, and then a 20-minute time trial on a cycle ergometer.
- Conditions
- Sleep, Athletic Performance, Hemodynamics
- Being tested
- Sleep
- Keywords
- Sleep habits, Chronotype, Sleep quality, Cycling time trial performance
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepBehavioural
Sleep will be restricted to 60% normal sleep duration
| Study group | Role | What they receive |
|---|---|---|
| Normal sleep | Sham comparator | Participants will be asked to sleep during their normal sleep times prior to this visit Receives: Behavioral: Sleep |
| Sleep deprivation | Active comparator | 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. Receives: Behavioral: Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Mean power achieved during a 20-minute time trial on a cycle ergometer
Measured: During each familiarization visit and testing visit (4 time points total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start26 Jun 2023
- Primary completion5 May 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Millar, University of Guelph
- Investigators
- Philip Millar, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942664
- Sponsor's protocol ID
- 23-01-019
- Status last verified
- Dec 2024
- First submitted
- 26 Jun 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Habitual Sleeping Habits Predict Performance Outcomes Following Sleep Deprivation?
- ClinicalTrials.gov ID
- NCT05942664
- Acronym / sponsor ID
- 23-01-019
- Conditions
- Sleep, Athletic Performance, Hemodynamics
- Keywords
- Sleep habits, Chronotype, Sleep quality, Cycling time trial performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
- 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.
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 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, participants will consume the same standardized snack as the familiarization visit, and then a 20-minute time trial on a cycle ergometer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal sleep | Sham comparator | Behavioral: SleepParticipants will be asked to sleep during their normal sleep times prior to this visit |
| Sleep deprivation | Active comparator | Behavioral: SleepParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SleepSleep will be restricted to 60% normal sleep duration | Behavioural | Normal sleep, Sleep deprivation |
Primary outcome
Performance
Time frame: During each familiarization visit and testing visit (4 time points total)
Mean power achieved during a 20-minute time trial on a cycle ergometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Millar principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep in people with Sleep and Athletic Performance, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: During each familiarization visit and testing visit (4 time points total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.