Sleep DeprivationNCT05313932
The Effects of Sleep Deprivation on Physiological and Perceptual Responses During Exercise
A study testing Sleep deprivation in people with Sleep Deprivation, run by St Mary's University College.
Trial summary
Sleep deprivation has been found to impact exercise performance. The effects of both partial (several hours) and full (24+ hours) sleep deprivation on exercise performance has shown effects on rating of perceived exertion, rate of oxygen consumption, respiratory exchange ratio, and heart rate. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Sleep deprivation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2022to 26 Sep 2022
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Injury-free, trained, male runners
Who cannot join
- Female, untrained, injured
About this study
Official title: The Effects of Partial Sleep Restriction on Physiological and Perceptual Responses During Submaximal and Maximal Exercise in Trained Runners
Sleep deprivation has been found to impact exercise performance. The effects of both partial (several hours) and full (24+ hours) sleep deprivation on exercise performance has shown effects on rating of perceived exertion, rate of oxygen consumption, respiratory exchange ratio, and heart rate. A common practice with athletes is to perform regular physiological testing (submaximal and maximal) in order to assess their fitness and to determine training intensities. However, the effects of sleep deprivation on those same physiological test results has not been investigated Therefore, the purpose of this study is to investigate the effects of partial sleep deprivation on physiological test results.
- Conditions
- Sleep Deprivation
- Being tested
- Sleep deprivation
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationOther
Participants wake after six hours so that they are deprived of 2 hours of sleep
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation | Experimental | Two hours of sleep deprivation (Six hours of sleep) Receives: Other: Sleep deprivation |
| No intervention | No intervention | No sleep deprivation (Eight hours of sleep) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen uptake
Change from baseline in oxygen uptake measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise
Measured: From baseline to completion, up to 31 days
Respiratory exchange ratio
Change from baseline in respiratory exchange ratio measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise
Measured: From baseline to completion, up to 31 days
Breathing frequency
Change from baseline in breathing frequency measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise
Measured: From baseline to completion, up to 31 days
Minute ventilation
Change from baseline in minute ventilation measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise
Measured: From baseline to completion, up to 31 days
Blood lactate concentration
Change from baseline in blood lactate concentration measured using capillary puncture during submaximal and maximal incremental exercise
Measured: From baseline to completion, up to 31 days
Rating of perceived exertion
Change from baseline in ratings of perceived exertion measured using a 15-point (6-20) scale during submaximal and maximal incremental exercise
Measured: From baseline to completion, up to 31 days
Heart rate
Change from baseline in heart rate measured using a heart rate monitor during submaximal and maximal incremental exercise
Measured: From baseline to completion, up to 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start20 Apr 2022 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion26 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313932
- Sponsor's protocol ID
- StMarysUC4
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Partial Sleep Restriction on Physiological and Perceptual Responses During Submaximal and Maximal Exercise in Trained Runners
- ClinicalTrials.gov ID
- NCT05313932
- Acronym / sponsor ID
- StMarysUC4
- Conditions
- Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Study start
- 20 Apr 2022 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 26 Sep 2022 (estimated)
- First posted
- 6 Apr 2022 (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.
Sleep deprivation has been found to impact exercise performance. The effects of both partial (several hours) and full (24+ hours) sleep deprivation on exercise performance has shown effects on rating of perceived exertion, rate of oxygen consumption, respiratory exchange ratio, and heart rate. A common practice with athletes is to perform regular physiological testing (submaximal and maximal) in order to assess their fitness and to determine training intensities. However, the effects of sleep deprivation on those same physiological test results has not been investigated Therefore, the purpose of this study is to investigate the effects of partial sleep deprivation on physiological test results.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | Experimental | Other: Sleep deprivationTwo hours of sleep deprivation (Six hours of sleep) |
| No intervention | No intervention | –No sleep deprivation (Eight hours of sleep) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Injury-free, trained, male runners
Key exclusion criteria (1 listed)
- Female, untrained, injured
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 |
|---|---|---|
| Sleep deprivationParticipants wake after six hours so that they are deprived of 2 hours of sleep | Other | Sleep deprivation |
Primary outcome
Oxygen uptake
Time frame: From baseline to completion, up to 31 days
Change from baseline in oxygen uptake measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise
Respiratory exchange ratio
Time frame: From baseline to completion, up to 31 days
Change from baseline in respiratory exchange ratio measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise
Breathing frequency
Time frame: From baseline to completion, up to 31 days
Change from baseline in breathing frequency measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise
Minute ventilation
Time frame: From baseline to completion, up to 31 days
Change from baseline in minute ventilation measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise
Blood lactate concentration
Time frame: From baseline to completion, up to 31 days
Change from baseline in blood lactate concentration measured using capillary puncture during submaximal and maximal incremental exercise
Rating of perceived exertion
Time frame: From baseline to completion, up to 31 days
Change from baseline in ratings of perceived exertion measured using a 15-point (6-20) scale during submaximal and maximal incremental exercise
Heart rate
Time frame: From baseline to completion, up to 31 days
Change from baseline in heart rate measured using a heart rate monitor during submaximal and maximal incremental exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation in people with Sleep Deprivation, run by St Mary's University College.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Oxygen uptake (time frame: From baseline to completion, up to 31 days). The study lists 7 primary outcomes in all. 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 Apr 2022.