NCT05313932

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

March 29, 2022

Last Update Submit

March 29, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • Oxygen uptake

    Change from baseline in oxygen uptake measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise

    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

    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

    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

    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

    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

    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

    From baseline to completion, up to 31 days

Study Arms (2)

Sleep deprivation

EXPERIMENTAL

Two hours of sleep deprivation (Six hours of sleep)

Other: Sleep deprivation

No intervention

NO INTERVENTION

No sleep deprivation (Eight hours of sleep)

Interventions

Participants wake after six hours so that they are deprived of 2 hours of sleep

Sleep deprivation

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Injury-free, trained, male runners

You may not qualify if:

  • Female, untrained, injured

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

April 20, 2022

Primary Completion

August 31, 2022

Study Completion

September 26, 2022

Last Updated

April 6, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share