NCT05942664

Brief 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:

  • 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

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

June 26, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 26, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

June 26, 2023

Last Update Submit

December 3, 2024

Conditions

Keywords

Sleep habitsChronotypeSleep qualityCycling time trial performance

Outcome Measures

Primary Outcomes (1)

  • 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)

Other Outcomes (11)

  • Resting systolic and diastolic blood pressure

    During both testing visits (2 time points total)

  • Resting heart rate

    During both testing visits (2 time points total)

  • Systolic and diastolic blood pressure during exercise

    During the introductory visit and during each familiarization visit and testing visit (5 time points total)

  • +8 more other outcomes

Study Arms (2)

Normal sleep

SHAM COMPARATOR

Participants will be asked to sleep during their normal sleep times prior to this visit

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.

Behavioral: Sleep

Interventions

SleepBEHAVIORAL

Sleep will be restricted to 60% normal sleep duration

Normal sleepSleep deprivation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph - Human Cardiovascular Physiology Laboratory

Guelph, Ontario, N1G2W1, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Sleep

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Philip Millar

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants and investigators are blinded to power output during the time trial
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 12, 2023

Study Start

June 26, 2023

Primary Completion

May 5, 2024

Study Completion

May 6, 2024

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations