NCT05838014

Brief Summary

Sleep deprivation has long been thought to modulate thermoregulatory function. Seminal work on sleep deprivation and thermoregulation has demonstrated that sleep-deprived individuals experience greater elevations in core temperature during exercise-heat stress due to reductions in the activation of local heat loss responses of cutaneous vasodilation and sweating. However, it remains unclear 1) if reductions in local heat loss responses would compromise whole-body heat loss (evaporative + dry heat exchange) and 2) if differences exist, are they dependent on the heat load generated by exercise (increases in metabolic rate augments the rate that heat must be dissipated by the body). Further, much of the understanding of the effects of sleep deprivation on thermoregulation has been limited to assessments in young adults. Studies show that aging is associated with reduction in cutaneous vasodilation and sweating that compromise whole-body heat loss exacerbating body heat storage during moderate- and especially more vigorous-intensity exercise in the heat. However, it remains unclear if sleep deprivation may worsen this response in older adults. The purpose of this study is therefore to evaluate the effects of sleep-deprivation on whole-body total heat loss during light, moderate, and vigorous exercise-heat stress and to assess if aging may mediate this response. To achieve this objective, direct calorimetry will be employed to measure whole-body total heat loss in young (18-30 years) and older (50-65 years) men during exercise at increasing, fixed rates of metabolic heat production of 150 (light), 200 (moderate), and 250 W/m2 (vigorous) in dry heat (40°C, \~15% relative humidity) with and without 24 hours of sleep deprivation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

March 30, 2023

Last Update Submit

July 12, 2024

Conditions

Keywords

Heat stressSleepAgingHeat dissipationPhysical activity

Outcome Measures

Primary Outcomes (2)

  • Evaporative heat loss

    Evaporative heat loss as assessed using a direct air calorimeter

    End of each exercise bout (average of last 5 minutes)

  • Whole-body heat loss

    Net heat loss (dry plus/minus evaporative heat exchange) as assessed using a direct air calorimeter

    End of each exercise bout (average of last 5 minutes)

Secondary Outcomes (15)

  • Dry heat loss

    End of each exercise bout (average of last 5 minutes)

  • Body heat storage

    Each 30 minute exercise bout and sum of all three exercise bouts

  • Core temperature

    End of each exercise bout (average of last 5 minutes)

  • Change in core temperature

    End of each exercise bout (average of last 5 minutes)

  • Heart rate

    End of each exercise bout (average of last 5 minutes)

  • +10 more secondary outcomes

Study Arms (2)

Normal sleep

ACTIVE COMPARATOR

Participants will complete three 30-minute bouts of semi-recumbent cycling at incrementally increasing fixed metabolic heat loads (150, 200 and 250 W/m2) in a hot, dry condition (40°C, 15% relative humidity). Each exercise bout will be separated by a 15 minute period of rest, with the final recovery 1 hour in duration. Exercise will commence between the hours of 7 AM and 9 AM following a period of normal sleep (\~8 hours) (Control condition).

Other: Normal sleep

Sleep deprivation

EXPERIMENTAL

Participants will complete three 30-minute bouts of semi-recumbent cycling at incrementally increasing fixed metabolic heat loads (150, 200 and 250 W/m2) in a hot, dry condition (40°C, 15% relative humidity). Each exercise bout will be separated by a 15 minute period of rest, with the final recovery 1 hour in duration. Exercise will commence between the hours of 7 AM and 9 AM following a period of 24 hour of sleep deprivation (Sleep deprivation condition).

Other: Sleep deprivation

Interventions

Participants will undertake a period of 24 hours of total sleep deprivation prior to completing exercise

Sleep deprivation

Participants will undertake \~8 hours of normal sleep prior to completing exercise

Normal sleep

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy young (18-30 years) and older males (50-65 years)
  • non-smoking
  • English or French speaking
  • ability to provide informed consent

You may not qualify if:

  • presence of chronic diseases (e.g., hypertension, diabetes)
  • acute illness (e.g., flu, COVID-19)
  • physical restriction limiting physical activity (e.g., severe arthritis, etc.)
  • use of medication judged by the patient or investigators to make participation in this study inadvisable
  • engaged in regular endurance training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

Related Publications (1)

  • Koetje NJ, Kirby NV, O'Connor FK, Richards BJ, Janetos KT, Ioannou LG, Kenny GP. Effect of 24-h Sleep Deprivation on Whole-Body Heat Loss in Older Males during Exercise in the Heat. Med Sci Sports Exerc. 2025 Dec 1;57(12):2715-2723. doi: 10.1249/MSS.0000000000003812. Epub 2025 Jul 7.

MeSH Terms

Conditions

ParasomniasMotor ActivityHeat Stress Disorders

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersBehaviorWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Each participant will complete two exercise trials in a hot, dry environment (40°C, 15% relative humidity) where they will perform three 30 min bouts of exercise at incrementally increasing metabolic heat loads (each separated by a 15-min rest) following a period of either (i) normal sleep or (ii) 24 h of sleep deprivation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2023

First Posted

May 1, 2023

Study Start

December 1, 2022

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Deidentified participant data will be made available with approved analysis plan and signed access agreement

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Following publication of the main study (report(s)
Access Criteria
Approved analysis plan and signed access agreement

Locations