- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05838014
Acute Sleep Deprivation on Whole-body Heat Exchange During Exercise-heat Stress in Young and Older Men
The Effect of Sleep Deprivation on Whole-body Heat Loss in Young and Older Men During Exercise in Hot, Dry Conditions
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1N6N5
- University of Ottawa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy young (18-30 years) and older males (50-65 years)
- non-smoking
- English or French speaking
- ability to provide informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Normal sleep
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).
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Participants will undertake ~8 hours of normal sleep prior to completing exercise
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Experimental: Sleep deprivation
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).
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Participants will undertake a period of 24 hours of total sleep deprivation prior to completing exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaporative heat loss
Time Frame: End of each exercise bout (average of last 5 minutes)
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Evaporative heat loss as assessed using a direct air calorimeter
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End of each exercise bout (average of last 5 minutes)
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Whole-body heat loss
Time Frame: End of each exercise bout (average of last 5 minutes)
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Net heat loss (dry plus/minus evaporative heat exchange) as assessed using a direct air calorimeter
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End of each exercise bout (average of last 5 minutes)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dry heat loss
Time Frame: End of each exercise bout (average of last 5 minutes)
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Total dry heat loss as assessed using a direct air calorimeter
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End of each exercise bout (average of last 5 minutes)
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Body heat storage
Time Frame: Each 30 minute exercise bout and sum of all three exercise bouts
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Change in body heat storage (i.e., amount of heat stored in the body) calculated as the temporal summation of metabolic heat production and net heat loss
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Each 30 minute exercise bout and sum of all three exercise bouts
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Core temperature
Time Frame: End of each exercise bout (average of last 5 minutes)
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Rectal temperature measured as an index of core temperature
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End of each exercise bout (average of last 5 minutes)
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Change in core temperature
Time Frame: End of each exercise bout (average of last 5 minutes)
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Change in rectal temperature from baseline resting
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End of each exercise bout (average of last 5 minutes)
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Heart rate
Time Frame: End of each exercise bout (average of last 5 minutes)
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Measured continuously using a heart rate monitor
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End of each exercise bout (average of last 5 minutes)
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Heart rate reserve
Time Frame: End of each exercise bout (average of last 5 minutes)
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Percentage of the difference between the peak heart rate
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End of each exercise bout (average of last 5 minutes)
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Local sweat rate (forearm, scapula)
Time Frame: End of each exercise bout (average of last 5 minutes)
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Sweat production assessed using ventilated capsule technique
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End of each exercise bout (average of last 5 minutes)
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Skin temperature
Time Frame: End of each exercise bout (average of last 5 minutes)
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Skin temperature measured continuously at 4-sites (chest, upper arm, thigh, calf) with mean value calculated as weighted value of 4 sites - bicep, 30%; chest, 30%; thigh, 20%; and calf, 20%.
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End of each exercise bout (average of last 5 minutes)
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Skin temperature (change)
Time Frame: End of each exercise bout (average of last 5 minutes)
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Change in skin temperature from baseline resting as assessed at 4-sites (chest, upper arm, thigh, calf) with mean value calculated as weighted value of 4 sites - bicep, 30%; chest, 30%; thigh, 20%; and calf, 20%.
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End of each exercise bout (average of last 5 minutes)
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Thermal comfort scale
Time Frame: End of the 30 minute resting baseline period, end of each 30 minute exercise bout, end of each 15 minute rest period, and 1 hour after final exercise period.
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Thermal comfort assessed via a self-report questionnaire upon verbal prompting (4-point scale; 1: comfortable to 4: very uncomfortable)
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End of the 30 minute resting baseline period, end of each 30 minute exercise bout, end of each 15 minute rest period, and 1 hour after final exercise period.
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Thermal sensation
Time Frame: End of the 30 minute resting baseline period, end of each 30 minute exercise bout, end of each 15 minute rest period, and 1 hour after final exercise period.
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Thermal sensation assessed via a self-report questionnaire upon verbal prompting (7-point scale; 0: neutral to 7: extremely hot)
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End of the 30 minute resting baseline period, end of each 30 minute exercise bout, end of each 15 minute rest period, and 1 hour after final exercise period.
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Thirst sensation
Time Frame: End of the 30 minute resting baseline period, end of each 30 minute exercise bout, end of each 15 minute rest period, and 1 hour after final exercise period.
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Thirst sensation assessed via a self-report questionnaire upon verbal prompting (9-point scale; 1: not thirsty at all to 9: very, very thirsty)
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End of the 30 minute resting baseline period, end of each 30 minute exercise bout, end of each 15 minute rest period, and 1 hour after final exercise period.
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Rating of perceived exertion
Time Frame: End of the 30 minute resting baseline period, end of each 30 minute exercise bout, end of each 15 minute rest period, and 1 hour after final exercise period.
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Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion)
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End of the 30 minute resting baseline period, end of each 30 minute exercise bout, end of each 15 minute rest period, and 1 hour after final exercise period.
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Stanford sleep scale
Time Frame: End of the 30 minute resting baseline period, end of each 30 minute exercise bout, end of each 15 minute rest period, and 1 hour after final exercise period.
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Symptoms of tiredness assess via a self-report questionnaire upon verbal prompting (How sleepy are you?) ranging from "feeling active, vital, alert, or wide awake" to "no longer fighting sleep, sleep onset soon, having dream-like thoughts"
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End of the 30 minute resting baseline period, end of each 30 minute exercise bout, end of each 15 minute rest period, and 1 hour after final exercise period.
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Variables of heart rate variability
Time Frame: End of each exercise (average of last 5 minutes)
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Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains (R-R interval data extracted from the electrocardiogram)
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End of each exercise (average of last 5 minutes)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEPRU-2023-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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