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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05838014
Other study ID # HEPRU-2023-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date August 31, 2023

Study information

Verified date April 2023
Source University of Ottawa
Contact Glen P Kenny, PhD
Phone 6135625800
Email gkenny@uottawa.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Sleep deprivation
Participants will undertake a period of 24 hours of total sleep deprivation prior to completing exercise
Normal sleep
Participants will undertake ~8 hours of normal sleep prior to completing exercise

Locations

Country Name City State
Canada University of Ottawa Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaporative heat loss Evaporative heat loss as assessed using a direct air calorimeter End of each exercise bout (average of last 5 minutes)
Primary 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 Dry heat loss Total dry heat loss as assessed using a direct air calorimeter End of each exercise bout (average of last 5 minutes)
Secondary Body heat storage 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 Each 30 minute exercise bout and sum of all three exercise bouts
Secondary Core temperature Rectal temperature measured as an index of core temperature End of each exercise bout (average of last 5 minutes)
Secondary Change in core temperature Change in rectal temperature from baseline resting End of each exercise bout (average of last 5 minutes)
Secondary Heart rate Measured continuously using a heart rate monitor End of each exercise bout (average of last 5 minutes)
Secondary Heart rate reserve Percentage of the difference between the peak heart rate End of each exercise bout (average of last 5 minutes)
Secondary Local sweat rate (forearm, scapula) Sweat production assessed using ventilated capsule technique End of each exercise bout (average of last 5 minutes)
Secondary Skin temperature 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%. End of each exercise bout (average of last 5 minutes)
Secondary Skin temperature (change) 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%. End of each exercise bout (average of last 5 minutes)
Secondary Thermal comfort scale Thermal comfort assessed via a self-report questionnaire upon verbal prompting (4-point scale; 1: comfortable to 4: very uncomfortable) 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.
Secondary Thermal sensation Thermal sensation assessed via a self-report questionnaire upon verbal prompting (7-point scale; 0: neutral to 7: extremely hot) 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.
Secondary Thirst sensation Thirst sensation assessed via a self-report questionnaire upon verbal prompting (9-point scale; 1: not thirsty at all to 9: very, very thirsty) 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.
Secondary Rating of perceived exertion Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion) 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.
Secondary Stanford sleep scale 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" 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.
Secondary Variables of heart rate variability 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) End of each exercise (average of last 5 minutes)
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