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Acute Sleep Deprivation on Whole-body Heat Exchange During Exercise-heat Stress in Young and Older Men

Primary Purpose

Thermoregulation, Sleep Disturbance, Heat Exchange

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sleep deprivation
Normal sleep
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Thermoregulation focused on measuring Heat stress, Sleep, Aging, Heat dissipation, Physical activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of OttawaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normal sleep

Sleep deprivation

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dry heat loss
Total dry heat loss as assessed using a direct air calorimeter
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
Core temperature
Rectal temperature measured as an index of core temperature
Change in core temperature
Change in rectal temperature from baseline resting
Heart rate
Measured continuously using a heart rate monitor
Heart rate reserve
Percentage of the difference between the peak heart rate
Local sweat rate (forearm, scapula)
Sweat production assessed using ventilated capsule technique
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%.
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%.
Thermal comfort scale
Thermal comfort assessed via a self-report questionnaire upon verbal prompting (4-point scale; 1: comfortable to 4: very uncomfortable)
Thermal sensation
Thermal sensation assessed via a self-report questionnaire upon verbal prompting (7-point scale; 0: neutral to 7: extremely hot)
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)
Rating of perceived exertion
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion)
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"
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)

Full Information

First Posted
March 30, 2023
Last Updated
April 18, 2023
Sponsor
University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT05838014
Brief Title
Acute Sleep Deprivation on Whole-body Heat Exchange During Exercise-heat Stress in Young and Older Men
Official Title
The Effect of Sleep Deprivation on Whole-body Heat Loss in Young and Older Men During Exercise in Hot, Dry Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thermoregulation, Sleep Disturbance, Heat Exchange, Aging, Exercise
Keywords
Heat stress, Sleep, Aging, Heat dissipation, Physical activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal sleep
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Sleep deprivation
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Sleep deprivation
Intervention Description
Participants will undertake a period of 24 hours of total sleep deprivation prior to completing exercise
Intervention Type
Other
Intervention Name(s)
Normal sleep
Intervention Description
Participants will undertake ~8 hours of normal sleep prior to completing exercise
Primary Outcome Measure Information:
Title
Evaporative heat loss
Description
Evaporative heat loss as assessed using a direct air calorimeter
Time Frame
End of each exercise bout (average of last 5 minutes)
Title
Whole-body heat loss
Description
Net heat loss (dry plus/minus evaporative heat exchange) as assessed using a direct air calorimeter
Time Frame
End of each exercise bout (average of last 5 minutes)
Secondary Outcome Measure Information:
Title
Dry heat loss
Description
Total dry heat loss as assessed using a direct air calorimeter
Time Frame
End of each exercise bout (average of last 5 minutes)
Title
Body heat storage
Description
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
Time Frame
Each 30 minute exercise bout and sum of all three exercise bouts
Title
Core temperature
Description
Rectal temperature measured as an index of core temperature
Time Frame
End of each exercise bout (average of last 5 minutes)
Title
Change in core temperature
Description
Change in rectal temperature from baseline resting
Time Frame
End of each exercise bout (average of last 5 minutes)
Title
Heart rate
Description
Measured continuously using a heart rate monitor
Time Frame
End of each exercise bout (average of last 5 minutes)
Title
Heart rate reserve
Description
Percentage of the difference between the peak heart rate
Time Frame
End of each exercise bout (average of last 5 minutes)
Title
Local sweat rate (forearm, scapula)
Description
Sweat production assessed using ventilated capsule technique
Time Frame
End of each exercise bout (average of last 5 minutes)
Title
Skin temperature
Description
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%.
Time Frame
End of each exercise bout (average of last 5 minutes)
Title
Skin temperature (change)
Description
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%.
Time Frame
End of each exercise bout (average of last 5 minutes)
Title
Thermal comfort scale
Description
Thermal comfort assessed via a self-report questionnaire upon verbal prompting (4-point scale; 1: comfortable to 4: very uncomfortable)
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.
Title
Thermal sensation
Description
Thermal sensation assessed via a self-report questionnaire upon verbal prompting (7-point scale; 0: neutral to 7: extremely hot)
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.
Title
Thirst sensation
Description
Thirst sensation assessed via a self-report questionnaire upon verbal prompting (9-point scale; 1: not thirsty at all to 9: very, very thirsty)
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.
Title
Rating of perceived exertion
Description
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal 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.
Title
Stanford sleep scale
Description
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"
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.
Title
Variables of heart rate variability
Description
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)
Time Frame
End of each exercise (average of last 5 minutes)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Glen P Kenny, PhD
Phone
6135625800
Ext
4282
Email
gkenny@uottawa.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Fergus K O'Connor, PhD
Phone
6136178682
Email
foconnor@uottawa.ca
Facility Information:
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N6N5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glen P Kenny, PhD
Phone
6135625800
Ext
4282
Email
gkenny@uottawa.ca
First Name & Middle Initial & Last Name & Degree
Fergus K O'Connor, PhD
Phone
6136178682
Email
foconnor@uottawa.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data will be made available with approved analysis plan and signed access agreement
IPD Sharing Time Frame
Following publication of the main study (report(s)
IPD Sharing Access Criteria
Approved analysis plan and signed access agreement

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Acute Sleep Deprivation on Whole-body Heat Exchange During Exercise-heat Stress in Young and Older Men

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