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Body Temperature ChangesNCT07664462

Working in the Heat at Simulated Altitude: Effects of Normobaric Hypoxia on Physiological Strain

A study testing Simulated Occupational heat exposure under normoxic conditions and Simulated Occupational heat exposure under hypoxic conditions in people with Body Temperature Changes and Heat Stress, run by University of Ottawa at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Extreme heat events are becoming more frequent, intense, and prolonged, increasing the risk of heat-related illness among workers performing physically demanding work in hot environments. Read more about this study

Who is it for?
Ages 18 to 70 years, men only
What is being tested?
Simulated Occupational heat exposure under normoxic conditions and Simulated Occupational heat exposure under hypoxic conditions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
17 Jun 2026to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are male.
  • Do not smoke or have been smoke free for at least 5 years.
  • English or French speaking.
  • Ability to provide informed consent.
  • Are physically active (engage in exercise at least 2 times per week for ≥30 minutes)

Who cannot join

  • Are regularly exposed to hot environments (e.g., occupational heat exposure)
  • Are regularly exposed to hypoxic environments (e.g., high altitudes)
  • Experience claustrophobia or discomfort in enclosed environments
  • Episode(s) of severe hypoglycemia (requiring the assistance of another person) within the previous year, or inability to sense hypoglycemia (hypoglycemia unawareness).
  • Serious complications related to diabetes (gastroparesis, renal disease, uncontrolled hypertension, severe autonomic neuropathy).
  • Uncontrolled hypertension - BP >150 mmHg systolic or >95 mmHg diastolic in a sitting position.
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  • Restrictions in physical activity due to disease (e.g. intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
  • Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable.
  • Cardiac abnormalities identified during screening

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Glen P Kenny, PhD contact

6135625800 ext. 4282

gkenny@uottawa.ca

Canada1 site, 1 recruiting
  • University of Ottawa

    Ottawa, Ontario, K1N 6N5

    Glen P Kenny, PhD, 613-562-5800 ext. 4282, gkenny@uottawa.ca

    Recruiting

Other trials in Canada

About this study

Official title: Effects of Normobaric Hypoxia on Initial Stay Time and Physiological Strain During Moderate-Intensity Work in the Heat in Young and Older Males

Extreme heat events are becoming more frequent, intense, and prolonged, increasing the risk of heat-related illness among workers performing physically demanding work in hot environments. Occupational heat-stress guidelines use work-rest schedules to limit increases in core temperature and physiological strain, but they do not clearly define the safe maximum duration of continuous work before heat-mitigation controls should begin, known as the initial stay time. Recent work has generated initial stay time recommendations for young and older workers performing moderate-intensity work in the heat; however, these recommendations were developed under normoxic conditions. In many workplaces, heat may occur alongside additional stressors such as hypoxia, including work at altitude or in oxygen-reduced environments. Hypoxia can increase cardiovascular strain, reduce arterial oxygen saturation, and impair exercise tolerance, potentially compromising heat-stress guidance developed under normal oxygen conditions. Older workers may be especially vulnerable because of age-related reductions in thermoregulatory and cardiovascular function. It remains unclear whether hypoxia increases physiological strain during work in the heat or whether current initial stay time and recovery recommendations remain protective under combined heat and hypoxic stress.

The primary objective of this study is to determine whether hypoxia increases physiological strain during moderate-intensity work in the heat in young and older males. Specifically, the study will assess whether normoxia-derived initial stay times and recovery recommendations for work at 29°C wet-bulb globe temperature (37.5°C, 35% RH) remain effective during exposure to 14% inspired oxygen, simulating approximately 3000 m altitude. Healthy young and older males will complete two simulated occupational heat exposures: heat alone and heat plus hypoxia. Participants will perform moderate-intensity treadmill work based on age-specific initial stay times, followed by prescribed work-rest cycles and seated recovery. Core temperature, cardiovascular strain, oxygen saturation, skin temperature, hydration status, perceptual responses, mood, environmental stress symptoms, and cognitive function will be assessed to determine whether hypoxia modifies responses to work in the heat. Findings will help determine whether occupational heat-stress guidance requires refinement for workers exposed to combined heat and hypoxic stress.

Being tested
Simulated Occupational heat exposure under normoxic conditions, Simulated Occupational heat exposure under hypoxic conditions
Keywords
Heat Strain, Thermoregulation, Exercise, Simulated altitude, Core temperature, Occupational Heat Stress, Aging, Hypoxia, Hyperthermia
Medical subject headings
Body Temperature Changes, Heat Stress Disorders, Altitude Sickness, Occupational Stress, Motor Activity, Hypoxia, Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulated Occupational heat exposure under normoxic conditionsOther

    Participants complete a simulated moderate-intensity occupational heat exposure protocol involving treadmill walking in a hot environment (37.5°C, 35% RH) under normoxic conditions (~20.9% inspired oxygen). Participants walk until they reach their initial stay time, followed by prescribed work-rest cycles and seated recovery.

  • Simulated Occupational heat exposure under hypoxic conditionsOther

    Participants complete a simulated moderate-intensity occupational heat exposure protocol involving treadmill walking in a hot environment (37.5°C, 35% RH) with an added hypoxic exposure equivalent to 14% inspired oxygen. Participants walk until they reach their initial stay time, followed by prescribed work-rest cycles and seated recovery.

Study groups in NCT07664462
Study groupRoleWhat they receive
Normoxic exposureExperimentalParticipants complete a simulated moderate-intensity occupational heat exposure protocol in a hot environment (37.5°C, 35% RH) under normoxic conditions. Participants walk on a treadmill until they reach their initial stay time, followed by prescribed work-rest cycles and seated recovery.
Receives: Other: Simulated Occupational heat exposure under normoxic conditions
Hypoxic exposureExperimentalParticipants complete a simulated moderate-intensity occupational heat exposure protocol in a hot environment (37.5°C, 35% RH) with an added hypoxic exposure equivalent to 14% inspired oxygen. Participants walk on a treadmill until they reach their initial stay time, followed by prescribed work-rest cycles and seated recovery.
Receives: Other: Simulated Occupational heat exposure under hypoxic conditions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total work volume

    Total work completed during the 240-minute work bout. The work period consists of an initial continuous walking phase to a core temperature 38.0°C or 1°C increase above baseline resting, followed by intermittent work-rest cycles.

    Measured: During the 240-minute work period

Secondary outcomes (30)
  1. Time to core temperature of 38.0°C

    Time, in minutes, from the start of continuous walking to the point at which core temperature reaches 38.0°C. Participants who do not reach 38.0°C before voluntary termination, reaching the applicable stopping criterion, or completing 240 minutes of continuous walking will have their time recorded at termination or completion.

    Measured: During the 240-minute work period

  2. Time to 1.0°C increase in core temperature

    Time, in minutes, from the start of continuous walking to the point at which rectal temperature increases by 1.0°C above baseline. For participant safety, continuous walking will not continue beyond a rectal temperature of 38.5°C. Therefore, for participants who reach 38.5°C before attaining a 1.0°C increase in rectal temperature, the time at which 38.5°C is reached will be recorded. Participants who voluntarily terminate exercise or complete 240 minutes of continuous walking before reaching either endpoint will have their time recorded at termination or completion.

    Measured: During the 240-minute work period

  3. Average core temperature during work/rest cycles

    Average core temperature measured during the intermittent work-rest cycles following the initial continuous work period.

    Measured: During the 240-minute work period

  4. Heart rate at core temperature of 38.0°C

    Heart rate measured at the time a participant reaches a rectal temperature of 38.0°C during the initial continuous walking period. For participants who do not reach a rectal temperature of 38.0°C before voluntary termination, reaching the applicable stopping criterion, or completing 240 minutes of continuous walking, heart rate at termination or completion will be recorded.

    Measured: During the 240-minute work period

  5. Heart rate at 1.0°C increase in core temperature

    Heart rate measured at the time a participant achieves a 1.0°C increase in core temperature above baseline during the initial continuous walking period. For participant safety, continuous walking will not continue beyond a core temperature of 38.5°C. Therefore, for participants who reach a core temperature of 38.5°C before attaining a 1.0°C increase above baseline, the heart rate at 38.5°C will be recorded. Participants who voluntarily terminate exercise or complete 240 minutes of continuous walking before reaching either endpoint will have their final recorded heart rate used.

    Measured: During the 240-minute work period

  6. Average heart rate during work/rest cycles

    Average heart rate measured during the intermittent work-rest cycles following the initial continuous work period.

    Measured: During the 240-minute work period

  7. Mean skin temperature at core temperature of 38.0°C

    Mean skin temperature measured at the time a participant reaches a core temperature of 38.0°C during the initial continuous walking period. For participants who do not reach a core temperature of 38.0°C before voluntary termination, reaching the applicable stopping criterion, or completing 240 minutes of continuous walking, mean skin temperature at termination or completion will be recorded.

    Measured: During the 240-minute work period

  8. Mean skin temperature at 1.0°C increase in core temperature

    Mean skin temperature measured at the time a participant achieves a 1.0°C increase in core temperature above baseline during the initial continuous walking period. For participant safety, continuous walking will not continue beyond a core temperature of 38.5°C. Therefore, for participants who reach a core temperature of 38.5°C before attaining a 1.0°C increase above baseline, the mean skin temperature at 38.5°C will be recorded. Participants who voluntarily terminate exercise or complete 240 minutes of continuous walking before reaching either endpoint will have their final recorded mean skin temperature used.

    Measured: During the 240-minute work period

  9. Average mean skin temperature during work/rest cycles

    Average mean skin temperature measured during the intermittent work-rest cycles following the initial continuous work period.

    Measured: During the 240-minute work period

  10. Recovery core temperature

    Average core temperature during the recovery period. Core temperature will be measured continuously throughout recovery.

    Measured: During 1 hour recovery following the 240-minute work period

  11. Recovery heart rate

    Average heart rate during the recovery period. Heart rate will be measured continuously throughout recovery.

    Measured: During 1 hour recovery following the 240-minute work period

  12. Recovery mean skin temperature

    Average mean skin temperature during the recovery period. Skin temperature will be measured continuously throughout recovery.

    Measured: During 1 hour recovery following the 240-minute work period

  13. Tissue oxygenation

    Functional near-infrared spectroscopy will be used to continuously assess changes in cerebral and skeletal muscle oxygenation

    Measured: During 240-minute work bout and subsequent 1 hour recovery

  14. Peripheral oxygen saturation

    Peripheral oxygen saturation will be continuously monitored using pulse oximetry to assess the level of arterial oxygen saturation during work and recovery; indicates the degree of hypoxemia and helps determine whether reduced oxygen availability contributes to physiological strain during heat exposure

    Measured: During 240-minute work bout and subsequent 1 hour recovery

  15. Urine specific gravity

    Urine specific gravity will be measured to assess hydration status. Higher values indicate greater urine concentration and therefore poorer hydration status, whereas lower values indicate lower urine concentration and therefore better hydration status.

    Measured: Assessed at baseline and after recovery

  16. Fluid loss from body mass change

    Fluid loss calculated from changes in body mass during exposure, corrected for fluid intake.

    Measured: Assessed at baseline and throughout protocol

  17. Changes in plasma volume

    Change in plasma volume from baseline values calculated from duplicate measurements of hemoglobin and hematocrit at the start and end of exposure using the technique by Dill and Costill

    Measured: Assessed at baseline and after recovery

  18. Systolic blood pressure

    Systolic blood pressure measured in triplicate using automated oscillometry.

    Measured: Assessed at baseline and throughout protocol

  19. Diastolic blood pressure

    Diastolic blood pressure measured in triplicate using automated oscillometry.

    Measured: Assessed at baseline and throughout protocol

  20. Orthostatic hypotension questionnaire

    Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort"

    Measured: Assessed at baseline and throughout protocol

  21. Lake Louise Mountain Sickness Questionnaire

    Assess symptoms of acute mountain sickness, including headache, gastrointestinal discomfort, fatigue/weakness, dizziness/lightheadedness, and sleep disturbance. Each symptom is scored from 0 - 3 and summed for a total score, with higher scores indicating greater symptom severity and acute mountain sickness typically defined as headache plus a total score ≥3.

    Measured: Assessed at baseline and throughout protocol

  22. Thermal sensation scale

    Thermal sensation will be assessed using a visual analog ASHRAE-based scale in response to the question "How hot do you feel?" Scores range from 0 (neutral) to 7 (extremely hot). Higher scores indicate a greater sensation of heat and therefore a worse outcome, whereas lower scores indicate less perceived heat and therefore a better outcome.

    Measured: Assessed at baseline and throughout protocol

  23. Thermal comfort

    Thermal comfort will be assessed in response to the question "How comfortable does your body temperature feel?" using a visual analog scale ranging from 1 (comfortable) to 4 (very uncomfortable). Higher scores indicate lower thermal comfort and therefore a worse outcome, whereas lower scores indicate greater thermal comfort and therefore a better outcome.

    Measured: Assessed at baseline and throughout protocol

  24. Thirst sensation

    Thirst sensation will be assessed in response to the question "How thirsty are you?" using a visual analog scale ranging from 1 (not thirsty at all) to 9 (very, very thirsty). Higher scores indicate greater thirst and therefore a worse outcome, whereas lower scores indicate less thirst and therefore a better outcome.

    Measured: Assessed at baseline and throughout protocol

  25. Rating of Perceived Exertion (Borg 6-20 Scale)

    Perceived exertion will be assessed using a visual analog scale in response to the question "How hard are you working?" Scores range from 6 (no exertion at all) to 20 (maximal exertion). Higher scores indicate greater perceived effort and therefore a worse outcome, whereas lower scores indicate less perceived effort and therefore a better outcome.

    Measured: Assessed during 240-minute work period

  26. Feel-good scale

    Feelings of well-being will be assessed using a visual analog scale in response to the question "How good do you feel?" Scores range from -5 (very bad) to +5 (very good), with 0 representing neutral. Higher scores indicate more positive feelings and therefore a better outcome, whereas lower scores indicate more negative feelings and therefore a worse outcome.

    Measured: Assessed at baseline and throughout protocol

  27. Profiles of Mood States (POMS-40) total mood disturbance score

    Mood state will be assessed using the 40-item Profiles of Mood States (POMS-40) questionnaire. Participants will rate how they feel at the time of assessment using a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). Responses will be summed to generate a total score. Higher scores indicate greater overall mood disturbance and therefore a worse outcome, whereas lower scores indicate lower mood disturbance and therefore a better outcome.

    Measured: Assessed at baseline and end of recovery

  28. Environmental Symptoms Questionnaire-IV (ESQ-IV) total symptom score

    Environmental symptomatology associated with prolonged heat exposure will be assessed using the Environmental Symptoms Questionnaire-IV (ESQ-IV). Participants will rate 68 symptoms using a 6-point Likert scale ranging from 0 (not at all) to 5 (extreme). Responses are summed, with positive items reverse scored as appropriate, to generate a Total Symptom Score ranging from 0 to 340. Higher scores indicate greater symptom burden and therefore a worse outcome, whereas lower scores indicate fewer symptoms and therefore a better outcome.

    Measured: Assessed at baseline and end of recovery

  29. Heart rate variability: standard deviation of normal R-R intervals (SDNN)

    Cardiac autonomic modulation will be assessed using a 5-lead Holter electrocardiogram (ECG) monitor (DigiTrak XT, Philips Zymed, Andover, MA, USA). Consecutive R-R intervals will be derived from the ECG recording to calculate the standard deviation of normal R-R intervals (SDNN), measured in milliseconds (ms). Higher values indicate greater heart rate variability and cardiac autonomic modulation, whereas lower values indicate reduced heart rate variability and cardiac autonomic modulation.

    Measured: During 240-minute work bout and subsequent 1 hour recovery

  30. Heart rate variability: root mean square of successive differences (RMSSD)

    Cardiac autonomic modulation will be assessed using a 5-lead Holter electrocardiogram (ECG) monitor (DigiTrak XT, Philips Zymed, Andover, MA, USA). Consecutive R-R intervals will be derived from the ECG recording to calculate the root mean square of successive differences between adjacent normal R-R intervals (RMSSD), measured in milliseconds (ms). Higher values indicate greater parasympathetic modulation and heart rate variability, whereas lower values indicate reduced parasympathetic modulation and heart rate variability.

    Measured: During 240-minute work bout and subsequent 1 hour recovery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start17 Jun 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07664462
Sponsor's protocol ID
HEPRU-2026-06-B
Status last verified
Jul 2026
First submitted
17 Jun 2026
Last updated
14 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Simulated Occupational heat exposure under normoxic conditions and Simulated Occupational heat exposure under hypoxic conditions in people with Body Temperature Changes and Heat Stress, run by University of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Glen P Kenny, PhD (6135625800 ext. 4282, gkenny@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total work volume (time frame: During the 240-minute work period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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