Recruiting

Heat & Hypoxia

Sponsor:

University of Ottawa

Code:

NCT07664462

Conditions

Body Temperature Changes

Heat Stress

Heat Exposure

Heat Fatigue

Hypoxia, Altitude

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Simulated Occupational heat exposure under normoxic conditions

Simulated Occupational heat exposure under hypoxic conditions

Study Details

Brief 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. 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.

Conditions

Body Temperature Changes

Heat Stress

Heat Exposure

Heat Fatigue

Hypoxia, Altitude

Study ID

NCT07664462

Start date

Jun 17, 2026

Status verified date

Jul, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Normoxic exposure

Participants 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.

experimental: Hypoxic exposure

Participants 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.

Interventions

Simulated Occupational heat exposure under normoxic conditions

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 conditions

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.

Primary outcome measure

  • Total work volume [ Time Frame: During the 240-minute work period ]

Central Contacts and Locations

Central contacts

Locations

University of Ottawa

Recruiting

Ottawa, Ontario, Canada, K1N 6N5

Contacts

More Information

Sponsor

University of Ottawa

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Heat Strain
  • Thermoregulation
  • Exercise
  • Simulated altitude
  • Core temperature
  • Occupational Heat Stress
  • Aging
  • Hypoxia
  • Hyperthermia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2026-07-14.