NCT07664462 Working in the Heat at Simulated Altitude: Effects of Normobaric Hypoxia on Physiological Strain
| NCT ID | NCT07664462 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ottawa |
| Condition | Body Temperature Changes |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-06-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-06-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Current occupational heat-stress guidelines aim to limit excessive increases in core body temperature and physiological strain through the use of work-rest schedules. However, these guidelines do not provide clear direction on the safe, maximum duration of continuous work that can be performed before heat-mitigation controls should be implemented, 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, but these estimates were developed under normoxic conditions. In many occupational settings, workers may be exposed to additional environmental stressors such as hypoxia, including work at altitude or in oxygen-reduced environments. Hypoxia can increase cardiovascular strain, reduce arterial oxygen saturation, and alter exercise tolerance, potentially compromising the effectiveness of heat-stress guidance developed under normal oxygen conditions. Older workers may be especially vulnerable due to age-related reductions in thermoregulatory and cardiovascular function. To date, it remains unclear whether hypoxia alters 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 exposure to hypoxia increases physiological strain during moderate-intensity work in the heat in young and older males. Specifically, investigators will assess whether normoxia-derived initial stay times and recovery recommendations for work at 29°C wet-bulb globe (37.5°C, 35% RH) temperature remain effective when workers are exposed to hypoxia equivalent to 14% inspired oxygen (simulating \~3000 m in altitude). Healthy young and older males will complete simulated occupational heat exposure under two conditions: heat alone and combined 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. Measures of core temperature, cardiovascular strain, oxygen saturation, skin temperature, hydration status, perceptual responses, mood, symptoms of environmental stress, and cognitive function will be assessed to determine whether hypoxia modifies responses to work in the heat. This study will provide important evidence on whether occupational heat-stress guidance requires refinement when workers are exposed to combined heat and hypoxic stress.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07664462 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 70 Years, studying Body Temperature Changes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07664462 currently recruiting?
Yes, NCT07664462 is actively recruiting participants. Contact the research team at gkenny@uottawa.ca for enrollment information.
Where is the NCT07664462 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT07664462 clinical trial?
NCT07664462 is sponsored by University of Ottawa. The trial plans to enroll 20 participants.