NCT07664462

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jun 2026Feb 2027

First Submitted

Initial submission to the registry

June 17, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

June 17, 2026

Last Update Submit

July 11, 2026

Conditions

Keywords

Heat StrainThermoregulationExerciseSimulated altitudeCore temperatureOccupational Heat StressAgingHypoxiaHyperthermia

Outcome Measures

Primary Outcomes (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.

    During the 240-minute work period

Secondary Outcomes (30)

  • Time to core temperature of 38.0°C

    During the 240-minute work period

  • Time to 1.0°C increase in core temperature

    During the 240-minute work period

  • Average core temperature during work/rest cycles

    During the 240-minute work period

  • Heart rate at core temperature of 38.0°C

    During the 240-minute work period

  • Heart rate at 1.0°C increase in core temperature

    During the 240-minute work period

  • +25 more secondary outcomes

Study Arms (2)

Normoxic exposure

EXPERIMENTAL

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.

Other: Simulated Occupational heat exposure under normoxic conditions

Hypoxic exposure

EXPERIMENTAL

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.

Other: Simulated Occupational heat exposure under hypoxic conditions

Interventions

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.

Normoxic exposure

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.

Hypoxic exposure

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

RECRUITING

MeSH Terms

Conditions

Body Temperature ChangesHeat Stress DisordersAltitude SicknessOccupational StressMotor ActivityHypoxiaHyperthermia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesRespiration DisordersRespiratory Tract DiseasesOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorSigns and Symptoms, Respiratory

Study Officials

  • Glen P Kenny, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Glen P Kenny, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, University Research Chair

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 24, 2026

Study Start

June 17, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

July 14, 2026

Record last verified: 2026-07

Locations