NCT07656519

Brief Summary

Extreme heat events are becoming more frequent, intense, and prolonged, increasing the risk of heat-related illness among workers exposed to hot environments. Current occupational heat-stress guidelines are designed to limit excessive increases in core body temperature and physiological strain during work in the heat through the use of work-rest schedules. However, these guidelines are largely based on single-day heat exposures and assume that workers recover in cool indoor environments between shifts. During heat events, many workers may instead recover in homes or accommodations that remain overheated, particularly in the absence of air conditioning. Inadequate overnight cooling may impair the body's ability to dissipate heat, increase physiological strain, and reduce tolerance to heat exposure on subsequent workdays. Older adults may be especially vulnerable due to age-related impairments in heat-loss capacity. To date, the effects of recovering in an overheated indoor environment on physiological strain and thermoregulatory function during repeated occupational heat exposure remain poorly understood, limiting the development of evidence-based recommendations to protect workers during prolonged heat events. The primary objective of this study is to determine whether overnight recovery in an overheated indoor environment increases physiological strain during repeated occupational heat exposure in older adults. Specifically, investigators will assess whether recovery at the recently proposed upper indoor temperature limit of 26°C and 45% relative humidity (RH) (PMID: 38329752) is sufficient to attenuate elevations in core temperature during subsequent work in the heat compared with recovery in an overheated indoor environment (31°C, 45% RH) representative of conditions commonly experienced during extreme heat events. Healthy older adults will complete two consecutive days and nights of simulated moderate-intensity occupational heat exposure, with overnight recovery occurring in either the 26°C or 31°C condition. Measures of core temperature, cardiovascular strain, heat-loss capacity, hydration status, sleep quality, cognitive function, mood, and perceptual responses will be assessed to determine the impact of overnight recovery conditions on responses to repeated heat exposure. Whole-body heat-loss capacity will also be evaluated before and after the exposure protocol as assessed during incremental, intermittent exercise protocol performed in an air calorimeter.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jul 2026Aug 2027

First Submitted

Initial submission to the registry

June 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

June 9, 2026

Last Update Submit

June 14, 2026

Conditions

Keywords

Heat StrainThermoregulationExerciseCore temperatureOccupational heat stressAgingHeat waveSleepHyperthermia

Outcome Measures

Primary Outcomes (1)

  • Total work volume.

    Total work completed during the 240-minute work protocol performed in the morning and afternoon work periods, expressed as cumulative minutes of work performed over the two consecutive work days. The work period consists of an initial continuous walking phase to a core temperature 38.0°C or 1°C increase above baseline resting (as measured prior to the start of the 2-day work protocol), followed by intermittent work-rest cycles. The morning and afternoon work periods are separated by a 1-hour recovery period.

    During each 240-minute morning and afternoon work bout on Day 1 and Day 2.

Secondary Outcomes (44)

  • Time to core temperature of 38.0°C

    During each 240-minute morning and afternoon work bout on Day 1 and Day 2.

  • Time to 1.0°C increase in rectal temperature

    During each 240-minute morning and afternoon work bout on Day 1 and Day 2.

  • Average core temperature during work/rest cycles

    During each 240-minute morning and afternoon work bout on Day 1 and Day 2.

  • Heart rate at core temperature of 38.0°C

    Each morning and afternoon work bout on Day 1 and Day 2.

  • Heart rate at 1.0°C increase in core temperature

    Each morning and afternoon work bout on Day 1 and Day 2.

  • +39 more secondary outcomes

Study Arms (2)

Recovery at recommended indoor temperature limit

EXPERIMENTAL

Participants complete a 2-day, 2-night simulated occupational heat exposure protocol consisting of daytime work in a hot environment (37.5°C, 35% RH) and overnight recovery (18:30-08:00) at the recommended upper indoor temperature limit (26°C, 45% RH).

Other: Simulated occupational heat exposure with recovery at recommended indoor temperature limit

Recovery in an overheated indoor environment

EXPERIMENTAL

Participants complete a 2-day, 2-night simulated occupational heat exposure protocol consisting of daytime work in a hot environment (37.5°C, 35% RH) and overnight recovery (18:30-08:00) in an overheated indoor environment (31°C, 45% RH).

Other: Simulated occupational heat exposure with recovery in an overheated indoor environment

Interventions

Participants complete a 2-day, 2-night simulated occupational heat exposure protocol involving daytime work in a hot environment (37.5°C, 35% RH) and overnight recovery (18:30-08:00) at the recommended upper indoor temperature limit (26°C, 45% RH).

Recovery at recommended indoor temperature limit

Participants complete a 2-day, 2-night simulated occupational heat exposure protocol involving daytime work in a hot environment (37.5°C, 35% RH) and overnight recovery (18:30-08:00) in an overheated indoor environment (31°C, 45% RH).

Recovery in an overheated indoor environment

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersYes
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)
  • 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

Location

Related Publications (1)

  • Meade RD, Akerman AP, Notley SR, Kirby NV, Sigal RJ, Kenny GP. Effects of Daylong Exposure to Indoor Overheating on Thermal and Cardiovascular Strain in Older Adults: A Randomized Crossover Trial. Environ Health Perspect. 2024 Feb;132(2):27003. doi: 10.1289/EHP13159. Epub 2024 Feb 8.

    PMID: 38329752BACKGROUND

MeSH Terms

Conditions

Body Temperature ChangesHeat Stress DisordersOccupational StressMotor ActivityHyperthermia

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

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 9, 2026

First Posted

June 18, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

June 18, 2026

Record last verified: 2026-06

Locations