NCT06633302

Brief Summary

A recent report showed that maintaining indoor temperature at or below 26°C safeguards older, heat vulnerable adults against potentially dangerous increases in thermal and cardiovascular strain during an extreme heat event (PMID: 38329752). However, this proposed limit does not consider the potential cumulative effect of successive days of heat exposure, which could lead to a progressive deterioration in thermoregulatory and cardiovascular function and necessitate adjustments to upper indoor temperature limits. Further, thermal comfort and quality of sleep may be negatively impacted when bedroom temperatures exceed 24°C (PMID: 3090680). On this basis, some health agencies have recommended that bedroom temperatures at night should not exceed 26°C unless ceiling fans are available (PMID: 3090680). Currently, however, it is unknown whether indoor overheating impairs sleep quality and physiological strain on a subsequent day in older adults and, if so, whether maintaining indoor temperature at 26°C is sufficient to prevent these adverse health impacts. With rising global temperatures and more extreme heat events, energy management strategies to limit the strain on the power grid during the daytime are now increasingly commonplace. Thus, understanding the benefits of maintaining indoor temperature at the recommend upper limits of 26°C during the nighttime only on surrogate physiological indicators of health is an important step in understanding how to optimize protection for heat-vulnerable older adults when power outages occur. The investigators will assess the efficacy of proposed indoor temperature limits (i.e., 26°C) in mitigating increases in core temperature and cardiovascular strain over three consecutive days (3 days, 2 nights) in older adults (60-85 years) with (indoor temperatures maintained at the recommend 26°C at all times throughout the three days) and without (daytime temperature fixed at 34°C (temperature experienced in homes without air-conditioning during an extreme heat event) with nighttime temperature at 26°C) access to daytime cooling. By quantifying the effect of daylong indoor overheating on surrogate physiological outcomes linked with heat-related mortality and morbidity in older adults, the investigators can determine if refinements in the recommended upper temperature threshold is required, including best practices when power outages may occur during an extreme heat event.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

October 4, 2024

Last Update Submit

March 23, 2026

Conditions

Keywords

Heat waveIndoor overheatingIndoor temperaturesThermoregulationHeat strainElderlyHeat vulnerabilityCardiovascular strainSleepHyperthermiaFatigue

Outcome Measures

Primary Outcomes (1)

  • Core temperature (Peak) during daytime

    Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout the daytime period of the simulated heat wave.

    End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

Secondary Outcomes (37)

  • Muscle oxygen during battery of cardiovascular, postural and cognitive tests during daytime

    End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

  • Profiles of Mood States (POMS) during daytime

    End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

  • Heart rate variability: RMSSD during nighttime

    End of nighttime exposure (hour 24 for Day 1 and Day 2 of the three day exposure; no nighttime exposure for Day 3) (daytime defined as period between 19:00 to 9:00)

  • Heart rate variability: SDNN during nighttime

    End of nighttime exposure (hour 24 for Day 1 and Day 2 of the three day exposure; no nighttime exposure for Day 3) (daytime defined as period between 19:00 to 9:00)

  • Heat rate AUC during nighttime

    End of nighttime exposure (hour 24 for Day 1 and Day 2 of the three day exposure; no nighttime exposure for Day 3) (daytime defined as period between 19:00 to 9:00)

  • +32 more secondary outcomes

Study Arms (2)

Exposure to indoor temperature limits daylong

EXPERIMENTAL

Participants exposed to three consecutive days (3 days, 2 nights) in an indoor environment maintained at either 26°C at all times (condition A, recommended upper indoor temperature limits during an extreme heat event).

Other: Simulated multi-day heatwave exposure

Exposure to indoor temperature limits nighttime only

EXPERIMENTAL

Participants exposed to three consecutive days (3 days, 2 nights) to indoor overheating during the daytime (34°C, temperatures experienced in homes without air-conditioning) (9:00 to 19:00) with nighttime (19:00 to 9:00) indoor temperatures reduced to the recommended limit of 26°C.

Other: Simulated multi-day heatwave exposure

Interventions

Older adults exposed to a multi-day simulated heat wave exposure

Exposure to indoor temperature limits daylongExposure to indoor temperature limits nighttime only

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Non-smoking.
  • English or French speaking.
  • Ability to provide informed consent.
  • with or without a) chronic hypertension (elevated resting blood pressure; as defined by Heart and Stroke Canada and Hypertension Canada), b) type 2 diabetes as defined by Diabetes Canada, with at least 5 years having elapsed since time of diagnosis

You may not qualify if:

  • 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 your 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, K1N1A2, Canada

Location

MeSH Terms

Conditions

Heat Stress DisordersHyperthermiaFatigue

Condition Hierarchy (Ancestors)

Wounds and InjuriesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

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
Professor

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 9, 2024

Study Start

October 15, 2024

Primary Completion

May 21, 2025

Study Completion

May 21, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations