NCT06142890

Brief Summary

With the increasing regularity and intensity of hot weather and heat waves, there is an urgent need to develop heat-alleviation strategies able to provide targeted protection for heat-vulnerable older adults. While air-conditioning provides the most effective protection from extreme heat, it is inaccessible for many individuals. Air-conditioning is also energy intensive, which can strain the electrical grid and, depending on the source of electricity generation, contribute to green house gas emissions. For these reasons, recent guidance has recommended the use of electric fans as a sustainable cooling alternative. While fans may increase sweat evaporation and heat loss in healthy, young adults, evidence supporting their use in older adults is scarce. Further, studies show that when environmental temperature exceeds skin temperature, fans are not effective and can even exacerbate hyperthermia in older adults. While older adults only account for \~13% of the population, they account for \~40% off all hospitalizations. In the context of sustainable cooling interventions, this is of particular importance given that many hospitals and long-term care homes do not have air-conditioning and rely on ceiling fans to enhance sweat evaporation while participants are bed-resting. While recent biophysical modelling has suggested that pedestal fans likely provide a clinically meaningful cooling effect (proposed to be ≥0.3°C) in temperatures below \~34°C in older adults, the efficacy of ceiling fans in mitigating heat strain in these conditions is currently unknown. To address these knowledge gaps, this randomized crossover trial will evaluate body core temperature, cardiovascular strain, orthostatic intolerance, dehydration, and thermal comfort in adults aged 65-85 years exposed for 8-hours to conditions experienced during indoor overheating occurring during a heat wave in a temperate continental climate (31°C, 45% relative humidity). Each participant will complete two randomized exposures that will differ only in the airflow generated by a ceiling fan: no airflow (control) or standard airflow. Participants will remain in a supine position for the duration of the 8-hour exposure period, except for during hour 7 when they will complete a series of cardiovascular autonomic response tests.

Trial Health

87
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
Completed

Started Dec 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

November 13, 2023

Last Update Submit

February 17, 2025

Conditions

Keywords

Heat waveCooling interventionElderlyThermoregulationCardiovascular strainExtreme heat event

Outcome Measures

Primary Outcomes (1)

  • Core temperature (peak)

    Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout each simulated heat wave.

    End of heat exposure (hour 8)

Secondary Outcomes (18)

  • Core temperature (AUC)

    End of heat exposure (hour 8)

  • Core temperature (end-exposure)

    End of heat exposure (hour 8)

  • Heart rate (peak)

    End of heat exposure (hour 8)

  • Heart rate (end-exposure)

    End of heat exposure (hour 8)

  • Heart rate (AUC)

    End of heat exposure (hour 8)

  • +13 more secondary outcomes

Study Arms (2)

No cooling intervention (control)

ACTIVE COMPARATOR

Adults aged 65-85 years with or without type 2 diabetes and/or hypertension

Other: No cooling (control)

Ceiling fan generating airflow

EXPERIMENTAL

Adults aged 65-85 years with or without type 2 diabetes and/or hypertension

Other: Cooling with ceiling fan

Interventions

Participants are exposed to 31°C, 45% relative humidity for 8 hours without cooling intervention (control condition). Drinking water is available ad libitum. Participants remain in supine position with slight (\~20°) chest and head elevation (low-Fowlers position) throughout the duration of bed-rest exposure.

No cooling intervention (control)

Participants are exposed to 31°C, 45% relative humidity for 8 hours. Drinking water is available ad libitum. Participants remain in supine position with slight (\~20°) chest and head elevation (low-Fowlers position) throughout the duration of bed-rest exposure. Participants will remain under a commercially available ceiling fan generating a standard air flow throughout the duration of exposure.

Ceiling fan generating airflow

Eligibility Criteria

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

You may qualify if:

  • Male or female adults.
  • Aged 65-85 years.
  • Non-smoking.
  • English or French speaking.
  • Ability to provide informed consent.

You may not qualify if:

  • Physical restriction (e.g., due to disease: 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 (e.g., medications increasing risk of heat-related illness; beta blockers, anticholinergics, etc.)
  • Cardiac abnormalities identified via 12-lead ECG during an incremental exercise test to volitional fatigue (performed for all participants).
  • Peak aerobic capacity (VO2peak), as measured during an incremental exercise test to volitional fatigue, exceeding the 50th percentile of age- and sex-specific normative values published by the American College of Sports Medicine (ACSM).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

Related Publications (1)

  • O'Connor FK, Meade RD, Janetos KT, Li-Maloney C, Sigal RJ, Boulay P, Kenny GP. Effect of Ceiling Fans on Core Temperature in Bed-Resting Older Adults Exposed to Indoor Overheating. J Am Geriatr Soc. 2026 Jan;74(1):200-204. doi: 10.1111/jgs.70109. Epub 2025 Sep 27.

MeSH Terms

Conditions

HyperthermiaHeat Stress Disorders

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Glen P Kenny, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be informed of the study interventions before providing informed consent but will be masked to the order of the arms until exposure (i.e., participants will not know the fan conditions before entering the environmental chamber). Data will be blinded prior to analysis (including during statistical analysis).
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Each participant will complete 2 simulated heat wave exposures in random order: i) bed-rest; no fan cooling (control) and ii) bed-rest positioned beneath a ceiling fan providing standard air flow.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 22, 2023

Study Start

December 5, 2023

Primary Completion

February 10, 2024

Study Completion

February 10, 2024

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Deidentified participant data will be made available with approved analysis plan and signed access agreement

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Following publication of the main report(s)
Access Criteria
Approved analysis plan and signed access agreement

Locations