Heat Waves and the Elderly - Cooling Modalities

NCT ID: NCT05484739

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-21

Study Completion Date

2026-08-31

Brief Summary

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The purpose of this study is to assess how well cooling modalities work in reducing cardiovascular stress of the elderly to heat wave conditions

Detailed Description

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Heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. Such deaths are primarily cardiovascular, not hyperthermia itself, in origin. The central hypothesis of this work is that cardiovascular stress during heat wave conditions in the elderly can be reduced by applying low-energy cooling modalities. Comprehensive cardiovascular and thermal responses in the elderly will be evaluated during exposure to two prolonged heat wave conditions: hot and humid (replicating the 1995 Chicago heat wave), very hot and dry (replicating the 2018 Los Angeles heat wave). With each of these heat wave conditions individuals will be exposed to the following cooling modalities: no cooling (control), water spray, fan use, and fan use plus water spray.

Conditions

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Aging Hyperthermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The investigators will conduct a randomized crossover design study. Older individuals will be exposed to one of two heat wave conditions (Very hot and dry or hot and humid). For each heat wave condition the individual will receive one of the following cooling strategies, with each cooling strategy applied on a different day: A) a control trial, B) skin wetting only trial, C) fan only trial, and D) a combination of skin wetting with a fan trial. Thus, to complete the trial for a selected heat wave condition (e.g., either very hot and dry or hot and humid) four experimental visits will be required - one visit for each cooling strategy.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Very hot and dry

Subjects will be exposed to 3 hours in a climate chamber set to approximately 47 deg C and 15% relative humidity, which reflects a very hot and dry heat wave condition similar to the 2018 Los Angeles heat wave. Four visits will be required to complete this arm, with each visit a different cooling modality applied.

Group Type EXPERIMENTAL

Water Spray

Intervention Type OTHER

Participants will receive water spraying on their body throughout the climate chamber exposure.

Fan

Intervention Type OTHER

Participants will be exposed to a fan throughout the climate chamber exposure.

Water Spray and Fan

Intervention Type OTHER

Participants will receive both water spraying and a fan throughout the climate chamber exposure.

Control

Intervention Type OTHER

Participants will NOT receive either water spray or a fan exposure.

Hot and humid

Subjects will be exposed to 3 hours in a climate chamber set to approximately 41 deg C and 40% relative humidity, which reflects hot and humid heat wave similar to the 1995 Chicago heat wave. Four visits will be required to complete this arm, with each visit a different cooling modality applied.

Group Type EXPERIMENTAL

Water Spray

Intervention Type OTHER

Participants will receive water spraying on their body throughout the climate chamber exposure.

Fan

Intervention Type OTHER

Participants will be exposed to a fan throughout the climate chamber exposure.

Water Spray and Fan

Intervention Type OTHER

Participants will receive both water spraying and a fan throughout the climate chamber exposure.

Control

Intervention Type OTHER

Participants will NOT receive either water spray or a fan exposure.

Interventions

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Water Spray

Participants will receive water spraying on their body throughout the climate chamber exposure.

Intervention Type OTHER

Fan

Participants will be exposed to a fan throughout the climate chamber exposure.

Intervention Type OTHER

Water Spray and Fan

Participants will receive both water spraying and a fan throughout the climate chamber exposure.

Intervention Type OTHER

Control

Participants will NOT receive either water spray or a fan exposure.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 65 years of age or older
* Free of any significant underlying medical problems based upon a detailed medical history and physical exam

Exclusion Criteria

* Known heart disease
* Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia etc;
* Abnormality detected on routine screening suggestive of provokable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Subject with a body mass index ≥31 kg/m2
* Pregnant individuals
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Craig Crandall

Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Texas Health Presbyterian Hospital Dallas

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rachel Cottle, PhD

Role: CONTACT

214-345-6557

Erin Harper, BS

Role: CONTACT

214-345-5022

Facility Contacts

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Zachary McKenna, PhD

Role: primary

214-345-6557

Taysom Wallace, MS

Role: backup

214.345.5022

Other Identifiers

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STU-2022-0625

Identifier Type: -

Identifier Source: org_study_id

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