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Heat Waves and the Elderly - Cooling Modalities

Heat Waves in the Elderly: Reducing Thermal and Cardiovascular Consequences

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05484739
Enrollment
100
Registered
2022-08-02
Start date
2023-02-21
Completion date
2026-08-31
Last updated
2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Hyperthermia

Keywords

aging, heat wave, cardiovascular, low-energy cooling

Brief summary

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

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.

Interventions

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

OTHERFan

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

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

OTHERControl

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

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in core body temperatureBody core temperature will be obtained within 60 min before the heat wave exposure after the 3 hour heat wave exposure.Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer
Change in left ventricular functionWithin 60 minutes before each simulated heat wave exposure, around minute 90 of the heat wave exposure, and at the end of the 3 hour heat wave exposureMeasures of left ventricular function, such as ventricular wall motion and ventricular filling, will be obtained from echocardiography images.

Secondary

MeasureTime frameDescription
Arterial blood pressurePrior to and throughout each simulated heat wave exposure; an average of 480 minutesArterial blood pressure will be measured using a standard arm blood pressure cuff.
Whole body sweat rateWithin 60 minutes before each simulated heat wave exposure and within 30 minutes after each heat wave exposure.Whole body sweat rate will be measured by through nude weight of the participant.
Markers of renal function and injury - Cystatin CWithin 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposureMarkers of renal function and injury (e.g., cystatin C) will be evaluated from blood sampling collection.
Markers of renal function and injury - Creatinine ClearanceWithin 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposureMarkers of renal function and injury (e.g., creatinine clearance) will be evaluated from blood sampling and urine collection.
Markers of renal function and injury - Insulin-like growth factor-binding protein 7Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposureMarkers of renal function and injury (e.g., Insulin-like growth factor-binding protein 7) will be evaluated from urine sampling.
Heart ratePrior to and throughout each simulated heat wave exposure; approximately 420 minutesHeart rate will be measured from ECG electrodes attached to the participant
Cerebral perfusionWithin 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)Cerebral perfusion will be measured by Doppler ultrasound of the internal carotid and vertebral arteries.
High sensitive cardiac troponinWithin 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposureA plasma-based marker of cardiac stress (high sensitive cardiac troponin) be evaluated from blood sampling.
Skin temperatureWithin 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin
Forced vital capacity (FVC)Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)Forced vital capacity will be obtained from spirometry
Markers of renal function and injury - Tissue inhibitor of metalloproteinases 2Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposureMarkers of renal function and injury (e.g., Tissue inhibitor of metalloproteinases 2) will be evaluated from urine sampling.
Cardiac outputWithin 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)Cardiac output (how much blood is ejected from the heart) will be measured using 3D echocardiography.

Countries

United States

Contacts

Primary ContactRachel Cottle, PhD
RachelCottle@texashealth.org214-345-6557
Backup ContactErin Harper, BS
ErinHarper@texashealth.org214-345-5022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026