ClinicalTrials.gg
RecruitingNCT05484739Updated Sep 8, 2026

Heat Waves and the Elderly - Cooling Modalities

An interventional study of Water Spray and Fan in Aging and Hyperthermia, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Aging
  • Hyperthermia

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Keywords

  • aging
  • heat wave
  • cardiovascular
  • low-energy cooling
03

In context

Hyperthermia

256 studies on the registry are indexed under Hyperthermia; 73 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 232 interventional studies indexed under Hyperthermia.

Browse Hyperthermia studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
  • Current smokers, as well as individuals who regularly smoked within the past 3 years
  • Subject with a ≥31 kg/m2
  • Pregnant individuals
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Water Spray · Other: Fan · Other: Water Spray and Fan · Other: Control

  • Experimental
    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.

    Other: Water Spray · Other: Fan · Other: Water Spray and Fan · Other: Control

Interventions

  • OtherWater Spray

    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.

  • OtherWater Spray and Fan

    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.

06

What researchers measure

Primary outcomes

  1. Change in core body temperature

    Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer

    Time frame: Body core temperature will be obtained within 60 min before the heat wave exposure after the 3 hour heat wave exposure.

  2. Change in left ventricular function

    Measures of left ventricular function, such as ventricular wall motion and ventricular filling, will be obtained from echocardiography images.

    Time frame: Within 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 exposure

Secondary outcomes

  1. Heart rate

    Heart rate will be measured from ECG electrodes attached to the participant

    Time frame: Prior to and throughout each simulated heat wave exposure; approximately 420 minutes

  2. Cardiac output

    Cardiac output (how much blood is ejected from the heart) will be measured using 3D echocardiography.

    Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)

  3. Arterial blood pressure

    Arterial blood pressure will be measured using a standard arm blood pressure cuff.

    Time frame: Prior to and throughout each simulated heat wave exposure; an average of 480 minutes

  4. Whole body sweat rate

    Whole body sweat rate will be measured by through nude weight of the participant.

    Time frame: Within 60 minutes before each simulated heat wave exposure and within 30 minutes after each heat wave exposure.

  5. Markers of renal function and injury - Cystatin C

    Markers of renal function and injury (e.g., cystatin C) will be evaluated from blood sampling collection.

    Time frame: Within 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 exposure

  6. Markers of renal function and injury - Creatinine Clearance

    Markers of renal function and injury (e.g., creatinine clearance) will be evaluated from blood sampling and urine collection.

    Time frame: Within 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 exposure

  7. Markers of renal function and injury - Insulin-like growth factor-binding protein 7

    Markers of renal function and injury (e.g., Insulin-like growth factor-binding protein 7) will be evaluated from urine sampling.

    Time frame: Within 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 exposure

  8. Markers of renal function and injury - Tissue inhibitor of metalloproteinases 2

    Markers of renal function and injury (e.g., Tissue inhibitor of metalloproteinases 2) will be evaluated from urine sampling.

    Time frame: Within 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 exposure

  9. Cerebral perfusion

    Cerebral perfusion will be measured by Doppler ultrasound of the internal carotid and vertebral arteries.

    Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)

  10. High sensitive cardiac troponin

    A plasma-based marker of cardiac stress (high sensitive cardiac troponin) be evaluated from blood sampling.

    Time frame: Within 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 exposure

  11. Skin temperature

    Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin

    Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)

  12. Forced vital capacity (FVC)

    Forced vital capacity will be obtained from spirometry

    Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Jan 2027, 47 months after the start.

Of 103 non-industry interventional studies with no phase under Hyperthermia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 47 months is above that.

Counting every sponsor, half of 108 studies reached it within 18 months; a quarter within 7 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2022
First posted
Aug 2, 2022
StartActual
Feb 21, 2023
Primary completionEst.
Jan 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05484739
Responsible party
Craig Crandall (Professor of Internal Medicine, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Aug 2, 2022
Start date
Feb 21, 2023
Primary completion
Jan 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Rachel Cottle, PhD
Contact
RachelCottle@texashealth.org
214-345-6557
Erin Harper, BS
Contact
ErinHarper@texashealth.org
214-345-5022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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