AgingNCT05484739
Heat Waves and the Elderly - Cooling Modalities
A study testing Water Spray, Fan and Water Spray and Fan in people with Aging and Hyperthermia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Hyperthermia
- What is being tested?
- Water Spray, Fan and Water Spray and Fan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age or older
- Free of any significant underlying medical problems based upon a detailed medical history and physical exam
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
Zachary McKenna, PhD, 214-345-6557, ZacharyMckenna@texashealth.org
Taysom Wallace, MS, 214.345.5022, TaysomWallace@texashealth.org
About this study
Official title: Heat Waves in the Elderly: Reducing Thermal and Cardiovascular Consequences
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.
- Conditions
- Aging, Hyperthermia
- Being tested
- Water Spray, Fan, Water Spray and Fan, Control
- Keywords
- aging, heat wave, cardiovascular, low-energy cooling
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water SprayOther
Participants will receive water spraying on their body throughout the climate chamber exposure.
FanOther
Participants will be exposed to a fan throughout the climate chamber exposure.
Water Spray and FanOther
Participants will receive both water spraying and a fan throughout the climate chamber exposure.
ControlOther
Participants will NOT receive either water spray or a fan exposure.
| Study group | Role | What they receive |
|---|---|---|
| Very hot and dry | Experimental | 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. Receives: Other: Water Spray; Other: Fan; Other: Water Spray and Fan; Other: Control |
| Hot and humid | Experimental | 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. Receives: Other: Water Spray; Other: Fan; Other: Water Spray and Fan; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in core body temperature
Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer
Measured: Body core temperature will be obtained within 60 min before the heat wave exposure after the 3 hour heat wave exposure.
Change in left ventricular function
Measures of left ventricular function, such as ventricular wall motion and ventricular filling, will be obtained from echocardiography images.
Measured: 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 (12)
Heart rate
Heart rate will be measured from ECG electrodes attached to the participant
Measured: Prior to and throughout each simulated heat wave exposure; approximately 420 minutes
Cardiac output
Cardiac output (how much blood is ejected from the heart) will be measured using 3D echocardiography.
Measured: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)
Arterial blood pressure
Arterial blood pressure will be measured using a standard arm blood pressure cuff.
Measured: Prior to and throughout each simulated heat wave exposure; an average of 480 minutes
Whole body sweat rate
Whole body sweat rate will be measured by through nude weight of the participant.
Measured: Within 60 minutes before each simulated heat wave exposure and within 30 minutes after each heat wave exposure.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Cerebral perfusion
Cerebral perfusion will be measured by Doppler ultrasound of the internal carotid and vertebral arteries.
Measured: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)
High sensitive cardiac troponin
A plasma-based marker of cardiac stress (high sensitive cardiac troponin) be evaluated from blood sampling.
Measured: 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
Skin temperature
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin
Measured: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)
Forced vital capacity (FVC)
Forced vital capacity will be obtained from spirometry
Measured: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start21 Feb 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484739
- Sponsor's protocol ID
- STU-2022-0625
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Waves in the Elderly: Reducing Thermal and Cardiovascular Consequences
- ClinicalTrials.gov ID
- NCT05484739
- Acronym / sponsor ID
- STU-2022-0625
- Conditions
- Aging, Hyperthermia
- Keywords
- aging, heat wave, cardiovascular, low-energy cooling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Very hot and dry | Experimental | Other: Water Spray, Other: Fan, Other: Water Spray and Fan, Other: ControlSubjects 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. |
| Hot and humid | Experimental | Other: Water Spray, Other: Fan, Other: Water Spray and Fan, Other: ControlSubjects 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years of age or older
- Free of any significant underlying medical problems based upon a detailed medical history and physical exam
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water SprayParticipants will receive water spraying on their body throughout the climate chamber exposure. | Other | Hot and humid, Very hot and dry |
| FanParticipants will be exposed to a fan throughout the climate chamber exposure. | Other | Hot and humid, Very hot and dry |
| Water Spray and FanParticipants will receive both water spraying and a fan throughout the climate chamber exposure. | Other | Hot and humid, Very hot and dry |
| ControlParticipants will NOT receive either water spray or a fan exposure. | Other | Hot and humid, Very hot and dry |
Primary outcome
Change in core body temperature
Time frame: Body 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 function
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
Measures of left ventricular function, such as ventricular wall motion and ventricular filling, will be obtained from echocardiography images.
12 secondary outcomes
Heart rate
Time frame: Prior to and throughout each simulated heat wave exposure; approximately 420 minutes
Cardiac output
Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)
Arterial blood pressure
Time frame: Prior to and throughout each simulated heat wave exposure; an average of 480 minutes
Whole body sweat rate
Time frame: Within 60 minutes before each simulated heat wave exposure and within 30 minutes after each heat wave exposure.
Markers of renal function and injury - Cystatin C
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
Markers of renal function and injury - Creatinine Clearance
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
Markers of renal function and injury - Insulin-like growth factor-binding protein 7
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
Markers of renal function and injury - Tissue inhibitor of metalloproteinases 2
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
Cerebral perfusion
Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)
High sensitive cardiac troponin
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
Skin temperature
Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)
Forced vital capacity (FVC)
Time frame: Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Spray, Fan and Water Spray and Fan in people with Aging and Hyperthermia, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Cottle, PhD (214-345-6557, RachelCottle@texashealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in core body temperature (time frame: Body core temperature will be obtained within 60 min before the heat wave exposure after the 3 hour heat wave exposure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.