COPDNCT06295523
Heat Waves and the Elderly With COPD
A study testing Water Spray in people with COPD and Aging, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COPD, Aging, Hyperthermia
- What is being tested?
- Water Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years old or older
- Diagnosis of COPD
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
- Participant with a body mass index ≥31 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
About this study
Official title: Heat Waves and the Elderly With COPD: Reducing Thermal and Cardiovascular Consequences
The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD.
Read the detailed description
Heat waves are the leading cause of death among natural disasters in the United States.
Elderly individuals are disproportionately more likely to become ill or die during heat waves. While the elderly have a reduced ability to regulate their body temperature,8-10 hospitalizations and deaths in this population during heat waves are primarily due to cardiovascular and/or respiratory complications, not solely hyperthermia. While previous research has primarily focused on the thermal and cardiovascular consequences of healthy aging, very little research has focused on the physiological responses to heat exposure in older individuals with chronic disease, such as chronic obstructive pulmonary disease (COPD). Notably, epidemiological data suggests that pulmonary complications are a leading cause of heat wave-related hospitalizations in older adults with a diagnosis of COPD, yet nothing is known regarding the physiological mechanisms by which those with COPD are most susceptible to heat waves. To fill this important gap, the investigators will identify the physiological responses that occur in this population, relative to healthy age-matched individuals, during two unique heat wave simulations.
- Conditions
- COPD, Aging, Hyperthermia
- Being tested
- Water Spray, Control
- Keywords
- COPD, heat wave, thermoregulation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, 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.
ControlOther
Participants will NOT receive water spraying on their body throughout the climate exposure.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 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. Two visits will be required to complete this arm, with one visit including water spray for cooling. Receives: Other: Water Spray; Other: Control |
| Experimental: 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. Two visits will be required to complete this arm, with one visit including water spray for cooling. Receives: Other: Water Spray; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core body temperature
Core body temperature will be measure from gastrointestinal temperature via an ingestible telemetric pill
Measured: Prior to and throughout each simulated heat wave exposure, an average of 480 minutes
Forced expiratory volume (FEV1)
FEV1 will be assessed via spirometry
Measured: Prior to, during, and after each simulated heat wave exposure, approximately 10 min each
Forced vital capacity (FVC)
FVC will be assessed via spirometry
Measured: Prior to, during, and after each simulated heat wave exposure, approximately 10 min each
FEV1/FVC ratio
The ratio of forced expiratory volume and forced vital capacity will be assessed via spirometry
Measured: Prior to, during, and after each simulated heat wave exposure, approximately 10 min each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Jan 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Why it stopped: Study terminated due to recruitment challenges coupled with our focus changing to a different direction.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295523
- Sponsor's protocol ID
- STU_2019_1759_COPD
- Status last verified
- Oct 2025
- First submitted
- 26 Feb 2024
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Waves and the Elderly With COPD: Reducing Thermal and Cardiovascular Consequences
- ClinicalTrials.gov ID
- NCT06295523
- Acronym / sponsor ID
- STU_2019_1759_COPD
- Conditions
- COPD, Aging, Hyperthermia
- Keywords
- COPD, heat wave, thermoregulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to recruitment challenges coupled with our focus changing to a different direction.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 6 Mar 2024 (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 investigate thermoregulatory responses in older individuals with COPD.
Detailed description
Heat waves are the leading cause of death among natural disasters in the United States.
Elderly individuals are disproportionately more likely to become ill or die during heat waves. While the elderly have a reduced ability to regulate their body temperature,8-10 hospitalizations and deaths in this population during heat waves are primarily due to cardiovascular and/or respiratory complications, not solely hyperthermia. While previous research has primarily focused on the thermal and cardiovascular consequences of healthy aging, very little research has focused on the physiological responses to heat exposure in older individuals with chronic disease, such as chronic obstructive pulmonary disease (COPD). Notably, epidemiological data suggests that pulmonary complications are a leading cause of heat wave-related hospitalizations in older adults with a diagnosis of COPD, yet nothing is known regarding the physiological mechanisms by which those with COPD are most susceptible to heat waves. To fill this important gap, the investigators will identify the physiological responses that occur in this population, relative to healthy age-matched individuals, during two unique heat wave simulations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Very hot and dry | Experimental | Other: Water Spray, 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. Two visits will be required to complete this arm, with one visit including water spray for cooling. |
| Experimental: Hot and humid | Experimental | Other: Water Spray, 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. Two visits will be required to complete this arm, with one visit including water spray for cooling. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years old or older
- Diagnosis of COPD
Key exclusion criteria (5 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
- Participant 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 | Experimental: Hot and humid, Experimental: Very hot and dry |
| ControlParticipants will NOT receive water spraying on their body throughout the climate exposure. | Other | Experimental: Hot and humid, Experimental: Very hot and dry |
Primary outcome
Core body temperature
Time frame: Prior to and throughout each simulated heat wave exposure, an average of 480 minutes
Core body temperature will be measure from gastrointestinal temperature via an ingestible telemetric pill
Forced expiratory volume (FEV1)
Time frame: Prior to, during, and after each simulated heat wave exposure, approximately 10 min each
FEV1 will be assessed via spirometry
Forced vital capacity (FVC)
Time frame: Prior to, during, and after each simulated heat wave exposure, approximately 10 min each
FVC will be assessed via spirometry
FEV1/FVC ratio
Time frame: Prior to, during, and after each simulated heat wave exposure, approximately 10 min each
The ratio of forced expiratory volume and forced vital capacity will be assessed via spirometry
Results and safety
The study was stopped early (reason given: Study terminated due to recruitment challenges coupled with our focus changing to a different direction.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with COPD and Aging, 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 5 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: stopped early, as of the sponsor's last update on 24 Oct 2025. 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?
The study was stopped early (reason given: Study terminated due to recruitment challenges coupled with our focus changing to a different direction.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core body temperature (time frame: Prior to and throughout each simulated heat wave exposure, an average of 480 minutes). The study lists 4 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 24 Oct 2025; AzTrials last refreshed its copy on 27 Oct 2026.