Heat StressNCT06979258
Heat Stress Exposure Among Low-Income Residents in Bangladesh and Evaluation of Indoor Interventions
A study testing Cooling intervention in people with Heat Stress, run by University of California, Berkeley at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to learn if infrastructure and equipment installed to cool homes reduce adverse health outcomes. The main questions it aims to answer are: What is the impact of the intervention on indoor heat stress? What is the impact of the intervention on personal exposure to heat stress? What is… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heat Stress
- What is being tested?
- Cooling intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,539 participants
- Where
- 1 siteBangladesh
- Study dates
- 12 May 2025to 31 Mar 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- House is located in an informal settlement in an urban area in Bangladesh
- The house has a corrugated iron roof and corrugated iron walls
- The household plans to remain in the house from Feb-Nov
- Lives in an eligible household
Who cannot join
- There is an inhabited structure about the house
- The landlord does not allow the proposed intervention
- Has access to air conditioning in their home or place of work
- Reports they are pregnant
- Has hypertension, as measured by study staff
- Has diabetes, as measured by study staff
- Self-reports cardiovascular disease / chronic cardiac condition
- Self-reports respiratory disease / chronic respiratory condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Dhaka Division, 1212
Nuhu Amin, BDS, +8802222277001 ext. 4023, nuhu.amin@icddrb.org
Nuhu Amin, BDS
About this study
Official title: Heat Stress: Exposure Among Low-Income Residents in Bangladesh and Evaluation of Indoor Interventions
The goal of this clinical trial is to learn if infrastructure and equipment installed to cool homes reduce adverse health outcomes. The main questions it aims to answer are:
What is the impact of the intervention on indoor heat stress? What is the impact of the intervention on personal exposure to heat stress? What is the impact of the intervention on health outcomes, including heart rate, and heart rate variability, and sleep quality?
Participants will have cooling infrastructure and/or equipment installed in their home; have heat stress sensors installed inside and outside their home and wear personal heat stress monitors; allow some biological functions such as heat rate, heat rate variability, and sleep quality.
Read the detailed description
During the last two decades, nearly half a million people died each year from heat-related causes; climate change is expected to exacerbate the burden of adverse health outcomes. Heat stress has been associated with an increase in all-cause mortality, cardiovascular disease and mortality, chronic respiratory disease, lower respiratory infection, chronic kidney disease, diabetes, adverse pregnancy outcomes, and poor mental health. The investigators will to determine personal heat stress of low-income individuals who do not have access to air conditioning, evaluate the effectiveness, acceptability, feasibility, and scalability of building-level cooling strategies to reduce indoor heat stress among vulnerable individuals, and evaluate the impact of these interventions on heart rate. A disproportionate burden of heat-related death and disease is borne by low-income communities because they do not have access to cooling and suffer from comorbidities that exacerbate the adverse impacts of heat stress. South Asia faces the greatest current and predicted loss in disability-adjusted life years due to heat stress, and heat stress is particularly strong in informal settlements. As such, the investigators plan to conduct this study in informal settlements in Dhaka, Bangladesh. The overall hypothesis is that individuals who live in homes with corrugated iron roofs and walls are at elevated risk of heat stress and that it is possible to modify homes to prevent increases in heart rate associated with heat stress, ultimately reducing cardiovascular morbidity and mortality. The investigators will evaluate the impact of cooling infrastructure and/or equipment interventions on residents' heart rate (primary outcome), heart rate variability, sleep quality, self-reported thermal comfort, mental health, wellness, fatigue, and indoor thermal conditions (secondary outcomes).
- Conditions
- Heat Stress
- Being tested
- Cooling intervention
- Keywords
- heat stress, cooling, heart rate, heart rate variability, sleep quality, Bangladesh
- Medical subject headings
- Heat Stress Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling interventionOther
Infrastructure and/or equipment that cools the house in the hot season
| Study group | Role | What they receive |
|---|---|---|
| Indoor cooling intervention | Experimental | Households in this arm will receive infrastructure and/or equipment intended to cool the house in the hot season. Receives: Other: Cooling intervention |
| Control | No intervention | Households in this arm will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
resting heart rate (beats per minute, bpm), where lower heart rate is better
Measured: 0, 2, and 4 weeks
Secondary outcomes (6)
Heart rate variability
resting heart rate (beats per minute, bpm) variability, where higher variability is better
Measured: 0, 2, and 4 weeks
Sleep quality
Self-reported sleep quality and number of minutes in rapid eye movement (REM), as recorded by a fitness watch, where more time in REM is better
Measured: 0, 2, and 4 weeks
Irritability
Self-reported irritability, as measured by the Brief Irritability Test (BITe), where a lower score is better
Measured: 0, 2, and 4 weeks
Environmental Symptoms
Environmental symptoms, as measured by the abbreviated environmental symptoms questionnaire, where a lower score is better
Measured: 0, 2, and 4 weeks
Depression
Depression as measured by the Patient Health Questionnaire version with 8 questions (PHQ-8). A total PHQ-8 score of >=7 indicated depression, >= 10 indicates major depression and >= 20 indicates severe depression.
Measured: 0, 2, and 4 weeks
Anxiety
Anxiety, as measured by the Generalised Anxiety Disorder with 7 questions (GAD-7). A total GAD-7 score of >= 8 indicates anxiety.
Measured: 0, 2, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start12 May 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StressStudies 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
- Single group
- Model description
- Stepped-wedge randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,539 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Laura H Kwong, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979258
- Sponsor's protocol ID
- 2024-08-17719
- Other IDs
- 1R01ES035910
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be stored in icddrb's data repository
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Stress: Exposure Among Low-Income Residents in Bangladesh and Evaluation of Indoor Interventions
- ClinicalTrials.gov ID
- NCT06979258
- Acronym / sponsor ID
- 2024-08-17719
- Conditions
- Heat Stress
- Keywords
- heat stress, cooling, heart rate, heart rate variability, sleep quality, Bangladesh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,539 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 12 May 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 18 May 2025 (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 goal of this clinical trial is to learn if infrastructure and equipment installed to cool homes reduce adverse health outcomes. The main questions it aims to answer are:
What is the impact of the intervention on indoor heat stress? What is the impact of the intervention on personal exposure to heat stress? What is the impact of the intervention on health outcomes, including heart rate, and heart rate variability, and sleep quality?
Participants will have cooling infrastructure and/or equipment installed in their home; have heat stress sensors installed inside and outside their home and wear personal heat stress monitors; allow some biological functions such as heat rate, heat rate variability, and sleep quality.
Detailed description
During the last two decades, nearly half a million people died each year from heat-related causes; climate change is expected to exacerbate the burden of adverse health outcomes. Heat stress has been associated with an increase in all-cause mortality, cardiovascular disease and mortality, chronic respiratory disease, lower respiratory infection, chronic kidney disease, diabetes, adverse pregnancy outcomes, and poor mental health. The investigators will to determine personal heat stress of low-income individuals who do not have access to air conditioning, evaluate the effectiveness, acceptability, feasibility, and scalability of building-level cooling strategies to reduce indoor heat stress among vulnerable individuals, and evaluate the impact of these interventions on heart rate. A disproportionate burden of heat-related death and disease is borne by low-income communities because they do not have access to cooling and suffer from comorbidities that exacerbate the adverse impacts of heat stress. South Asia faces the greatest current and predicted loss in disability-adjusted life years due to heat stress, and heat stress is particularly strong in informal settlements. As such, the investigators plan to conduct this study in informal settlements in Dhaka, Bangladesh. The overall hypothesis is that individuals who live in homes with corrugated iron roofs and walls are at elevated risk of heat stress and that it is possible to modify homes to prevent increases in heart rate associated with heat stress, ultimately reducing cardiovascular morbidity and mortality. The investigators will evaluate the impact of cooling infrastructure and/or equipment interventions on residents' heart rate (primary outcome), heart rate variability, sleep quality, self-reported thermal comfort, mental health, wellness, fatigue, and indoor thermal conditions (secondary outcomes).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-wedge randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Indoor cooling intervention | Experimental | Other: Cooling interventionHouseholds in this arm will receive infrastructure and/or equipment intended to cool the house in the hot season. |
| Control | No intervention | –Households in this arm will not receive any intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- House is located in an informal settlement in an urban area in Bangladesh
- The house has a corrugated iron roof and corrugated iron walls
- The household plans to remain in the house from Feb-Nov
- Lives in an eligible household
Key exclusion criteria (8 listed)
- There is an inhabited structure about the house
- The landlord does not allow the proposed intervention
- Has access to air conditioning in their home or place of work
- Reports they are pregnant
- Has hypertension, as measured by study staff
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 |
|---|---|---|
| Cooling interventionInfrastructure and/or equipment that cools the house in the hot season | Other | Indoor cooling intervention |
Primary outcome
Heart rate
Time frame: 0, 2, and 4 weeks
resting heart rate (beats per minute, bpm), where lower heart rate is better
6 secondary outcomes
Heart rate variability
Time frame: 0, 2, and 4 weeks
Sleep quality
Time frame: 0, 2, and 4 weeks
Irritability
Time frame: 0, 2, and 4 weeks
Environmental Symptoms
Time frame: 0, 2, and 4 weeks
Depression
Time frame: 0, 2, and 4 weeks
Anxiety
Time frame: 0, 2, and 4 weeks
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 20 Feb 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be stored in icddrb's data repository
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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.
Laura H Kwong, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling intervention in people with Heat Stress, run by University of California, Berkeley at 1 site in Bangladesh.
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 4 inclusion and 8 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 20 Feb 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 Bangladesh. 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 Laura H Kwong, PhD (+1-650-332-4667, lakwong@berkeley.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 0, 2, and 4 weeks). 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 20 Feb 2026.