Resting Heart RateREFLECTNCT06570993
Assessing the Effects of Cool Roofs on Indoor Environments and Health in Niue
A study testing Cool roof in people with Resting Heart Rate and Blood Glucose Control, run by Aditi Bunker at 1 site in Niue.
Trial summary
Ambient air temperatures in the Pacific have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resting Heart Rate, Blood Glucose Control, Depression
- What is being tested?
- Cool roof
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteNiue
- Study dates
- 4 Sep 2024to 31 Jan 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant criteria:
- Consenting adults aged 18 years and over.
- Expected to be available to participate in the study for at least nine months in the next 12 months.
- Household criteria:
- House has a metal roof.
- House is single-story.
Who cannot join
- Household criteria:
- Unstable house structure that does not permit the application of cool roof materials.
- Inaccessible by the research team.
- Significant roof damage defined as any penetrative roof defect that results in a hole in the roof OR over 25% of the roof rusted.
Trial locations and contacts
1 site in 1 country.
Niue1 site
University of Auckland
Auckland
About this study
Official title: A Cluster Randomised Controlled Trial (cRCT) Evaluating the Effects of Cool Roofs on Health, Environmental and Economic Outcomes in Niue
Ambient air temperatures in the Pacific have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions in the Pacific are susceptible to increased heat exposure.
Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in household occupants.
The long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in Niue. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in Niue.
Read the detailed description
Increasing heat exposure from climate change is causing and exacerbating heat-related illnesses in millions worldwide - particularly in low resource settings. June 2024 was the 13th consecutive hottest month on record globally - shattering previous records. Heat exposure can instigate and worsen health conditions including cardiovascular, metabolic, endocrine and respiratory disease, heat-related illnesses, pregnancy complications, and mental health conditions. Adaptation is essential for protecting people from increasing heat exposure. The built environment, especially homes, are ideal for deploying interventions to reduce heat exposure and accelerate adaptation efforts. However, there currently is a lack of evidence on a global scale - generated through empirical studies - guiding the uptake of interventions to reduce heat stress in low resource settings.
Pacific Islands and other small island developing states are among the most vulnerable to the adverse impacts of climate change and are likely to experience increases in ambient air temperature over the coming decades. People in Niue are exposed to heat and humidity year-round. The Pacific Islands have a large burden of non-communicable diseases (NCDs), with nearly three-quarters of deaths due to NCDs. The combined burden of heat and NCDs places Pacific Island populations at greater risk of adverse health effects from heat extremes.
Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and lower energy use, offering protection to home occupants from extreme heat. The investigators therefore aim to conduct a cluster-randomized controlled trial investigating the effects of cool-roof use on health, environmental and economic outcomes in Niue.
The trial will quantify whether cool roofs are an effective passive home cooling intervention with beneficial health effects for vulnerable populations in Niue. Findings will inform regional policy responses on scaling cool roof implementation to protect people from increasing heat exposure driven by climate change.
- Conditions
- Resting Heart Rate, Blood Glucose Control, Depression, Heat-related Symptoms, Physician Diagnosed Heat-related Illnesses, Food Insecurity
- Being tested
- Cool roof
- Keywords
- Hot Temperature, Humidity, Housing, Heart rate, Cardiovascular, Depression, Mental health, Blood glucose, Diabetes, Cool roof, Heat Stress
- Medical subject headings
- Depression, Personal Satisfaction, Dehydration, Sleep Initiation and Maintenance Disorders, Aggression, Psychological Well-Being, Diabetes Mellitus, Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cool roofOther
Cool roofs are a heat-reflecting material that can be applied to existing household roofing in the form of a liquid-applied membrane. Cool roofs work by increasing solar reflectance (the ability to reflect the visible wavelengths of sunlight, reducing heat transfer to the surface) and thermal emittance (the ability to radiate absorbed solar energy) thereby reducing the amount of heat transferred into the home.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Households will receive sunlight reflecting 'cool roof' coating on their roofs. Receives: Other: Cool roof |
| Control | No intervention | No cool roof application. Households will keep their original roofing for the duration of the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting heart rate
Resting heart rate in beats per minute measured as the average of three readings in the left arm over one hour using Blip portable automated sphygmomanometers.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Blood glucose control
Three month average of blood glucose in mmol/mol measured as glycosylated hemoglobin (HbA1c) using capillary blood and the HemoCue® HbA1c 501 System.
Measured: Two measurements will be taken: one at baseline and one in the last month of three consecutive hottest months.
Depression
Self-reported presence and frequency of symptoms of depression assessed using aggregate score of the Patient Health Questionnaire 9 (PHQ-9).
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Secondary outcomes (22)
Heat-related symptoms
Self-reported heat-related symptoms in the past month, assessed using a recall questionnaire.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Physician diagnosed heat-related illnesses
Self-reported new diagnosis from a medical practitioner of a heat-related illness in the last month assessed using a recall questionnaire.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Food insecurity
Self-reported experience based measure of individual food security assessed using the Food Insecurity Experience Scale (FIES).
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Diet quality
Self-reported individual food group consumption in the previous 24 hours assessed using the Diet Quality Questionnaire (DQQ).
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Health-related quality of life
Current self-reported health-related quality of life assessed using the EuroQol EQ-5D-5L quality assessment tool.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Indoor thermal comfort
Self-reported household heat, humidity and comfort experience over the last four weeks assessed using a recall questionnaire.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Coping ability
Self-reported coping strategies for high indoor temperatures assessed using a recall questionnaire.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Life satisfaction
Current self-reported life satisfaction assessed using the World Values Survey.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Healthcare provider utilization
Self-reported healthcare provider utilization in the past four weeks assessed using a recall questionnaire.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Hospitalization
Self-reported overnight hospital stay in the past four weeks assessed using a recall questionnaire.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Systolic Blood Pressure
Maximum blood pressure (mmHg) during systole measured as the average of three readings in the left arm over one hour using Blip portable automated sphygmomanometers.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Diastolic Blood Pressure
Minimum blood pressure (mmHg) during diastole measured as the average of three readings in the left arm over one hour using Blip portable automated sphygmomanometers.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Cognition
Accuracy and response time to the four-choice Deary-Liewald Test measured using the CogniFit app-based assessment tool.
Measured: Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Inner Ear Canal Temperature
Internal body temperature (℃) measured once using Braun digital ear thermometer.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Dehydration
Dehydration as indicated by urine specific gravity ≥1.020 measured as urine specific gravity using Siemens Multistix SG dipstick.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Sleep quality
Self-reported sleep distrubance assessed using the Athens Insomnia Scale (AIS).
Measured: Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Aggression
Self-reported personal aggresion assessed using the Buss-Perry Aggression Questionnaire-Ultra Short Form (BPAQ-ML).
Measured: Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Productivity
Self-reported job absenteeism and presenteeism assessed using the Health and Work Performance Questionnaire Short Form (HPQ-SF).
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Indoor air temperature
Indoor air temperature (℃) measured using Hobo MX1101 heat and humidity measurement device.
Measured: Measurements at 15 minute intervals for 12 months.
Indoor relative humidity
Ratio of the amount of water vapor present in the air to the greatest amount possible at the same temperature (%) measured using Hobo MX1101 heat and humidity measurement device.
Measured: Measurements at 15 minute intervals for 12 months.
Indoor heat index
Index that combines air temperature and relative humidity (℃) based on temperature and humidity measurements from the Hobo MX1101 heat and humidity measurement device calculated using the formulae endorsed by the US National Oceanic and Atmospheric Administration.
Measured: Measurements at 15 minute intervals for 12 months.
Household energy expenditure
Self-reported household energy expenditure assessed using a recall questionnaire from the head of the household.
Measured: Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start4 Sep 2024
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resting Heart RateStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aditi Bunker
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, London School of Hygiene and Tropical Medicine, Rutgers University, Boston University, Secretaría de Educación Pública, México, University of Ouagadougou, Burkina Faso, Indian Institute of Public Health, India, Labfront, Cognifit, Resene, Pacific Community, Habitat for Humanity, The Tindall Foundation
- Responsible party
- Sponsor-investigator, Aditi Bunker, University of Auckland, New Zealand
- Investigators
- Collin Tukuitonga, Sir. Dr., Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570993
- Sponsor's protocol ID
- 3728160
- Other IDs
- 226745/Z/22/Z
- Acronym
- REFLECT
- Status last verified
- Feb 2026
- First submitted
- 22 Aug 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that can be shared unconditionally underpinning the published research articles will be made available to other researchers at the time of publication, and data will be linked via the article DOI. Data that cannot be unconditionally shared upon publication owing to confidentiality or data protection requirements will be identified as such and a contact email will be provided in relevant publications for data access enquiries by other researchers. It is expected that demographic data of people at the study sites (family size and composition, basic socioeconomic indicators) may contain personally identifiable information and location data. All such data will be removed prior to storage on online data repositories and therefore will be available to be publicly shared at the time of publication of manuscripts.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Controlled Trial (cRCT) Evaluating the Effects of Cool Roofs on Health, Environmental and Economic Outcomes in Niue
- ClinicalTrials.gov ID
- NCT06570993
- Acronym / sponsor ID
- REFLECT / 3728160
- Conditions
- Resting Heart Rate, Blood Glucose Control, Depression, Heat-related Symptoms, Physician Diagnosed Heat-related Illnesses, Food Insecurity
- Keywords
- Hot Temperature, Humidity, Housing, Heart rate, Cardiovascular, Depression, Mental health, Blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Aditi BunkerUniversity, hospital or other
- Collaborators
- Heidelberg University, London School of Hygiene and Tropical Medicine, Rutgers University, Boston University, Secretaría de Educación Pública, México, University of Ouagadougou, Burkina Faso, Indian Institute of Public Health, India, Labfront, Cognifit, Resene, Pacific Community, Habitat for Humanity, The Tindall Foundation
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 26 Aug 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.
Ambient air temperatures in the Pacific have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions in the Pacific are susceptible to increased heat exposure.
Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in household occupants.
The long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in Niue. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in Niue.
Detailed description
Increasing heat exposure from climate change is causing and exacerbating heat-related illnesses in millions worldwide - particularly in low resource settings. June 2024 was the 13th consecutive hottest month on record globally - shattering previous records. Heat exposure can instigate and worsen health conditions including cardiovascular, metabolic, endocrine and respiratory disease, heat-related illnesses, pregnancy complications, and mental health conditions. Adaptation is essential for protecting people from increasing heat exposure. The built environment, especially homes, are ideal for deploying interventions to reduce heat exposure and accelerate adaptation efforts. However, there currently is a lack of evidence on a global scale - generated through empirical studies - guiding the uptake of interventions to reduce heat stress in low resource settings.
Pacific Islands and other small island developing states are among the most vulnerable to the adverse impacts of climate change and are likely to experience increases in ambient air temperature over the coming decades. People in Niue are exposed to heat and humidity year-round. The Pacific Islands have a large burden of non-communicable diseases (NCDs), with nearly three-quarters of deaths due to NCDs. The combined burden of heat and NCDs places Pacific Island populations at greater risk of adverse health effects from heat extremes.
Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and lower energy use, offering protection to home occupants from extreme heat. The investigators therefore aim to conduct a cluster-randomized controlled trial investigating the effects of cool-roof use on health, environmental and economic outcomes in Niue.
The trial will quantify whether cool roofs are an effective passive home cooling intervention with beneficial health effects for vulnerable populations in Niue. Findings will inform regional policy responses on scaling cool roof implementation to protect people from increasing heat exposure driven by climate change.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Cool roofHouseholds will receive sunlight reflecting 'cool roof' coating on their roofs. |
| Control | No intervention | –No cool roof application. Households will keep their original roofing for the duration of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consenting adults aged 18 years and over.
- Expected to be available to participate in the study for at least nine months in the next 12 months.
- House has a metal roof.
- House is single-story.
Key exclusion criteria (4 listed)
- Unstable house structure that does not permit the application of cool roof materials.
- Inaccessible by the research team.
- Significant roof damage defined as any penetrative roof defect that results in a hole in the roof OR over 25% of the roof rusted.
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 |
|---|---|---|
| Cool roofCool roofs are a heat-reflecting material that can be applied to existing household roofing in the form of a liquid-applied membrane. Cool roofs work by increasing solar reflectance (the ability to reflect the visible wavelengths of sunlight, reducing heat transfer to the surface) and thermal emittance (the ability to radiate absorbed solar energy) thereby reducing the amount of heat transferred into the home. | Other | Intervention |
Primary outcome
Resting heart rate
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Resting heart rate in beats per minute measured as the average of three readings in the left arm over one hour using Blip portable automated sphygmomanometers.
Blood glucose control
Time frame: Two measurements will be taken: one at baseline and one in the last month of three consecutive hottest months.
Three month average of blood glucose in mmol/mol measured as glycosylated hemoglobin (HbA1c) using capillary blood and the HemoCue® HbA1c 501 System.
Depression
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Self-reported presence and frequency of symptoms of depression assessed using aggregate score of the Patient Health Questionnaire 9 (PHQ-9).
22 secondary outcomes
Heat-related symptoms
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Physician diagnosed heat-related illnesses
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Food insecurity
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Diet quality
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Health-related quality of life
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Indoor thermal comfort
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Coping ability
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Life satisfaction
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Healthcare provider utilization
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Hospitalization
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Systolic Blood Pressure
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Diastolic Blood Pressure
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Cognition
Time frame: Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Inner Ear Canal Temperature
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Dehydration
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Sleep quality
Time frame: Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Aggression
Time frame: Eight measurements: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Productivity
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Indoor air temperature
Time frame: Measurements at 15 minute intervals for 12 months.
Indoor relative humidity
Time frame: Measurements at 15 minute intervals for 12 months.
Indoor heat index
Time frame: Measurements at 15 minute intervals for 12 months.
Household energy expenditure
Time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering the three consecutive hottest months and four alternate months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data that can be shared unconditionally underpinning the published research articles will be made available to other researchers at the time of publication, and data will be linked via the article DOI. Data that cannot be unconditionally shared upon publication owing to confidentiality or data protection requirements will be identified as such and a contact email will be provided in relevant publications for data access enquiries by other researchers. It is expected that demographic data of people at the study sites (family size and composition, basic socioeconomic indicators) may contain personally identifiable information and location data. All such data will be removed prior to storage on online data repositories and therefore will be available to be publicly shared at the time of publication of manuscripts.
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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.
Collin Tukuitonga, Sir. Dr. principal investigator
University of Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cool roof in people with Resting Heart Rate and Blood Glucose Control, run by Aditi Bunker at 1 site in Niue.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 27 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 Niue. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resting heart rate (time frame: Eight measurements will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.). The study lists 3 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 27 Feb 2026.