Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT06979258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heat Stress Exposure Among Low-Income Residents in Bangladesh and Evaluation of Indoor Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Stepped-wedge randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1539}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '0, 2, and 4 weeks', 'description': 'resting heart rate (beats per minute, bpm), where lower heart rate is better'}], 'secondaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': '0, 2, and 4 weeks', 'description': 'resting heart rate (beats per minute, bpm) variability, where higher variability is better'}, {'measure': 'Sleep quality', 'timeFrame': '0, 2, and 4 weeks', 'description': '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'}, {'measure': 'Irritability', 'timeFrame': '0, 2, and 4 weeks', 'description': 'Self-reported irritability, as measured by the Brief Irritability Test (BITe), where a lower score is better'}, {'measure': 'Environmental Symptoms', 'timeFrame': '0, 2, and 4 weeks', 'description': 'Environmental symptoms, as measured by the abbreviated environmental symptoms questionnaire, where a lower score is better'}, {'measure': 'Depression', 'timeFrame': '0, 2, and 4 weeks', 'description': '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.'}, {'measure': 'Anxiety', 'timeFrame': '0, 2, and 4 weeks', 'description': 'Anxiety, as measured by the Generalised Anxiety Disorder with 7 questions (GAD-7). A total GAD-7 score of \\>= 8 indicates anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heat stress', 'cooling', 'heart rate', 'heart rate variability', 'sleep quality', 'Bangladesh'], 'conditions': ['Heat Stress']}, 'descriptionModule': {'briefSummary': '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:\n\nWhat 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?\n\nParticipants 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.', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for the house:\n\n* House is located in an informal settlement in an urban area in Bangladesh\n* The house has a corrugated iron roof and corrugated iron walls\n* The household plans to remain in the house from Feb-Nov\n\nExclusion Criteria for the house\n\n* There is an inhabited structure about the house\n* The landlord does not allow the proposed intervention\n\nInclusion Criteria for the participant:\n\n* Lives in an eligible household\n\nExclusion Criteria for the participant\n\n* Has access to air conditioning in their home or place of work\n* Reports they are pregnant\n* Has hypertension, as measured by study staff\n* Has diabetes, as measured by study staff\n* Self-reports cardiovascular disease / chronic cardiac condition\n* Self-reports respiratory disease / chronic respiratory condition'}, 'identificationModule': {'nctId': 'NCT06979258', 'briefTitle': 'Heat Stress Exposure Among Low-Income Residents in Bangladesh and Evaluation of Indoor Interventions', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'Heat Stress: Exposure Among Low-Income Residents in Bangladesh and Evaluation of Indoor Interventions', 'orgStudyIdInfo': {'id': '2024-08-17719'}, 'secondaryIdInfos': [{'id': '1R01ES035910', 'link': 'https://reporter.nih.gov/quickSearch/1R01ES035910', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indoor cooling intervention', 'description': 'Households in this arm will receive infrastructure and/or equipment intended to cool the house in the hot season.', 'interventionNames': ['Other: Cooling intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Households in this arm will not receive any intervention'}], 'interventions': [{'name': 'Cooling intervention', 'type': 'OTHER', 'description': 'Infrastructure and/or equipment that cools the house in the hot season', 'armGroupLabels': ['Indoor cooling intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1212', 'city': 'Dhaka', 'country': 'Bangladesh', 'contacts': [{'name': 'Nuhu Amin, BDS', 'role': 'CONTACT', 'email': 'nuhu.amin@icddrb.org', 'phone': '+8802222277001', 'phoneExt': '4023'}, {'name': 'Nuhu Amin, BDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Laura H Kwong, PhD', 'role': 'CONTACT', 'email': 'lakwong@berkeley.edu', 'phone': '+1-650-332-4667'}], 'overallOfficials': [{'name': 'Laura H Kwong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Berkeley'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The investigators expect the data to become available at least by 1 Jan 2030. The investigators have no plan for when the data will become unavailable.', 'ipdSharing': 'YES', 'description': "Deidentified individual participant data will be stored in icddrb's data repository", 'accessCriteria': 'Reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}