NCT06979258

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,539

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started May 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
May 2025Mar 2029

First Submitted

Initial submission to the registry

April 25, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

February 20, 2026

Status Verified

May 1, 2025

Enrollment Period

3.9 years

First QC Date

April 25, 2025

Last Update Submit

February 17, 2026

Conditions

Heat Stress

Keywords

heat stresscoolingheart rateheart rate variabilitysleep qualityBangladesh

Outcome Measures

Primary Outcomes (1)

  • Heart rate

    resting heart rate (beats per minute, bpm), where lower heart rate is better

    0, 2, and 4 weeks

Secondary Outcomes (6)

  • Heart rate variability

    0, 2, and 4 weeks

  • Sleep quality

    0, 2, and 4 weeks

  • Irritability

    0, 2, and 4 weeks

  • Environmental Symptoms

    0, 2, and 4 weeks

  • Depression

    0, 2, and 4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Indoor cooling intervention

EXPERIMENTAL

Households in this arm will receive infrastructure and/or equipment intended to cool the house in the hot season.

Other: Cooling intervention

Control

NO INTERVENTION

Households in this arm will not receive any intervention

Interventions

Cooling interventionOTHER

Infrastructure and/or equipment that cools the house in the hot season

Indoor cooling intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • There is an inhabited structure about the house
  • The landlord does not allow the proposed intervention
  • Lives in an eligible household
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Dhaka Division, 1212, Bangladesh

RECRUITING

MeSH Terms

Conditions

Heat Stress DisordersSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Wounds and InjuriesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Laura H Kwong, PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura H Kwong, PhD

CONTACT

+1-650-332-4667lakwong@berkeley.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Stepped-wedge randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2025

First Posted

May 18, 2025

Study Start

May 12, 2025

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Last Updated

February 20, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Deidentified individual participant data will be stored in icddrb's data repository

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
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.
Access Criteria
Reasonable request

Locations

BA(1)