Asthma Intervention With Residential Ventilation and Air Cleaner (AIRVAC) Study
Part of paid clinical trials in Arlington, Texas.
- Sponsor
- The University of Texas at Arlington
- Study ID
- NCT07196436
- Status
- Recruiting
Conditions
- Asthma Control
- Pulmonary Function
- Quality of Life
- Sleep Quality
- Stress
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Energy Recovery Ventilator — DEVICEA mechanical ventilation system that exchanges stale indoor air with fresh outdoor air while transferring heat and moisture between the incoming and outgoing air streams
- Portable Air Cleaner — DEVICEA standalone home device that filters indoor air to remove particulate matter, allergens, and other pollutants
- Energy Recovery Ventilator (Sham) — DEVICEA home-installed ERV unit that operates in recirculation mode only, providing no fresh air exchange or heat/moisture transfer, serving as a placebo for study purposes.
- Portable Air Cleaner (Sham) — DEVICEA portable air cleaner that appears to operate like an active unit but does not contain a HEPA filter and does not clean the air, serving as a placebo for study purposes
Study Details
The primary goal of this study is to investigate the comparative long-term (i.e., 1-year) effectiveness of energy recovery ventilators (ERVs) and portable air cleaners (PACs) in reducing indoor air pollutants and mold levels and improving asthma-related health outcomes in inner-city children and adults with asthma in low-income households in the Dallas-Fort Worth (DFW) metropolitan area, TX. Secondary goals include: (1) examining associations among asthma outcomes, exposure to indoor air pollutants and mold, and housing-related factors, (2) conducting a cost-benefit analysis of ERV and PAC interventions for improving IAQ, mold control, and health outcomes, and (3) evaluating the utility of cost-effective methods and protocols for measuring IAQ and mold for indoor air pollution epidemiology studies and for providing practical information to patients and their physicians. Using a double-blind, placebo-controlled randomized controlled trial, 80 households will be assigned to receive active or placebo versions of ERVs or PACs. Environmental exposures and housing conditions will be monitored alongside comprehensive health assessments, including lung function tests and validated surveys on asthma control, quality of life, stress, and sleep quality.
Key Dates
- Start date
- Oct 10, 2025
- Status verified
- Oct 2025
- Primary completion
- Jan 31, 2028
- Completion
- Feb 28, 2028
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Active ERVA group that will receive an active energy recovery ventilator for 1 year
- Sham Comparator: Sham ERVA group that will receive a sham energy recovery ventilator (recirculation mode only) for 1 year
- Active Comparator: Active PACA group that will receive an active portable air cleaner for 1 year
- Sham Comparator: Sham PACA group that will receive a sham portable air cleaner (HEPA filter removed) for 1 year
Primary Outcome Measure
Pulmonary Function (Spirometry) [ Time Frame: Baseline; 6 months; 18 months; 24 months ]
Central Contacts
- Insung Kang, Ph.D.817-272-2167
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas at Arlington | Arlington | Texas | 76010 | June Young Park, Ph.D. (SUB_INVESTIGATOR) Yike Shen, Ph.D. (SUB_INVESTIGATOR) |
| Rebuilding Together North Texas | Plano | Texas | 75025 |
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