Health TrialsbyHealthPanel

Asthma Intervention With Residential Ventilation and Air Cleaner (AIRVAC) Study

ConditionsAsthma ControlPulmonary FunctionQuality of LifeStressSleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorThe University of Texas at Arlington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with physician-diagnosed asthma, including both adults and children aged 5-17

Homeowners living in the DFW metropolitan area, TX

Disqualifiers

Participants living in homes with any smokers

Trial design

Design model

Parallel

Treatments tested in this trial

  • Energy Recovery Ventilator

    Device

    A 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

    Device

    A standalone home device that filters indoor air to remove particulate matter, allergens, and other pollutants

  • Energy Recovery Ventilator (Sham)

    Device

    A 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)

    Device

    A 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

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Active ERVActive comparator 1 intervention
Group B: Sham ERVSham comparator 1 intervention
Group C: Active PACActive comparator 1 intervention
Group D: Sham PACSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pulmonary Function (Spirometry)

Pulmonary function will be assessed using an EasyOne Air spirometer. The primary parameters measured include Forced Expiratory Volume in 1 second (FEV₁), Forced Vital Capacity (FVC), and the FEV₁/FVC ratio.

Time frame
Baseline; 6 months; 18 months; 24 months
2

Asthma Control Test Score

Asthma Control Test (ACT) for adults and Childhood Asthma Control Test (C-ACT) for children every month throughout the 2-year study. ACT score range: 5-25; higher scores indicate better asthma control. C-ACT score range: 0-27; higher scores indicate better asthma control.

Time frame
From enrollment to the end of intervention at 1 month (24 months in total)

Secondary outcomes

1

Asthma-Related Quality Of Life (Adults)

36-Item Short Form Health Survey (SF-36) for adult participants. SF-36 score range: 0-100; higher scores indicate better health status.

Time frame
Baseline; 6 months; 18 months; 24 months
2

Asthma-Related Quality Of Life (Children)

Pediatric Quality of Life Inventory (PedsQL) for child participants. PedsQL score range: 0-100; higher scores indicate better quality of life.

Time frame
Baseline; 6 months; 18 months; 24 months
3

Stress Levels

Perceived Stress Scale (PSS) for adults and Perceived Stress Scale for Children (PSS-C) for children. PSS score range: 0-40; higher scores indicate worse perceived stress. PSS-C score range: 0-39; higher scores indicate worse perceived stress.

Time frame
Baseline; 6 months; 18 months; 24 months
4

Sleep Quality

PROMIS Sleep Disturbance Survey for both adult and child participants. PROMIS Sleep Disturbance score range: 20-80 (mean = 50, SD = 10); higher scores indicate worse sleep disturbance.

Time frame
Baseline; 6 months; 18 months; 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas at Arlington

Lead sponsor

Rebuilding Together North Texas

Collaborator

Source ClinicalTrials.gov
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