An interventional study of Energy Recovery Ventilator and Portable Air Cleaner in Asthma Control, Pulmonary Function and Quality of Life, sponsored by The University of Texas at Arlington. Recruiting at 2 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2025-10-29.
Sponsored by The University of Texas at Arlington · Not applicable, Interventional, and Treatment
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.
This study will evaluate the long-term effectiveness of energy recovery ventilators (ERVs) and portable air cleaners (PACs) in reducing indoor concentrations of air pollutants and mold, and improving health outcomes among children and adults with asthma. The study design will utilize a double-blind, placebo-controlled, 4-arm, parallel-group, randomized controlled trial with 1-year observation and 1-year intervention periods. Eligible children (n ≥ 40) and adults (n ≥ 40) with asthma from 80 households will be recruited from an applicant pool for RTNTX home retrofit programs. Participants will be randomized to receive one of four different interventions midway through the study: (1) ERV, (2) sham/placebo ERV, (3) PAC, or (4) sham/placebo PAC. All participants and field research team will be blinded to whether participants receive the active or sham/placebo intervention. ERVs will be equipped with minimum efficiency reporting value (MERV) 13 filters to capture particulate matter from incoming outdoor air, while sham/placebo ERVs will be modified to operate only in recirculation mode (no outdoor air ventilation). PACs will have high efficiency particulate air (HEPA) and carbon filters, whereas sham/placebo PACs will have the HEPA and carbon filters removed, leaving only the pre-filters. These objectives will be achieved through a combination of (i) baseline housing condition assessments for characterizing housing-related factors such as housing conditions, health and safety issues, and basic building performance, that may contribute to asthma exacerbations and affect the installation of ERVs, (ii) field measurements of indoor air pollutants (i.e., PM, VOCs, NO2, CO, and CO2) and mold levels (both air and surface samples), and (iii) comprehensive asthma outcome assessments via participant-reported health surveys for asthma control, asthma-related quality of life, stress, and sleep quality. Asthma control will be tracked monthly using the Asthma Control Test (ACT) for adults and the Childhood Asthma Control Test (C-ACT) for children. Quality of life, stress, and sleep will be assessed during home visits using validated instruments, including the 36-Item Short Form Health Survey (SF-36) and the Pediatric Quality of Life Inventory (PedsQL) for quality of life; the Perceived Stress Scale (PSS) and the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Stress measure for stress; and PROMIS Adult and Pediatric Sleep measures for sleep quality.
Results from the research are expected to identify practical and effective commercially available systems that can (1) investigate the long-term effects of different mechanisms between ERVs and PACs on IAQ, mold, and health outcomes in asthmatic children and adults; (2) provide novel data on associations among asthma outcomes, indoor air pollution and mold exposure, and housing-related factors; (3) evaluate the long-term health benefits, including reduced direct costs for asthma and estimated mortality attributable to improved IAQ and mold, versus the total costs of interventions; and (4) investigate the utility of low-cost sensors for assessing housing-related hazards and epidemiology studies, and for providing actionable information on IAQ and mold levels to patients and their physicians.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 80 is close to the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →The University of Texas at Arlington is the lead sponsor of 37 studies on the registry; 11 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
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Exclusion Criteria:
A group that will receive an active energy recovery ventilator for 1 year
Device: Energy Recovery Ventilator
A group that will receive a sham energy recovery ventilator (recirculation mode only) for 1 year
Device: Energy Recovery Ventilator (Sham)
A group that will receive an active portable air cleaner for 1 year
Device: Portable Air Cleaner
A group that will receive a sham portable air cleaner (HEPA filter removed) for 1 year
Device: Portable Air Cleaner (Sham)
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
Also known as: ERV
A standalone home device that filters indoor air to remove particulate matter, allergens, and other pollutants
Also known as: PAC, HEPA Air Cleaner, Residential Air Cleaner, Room Air Cleaner, Air Purifier
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.
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
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
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)
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
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
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
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
Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality concerns for participants and because the consent forms do not include provisions for public data sharing
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