跳至主要内容
临床试验/NCT07196436
NCT07196436招募中不适用

Energy Recovery Ventilation and Air Cleaner Interventions to Improve Indoor Air Quality, Mold Control, and Asthma-Related Health Outcomes Among Inner-City Children and Adults in Low-Income Households

The University of Texas at Arlington4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月10日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
4
主要终点
Pulmonary Function (Spirometry)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with physician-diagnosed asthma, including both adults and children aged 5-17
  • Homeowners living in the DFW metropolitan area, TX

排除标准

  • Participants living in homes with any smokers

结局指标

主要结局

Pulmonary Function (Spirometry)

时间窗: Baseline; 6 months; 18 months; 24 months

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.

Asthma Control Test Score

时间窗: From enrollment to the end of intervention at 1 month (24 months in total)

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.

次要结局

  • Asthma-Related Quality Of Life (Adults)(Baseline; 6 months; 18 months; 24 months)
  • Asthma-Related Quality Of Life (Children)(Baseline; 6 months; 18 months; 24 months)
  • Stress Levels(Baseline; 6 months; 18 months; 24 months)
  • Sleep Quality(Baseline; 6 months; 18 months; 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Insung Kang, PhD

Assistant Professor

The University of Texas at Arlington

研究点 (4)

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