Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days
研究概览
简要总结
Fine particulate matter <2.5 µm (PM2.5) air pollution is the fifth leading risk factor for global mortality, with the largest portion of deaths due to cardiovascular disease (CVD). While several mechanisms are responsible, PM2.5-induced elevations in blood pressure (BP) may be relevant. Indoor portable air cleaners (PACs) are a novel approach to reduce exposure to PM2.5 and potentially lower blood pressure. The current study is being conducted to provide evidence that PACs reduce PM2.5 exposure and lower systolic blood pressure (SBP) in key patient populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •self-reported nonsmokers living in a nonsmoking household.
- •adults living with hypertension (HTN) from NYC public housing.
排除标准
- •History of major known arrhythmias (e.g. atrial flutter or fibrillation, ventricular tachycardia).
- •Screening systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg (i.e. severe hypertension by the 2017 ACC/AHA BP guideline).
- •A change in drug regimen in the prior 2 weeks or a planned change in drug regimen during the first 30 days for those taking antihypertensive medication.
- •Current smoking or living with an active smoker who smokes indoors
- •Planned travel out of NYC for ≥2 weeks in next 6 months
- •Incarcerated
- •Unable/unwilling to consent
- •Established cardiovascular disease
- •End-stage renal disease (chronic kidney disease stage IV or on dialysis)
- •Barrier to technology use (e.g., visual or hearing impairment)
- •Lung disease requiring oxygen
- •Cancer receiving treatment
研究组 & 干预措施
Active Portable Air Cleaner (PAC)
Using a double-blind randomized process, active PACs (with HEPA filters inside) will be assembled and placed in the bedroom of study participants. Initiation of the PAC devices will occur at baseline on Day 0. After completion of enrollment, consent and the placement of PACs, electricity monitors, and PurpleAir monitoring, the PAC will be turned on. Participants will be instructed to keep the PACs on in bedrooms during the study duration, closing bedroom doors at night and during the day, when possible. The PAC will run for 24 hours on Day 0 of the study protocol before the 30-day treatment period begins. A kilowatt meter will be installed with the PAC to monitor electricity usage as a measure of adherence.
干预措施: Active PAC (Device)
Sham PAC
Using a double-blind randomized process, sham PACs (with no filters inside) will be assembled and placed in the bedroom of study participants. Initiation of the PAC devices will occur at baseline on Day 0. After completion of enrollment, consent and the placement of PACs, electricity monitors, and PurpleAir monitoring, the PAC will be turned on. Participants will be instructed to keep PACs on in bedrooms during the study duration, closing bedroom doors at night and during the day, when possible. The PAC will run for 24 hours on Day 0 of the study protocol before the 30-day treatment period begins. A kilowatt meter will be installed with the PAC to monitor electricity usage as a measure of adherence.
干预措施: Sham PAC (Device)
结局指标
主要结局
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days
时间窗: Up to Day 30
Participants measure HBP every day between 6-9 am.
次要结局
- Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days(Up to Day 90)
- Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days(Up to Day 180)