Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 440
- Locations
- 1
- Primary Endpoint
- Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •self-reported nonsmokers living in a nonsmoking household.
- •adults living with hypertension (HTN) from NYC public housing.
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Sham PAC (Device)
Outcomes
Primary Outcomes
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days
Time Frame: Up to Day 30
Participants measure HBP every day between 6-9 am.
Secondary Outcomes
- 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)