Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents

Study Overview
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Brief Summary
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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.

Official Title
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Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: Active PAC
* Device: Sham PAC


Participation Criteria
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Eligibility Criteria
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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 Pregnant 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Portable Air Cleaner (PAC)<br>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. | Device: Active PAC<br>* The active PAC will contain HEPA filters inside the device.<br>|
| Sham Comparator: Sham PAC<br>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. | Device: Sham PAC<br>* The sham PAC will contain no HEPA filters inside the device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days | Participants measure HBP every day between 6-9 am. | Up to Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days | Participants measure HBP every day between 6-9 am. | Up to Day 90 | 
| Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days | Participants measure HBP every day between 6-9 am. | Up to Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-measured morning home systolic blood pressure (AM H-SBP)