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NCT05874479 | Recruiting | Blood Pressure

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

NYU Langone Health

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.

Condition or disease

Blood Pressure

Intervention/treatment

Active PAC

Sham PAC

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 440 participants
Masking : Double
Primary Purpose : Prevention
Official Title : Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents
Actual Study Start Date : December 20, 2023
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : March 2028
Arm Intervention/treatment

Experimental: 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.

Device: Active PAC

Sham Comparator: 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.

Device: Sham PAC
Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents

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

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Locations

Recruiting

United States, New York

NYU Langone Health

New York, New York, United States, 10016