Recruiting

AIR Pollution

Sponsor:

NYU Langone Health

Code:

NCT05874479

Conditions

Blood Pressure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active PAC

Sham PAC

Study Details

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.

Conditions

Blood Pressure

Study ID

NCT05874479

Start date

Dec 20, 2023

Status verified date

Jul, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Active PAC

The active PAC will contain HEPA filters inside the device.

Sham PAC

The sham PAC will contain no HEPA filters inside the device.

Primary outcome measure

  • Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days [ Time Frame: Up to Day 30 ]

Central Contacts and Locations

Central contacts

Jonathan Newman

(212) 263-9393AirPressureNYC@nyulangone.org

Elle Anastasiou Pesante

(646) 501-3613elle.anastasiou@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • self-measured morning home systolic blood pressure (AM H-SBP)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-29.