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

NCT05874479 | Recruiting DMC

• 1 other identifier: 23-00517
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Active Portable Air Cleaner (PAC)

EXPERIMENTAL

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 PAC

SHAM COMPARATOR

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

Interventions

Active PAC DEVICE

The active PAC will contain HEPA filters inside the device.

Active Portable Air Cleaner (PAC)

Sham PAC DEVICE

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

Sham PAC

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-reported nonsmokers living in a nonsmoking household.
• adults living with hypertension (HTN) from NYC public housing.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• Jonathan Newman

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Newman

CONTACT

(212) 263-9393; AirPressureNYC@nyulangone.org

Elle Anastasiou Pesante

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 25, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Jonathan.newman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)