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

NCT ID: NCT05874479

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2028-03-31

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.

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Active PAC

Intervention Type DEVICE

The active PAC will contain HEPA filters inside the 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.

Group Type SHAM_COMPARATOR

Sham PAC

Intervention Type DEVICE

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

Interventions

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Active PAC

The active PAC will contain HEPA filters inside the device.

Intervention Type DEVICE

Sham PAC

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Newman

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan Newman

Role: CONTACT

(212) 263-9393

Elle Anastasiou Pesante

Role: CONTACT

(646) 501-3613

Other Identifiers

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23-00517

Identifier Type: -

Identifier Source: org_study_id

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