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

Sponsor

NYU Langone Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05874479

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

440

Enrollment

Location

Arms

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Blood Pressure	Device: Active PAC Device: Sham PAC	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

440 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2027

Anticipated Study Completion Date :

Mar 1, 2028

Arms and Interventions

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

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

The active PAC will contain HEPA filters inside the device.

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

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

Outcome Measures

Primary Outcome Measures

Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days [Up to Day 30]
Participants measure HBP every day between 6-9 am.

Secondary Outcome Measures

Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days [Up to Day 90]
Participants measure HBP every day between 6-9 am.
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days [Up to Day 180]
Participants measure HBP every day between 6-9 am.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Jonathan Newman, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT05874479

Other Study ID Numbers:

23-00517

First Posted:

May 25, 2023

Last Update Posted:

May 25, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by NYU Langone Health

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

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of May 25, 2023