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

Primary Purpose

Blood Pressure

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active PAC
Sham PAC
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Pressure focused on measuring self-measured morning home systolic blood pressure (AM H-SBP)

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Portable Air Cleaner (PAC)

Sham PAC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days
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
Participants measure HBP every day between 6-9 am.
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days
Participants measure HBP every day between 6-9 am.

Full Information

First Posted
May 12, 2023
Last Updated
June 15, 2023
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05874479
Brief Title
Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents
Acronym
AirPressureNYC
Official Title
Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure
Keywords
self-measured morning home systolic blood pressure (AM H-SBP)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Portable Air Cleaner (PAC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham PAC
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active PAC
Intervention Description
The active PAC will contain HEPA filters inside the device.
Intervention Type
Device
Intervention Name(s)
Sham PAC
Intervention Description
The sham PAC will contain no HEPA filters inside the device.
Primary Outcome Measure Information:
Title
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days
Description
Participants measure HBP every day between 6-9 am.
Time Frame
Up to Day 30
Secondary Outcome Measure Information:
Title
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days
Description
Participants measure HBP every day between 6-9 am.
Time Frame
Up to Day 90
Title
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days
Description
Participants measure HBP every day between 6-9 am.
Time Frame
Up to Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Newman
Phone
(212) 263-9393
Email
AirPressureNYC@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Newman
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Jonathan.newman@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing 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.
IPD Sharing 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.

Learn more about this trial

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

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