Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents (AirPressureNYC)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jonathan Newman
- Phone Number: (212) 263-9393
- Email: AirPressureNYC@nyulangone.org
Study Contact Backup
- Name: Elle Anastasiou Pesante
- Phone Number: (646) 501-3613
- Email: elle.anastasiou@nyulangone.org
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
|
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.
|
The sham PAC will contain no HEPA filters inside the device.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days
Time Frame: Up to Day 30
|
Participants measure HBP every day between 6-9 am.
|
Up to Day 30
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days
Time Frame: Up to Day 90
|
Participants measure HBP every day between 6-9 am.
|
Up to Day 90
|
|
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days
Time Frame: Up to Day 180
|
Participants measure HBP every day between 6-9 am.
|
Up to Day 180
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Jonathan Newman, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 23-00517
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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