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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05874479
Other study ID # 23-00517
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 20, 2023
Est. completion date March 2028

Study information

Verified date December 2023
Source NYU Langone Health
Contact Jonathan Newman
Phone (212) 263-9393
Email AirPressureNYC@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 440
Est. completion date March 2028
Est. primary completion date September 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Active PAC
The active PAC will contain HEPA filters inside the device.
Sham PAC
The sham PAC will contain no HEPA filters inside the device.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days Participants measure HBP every day between 6-9 am. Up to Day 90
Secondary Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days Participants measure HBP every day between 6-9 am. Up to Day 180
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