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Recruiting NCT05874479

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

No phase Interventional Blood Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active PAC, Sham PAC.
Who it may be relevant to
Registry conditions: Blood Pressure. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days [Time frame: Up to Day 30]
Secondary outcome measures (2)
  • Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days [Time frame: Up to Day 90]
  • Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days [Time frame: Up to Day 180]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT05874479 · 23-00517

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗