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Not yet recruiting NCT07629518

Democratizing Access to Cleaner Residential Air

No phase Interventional Cardiovascular (CV) Risk

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: Portable air purifiers with HEPA filtration, Portable air purifiers without filtration (sham).
Who it may be relevant to
Registry conditions: Cardiovascular (CV) Risk. Basic parameters: from 40 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The purpose of this research study is to determine whether the use of in-home air filtration to reduce exposure to air pollution benefits health.

Detailed description

Conduct a randomized crossover pilot trial with 66 participants to calculate preliminary effect size estimates to inform a larger crossover efficacy trial:

We will: 1) enroll 66 individuals living in low and high traffic areas in Hartford (N=44) and a highly polluted urban areas in Boston Chinatown (N=22); and 2) install full filtration DIYAPs and sham DIYAPs for 30 days each in a randomized crossover trial design with a 14-day wash-out in between; and 3) measure seated and ambulatory BP, administer the SF-12v2, the Trail Making Test Part B, collect blood, and measure both indoor and outdoor PM (in size bins).

Interventions

  • Other Portable air purifiers with HEPA filtration
    Portable air purifiers filter air and reduce exposure to air pollutants, in this case, airborne particulate matter
  • Other Portable air purifiers without filtration (sham)
    Air purifiers with filters removed (sham)

Primary outcome measures

  • Blood pressure [Time frame: Day 0, 30, 45, and 75]
Secondary outcome measures (1)
  • IL-1beta [Time frame: Day 0, 30, 45, and 75]

Eligibility criteria

Inclusion criteria

Age 40 years or older Speaks English, Vietnamese, and/or Chinese Cognitive capacity to respond to questionnaires Lives fulltime at the current address, adjacent (< 200 meters) to roadways with large traffic volumes Must have one or more risk factors (hypertension or elevated blood pressure, pre-diabetes or diabetes or elevated blood sugar levels, elevated cholesterol levels, body mass index 25 or greater)

Exclusion criteria

Pregnant Works between the hours of 10 PM and 6 AM Sources of smoke in the living space (such as candles, incense, marijuana, wood stove, fireplace) almost every day/every day.

Every day exposure to motor vehicle exhaust (from cars, trucks, buses, trains), including heavy street or highway traffic.

Currently smoking or vaping Others smoking or vaping indoors, in the living space. Within the past 5 years, a diagnosis of heart attack, heart disease, stroke, blood clots or pulmonary embolism, cancer requiring surgery and/or chemo/radiation therapy

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07629518 · 25-285-2 · R34HL173375

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗