Home Air Filtration for Traffic-Related Air Pollution

NCT04279249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2024-11-01

No results posted yet for this study

Summary

This study is a blinded randomized crossover efficacy trial (N=172 households consisting of 207 participants) of High Efficiency Particulate Air (HEPA) filtration in near-highway homes that lack mechanical air-handling systems. Households will be randomized to 30 days of either filtration or sham filtration followed by a 30 washout period with a subsequent 30-day period of the alternative assignment. Room air filters that are commercially available will be placed in the bedroom and living room of each home.

The investigators will measure UFP and PM2.5 concentrations in 20% of the homes during filtration and sham periods and assess personal exposure in a subset of participants. The investigators will also assess chemical composition of particulate air pollution in 10 homes/year for exploratory purposes that could lead to future lines of research. The primary health endpoints will be participants' hsCRP and peripheral blood pressure, measures that the investigators have used in multiple observational studies of UFP as well as in pilot filtration intervention studies. Secondary biological measures that contribute to understanding biological pathways will be IL-6 (inflammation), D-dimer (coagulation), metabolome, central pressure and arterial stiffness. The primary intention to treat analysis will compare outcomes between HEPA filtration to sham filtration. The investigators will have 80% power to detect a difference of 0.6 mg/L in change in hsCRP and a difference in reduction in systolic blood pressure of 3.5 mmHg compared to participants who receive no filtration. Having participants serve as their own controls in the within-subject comparisons of intervention effectiveness increases statistical power and eliminates the possibility of baseline imbalances in demographic and clinical characteristics. A social science evaluation will inform final adjustments to the investigators' approach at the start and also assess participant acceptance and experience with the intervention at the end. The investigators' primary innovation is that this will be the first near highway HEPA intervention trial that is large enough and careful enough to be policy-relevant.

Conditions

  • Cardiovascular Risk Factor
  • Blood Pressure

Interventions

OTHER

HEPA Air Filtration

2 HEPA air filters placed in home (one in bedroom, one in living room) for 30 days

OTHER

Sham HEPA Air Filtration

2 HEPA air filter devices with filter removed placed in home (one in bedroom, one in living room) for 30 days

Sponsors & Collaborators

  • Somerville Transportation Equity Partnership, Inc.

    collaborator UNKNOWN
  • Tufts University

    collaborator OTHER
  • Olin College of Engineering

    collaborator UNKNOWN
  • Welcome Project Inc

    collaborator UNKNOWN
  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH
  • UConn Health

    lead OTHER

Principal Investigators

  • Doug Brugge, PhD · Tufts University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04279249 on ClinicalTrials.gov