Cardiovascular Effects of Aerosols in Residences Study (CLEAR)

Simon Fraser University

Status and phase: Completed; Phase 2

Conditions: Systemic Inflammation; Endothelial Dysfunction

Treatments: Device: HEPA Filter; Device: HEPA Filtration Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01570062

Allen,R-MOP111042

Details and patient eligibility

About

This study is focused on the effects of HEPA filtration to reduce exposures to combustion-derived air pollution (CDAP). Specifically, the study will evaluate the health benefits of HEPA filters and compare the cardiovascular toxicity of two major sources of CDAP, specifically traffic and residential wood combustion.

Specifically, the purpose of this study is to evaluate the ability of portable high efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and air pollution indoors and to improve subclinical indicators of microvascular function and systemic inflammation among healthy adult participants.

The investigators hypothesize that HEPA filter use will help decrease indoor concentrations of CDAP thereby helping to mitigate the associated cardiovascular risks.

Full description

To address knowledge gaps about health risks of specific pollution sources and to provide new evidence on the health benefits of air pollution interventions, the objectives of this study are: 1) quantify the relationship between low-level exposures to combustion-derived PM air pollution and subclinical indicators of cardiovascular disease risk; and 2) compare the relative impact of HEPA filtration for two major PM sources (traffic and residential wood combustion) on these indicators.

The use of HEPA filters may help to mitigate cardiovascular risks factors caused by combustion-derived air pollution (CDAP), (specifically woodstove and traffic emissions). We hypothesize that HEPA filter use and improved woodstove technology will help decrease indoor occurrences of CDAP. This project will help address knowledge gaps in CDAP-related health risks and benefits of interventions. Specific objectives include establishing a relationship between exposure to CDAP and biomarkers of cardiovascular risk and evaluating the impact of HEPA filter use towards improved indoor air quality and health indicators.

Enrollment: 83 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 19 years or older
• non-smoking household
• lives within study boundaries and in areas of interest

Exclusion criteria

• COPD
• asthma
• diabetes
• heart disease
• hypertension
• arthritis
• gum disease
• occupationally exposed to traffic exposures &/or woodsmoke
• if female, pregnant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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83 participants in 2 patient groups, including a placebo group

Indoor Air HEPA Filtration

Active Comparator group

Description:

HEPA filters will be placed in participant's main living area and bedroom. Actual filtration will occur during only one of the two 7-day sampling periods.

Treatment:

Device: HEPA Filter

HEPA Filtration Placebo

Placebo Comparator group

Description:

For one of two 7-day sampling sessions, HEPA filters placed in participants' homes will be run without an actual filter in the housing unit.

Treatment:

Device: HEPA Filtration Placebo