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Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

NCT ID: NCT04103346

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-24

Study Completion Date

2024-11-01

Brief Summary

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Exposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity.

Detailed Description

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This is a randomized double-blind placebo-controlled (sham filtration) crossover trial comparing the effectiveness bedroom-only portable indoor air filtration units \[AFUs\] to reduce personal PM2.5 exposures and improve cardiometabolic health. The health benefits (primary outcome: resting BP) will be evaluated over acute (4-day) and long-term (4-week) periods in 50 nonsmoking elderly adults living in a senior facility impacted by near-roadway pollutants.

Conditions

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Cardiometabolic Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

crossover of active filtration in subject's residence with a home filtration unit (Holmes air filtration unit Model HAP8650B-NU-1) versus an inactive sham filtration
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
filtration units with or without filters. filters are placed by research assistant from the environmental college and researchers performing the health outcomes are blinded to the condition (sham or active filtration) along with the subject.

Study Groups

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air filtration with hepa filter

air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted.

Group Type ACTIVE_COMPARATOR

air filtration with air purifier with hepa filter

Intervention Type OTHER

long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.

air filtration with hepa filter removed

sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.

Group Type SHAM_COMPARATOR

sham

Intervention Type OTHER

air purifier running with air filter removed

Interventions

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air filtration with air purifier with hepa filter

long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.

Intervention Type OTHER

sham

air purifier running with air filter removed

Intervention Type OTHER

Other Intervention Names

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air filtration air purifier running with air filter removed

Eligibility Criteria

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Inclusion Criteria

* Nonsmoker
* ≥60 years old
* residing in Carpenter Place Apartments

Exclusion Criteria

* Active cigarette smoker
* daily secondhand smoke exposure (self-report)
* any CV event (myocardial infarction, stroke, heart failure, revascularization) in the past 3 months
* unstable CV condition or risk factor (uncontrolled diabetes, class 3-4 angina or heart failure) or any medical condition that would place the participant at risk from participation or jeopardize study integrity (per investigators)
* expected overnight travel outside their apartment during the 14-week study period
* unable to provide informed consent
* lung disease requiring oxygen
* renal dialysis
* cancer receiving active treatment or chemotherapy
* severe uncontrolled high BP ≥160/100 mm Hg or SBP\<115 mm Hg.
* CV medication change in the prior month. If participants are on medications for high BP, diabetes, or a CV condition, they will need to have stable therapy during the prior month with no planned changes during the study period.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Michigan State University

OTHER

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Geoffrey Barnes

Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Brook, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2R01NR014484-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00156608

Identifier Type: -

Identifier Source: org_study_id