Reducing PM-associated CV Health Effects for Seniors

NCT ID: NCT03334565

Last Updated: 2020-10-22

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-21

Study Completion Date

2016-11-04

Brief Summary

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The objective of this study is to investigate the effectiveness of air filtration at reducing personal-level exposures to fine particulate matter (PM2.5) and mitigating related cardiovascular (CV) health effects among older adults in a residential facility in a representative US urban location.

We enrolled 40 nonsmoking older adults into a randomized double-blind crossover intervention study with daily CV health outcomes and PM2.5 exposure measurements. The study was conducted in a low-income senior living apartment building in downtown Detroit, Michigan.

Participants were exposed to three 3-day scenarios separated by one-week washout periods: unfiltered ambient air (control), low-efficiency (LE) "HEPA-type", and high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence.

The primary outcome was brachial blood pressure (BP). Secondary outcomes included noninvasive aortic hemodynamics and pulse wave velocity and heart rate variability. PM2.5 exposures were measured in the participants' residences as well as by personal-level monitoring.

Detailed Description

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Conditions

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Cardiovascular Diseases in Old Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sham

Participants were exposed to unfiltered ambient air (sham) filtered air using air filtration systems in the bedroom and main living space of each residence.

Group Type SHAM_COMPARATOR

Air filtration systems without filters (sham)

Intervention Type DEVICE

Subjects were exposed to unfiltered air.

Low efficiency

Participants were exposed to low-efficiency (LE) "HEPA-type" filtered air using air filtration systems in the bedroom and main living space of each residence.

Group Type ACTIVE_COMPARATOR

Low efficiency air filtration systems

Intervention Type DEVICE

Subjects were exposed to low-efficiency filtered air.

High efficiency

Participants were exposed to high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence.

Group Type ACTIVE_COMPARATOR

High efficiency air filtration systems

Intervention Type DEVICE

Subjects were exposed to high-efficiency filtered air.

Interventions

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Low efficiency air filtration systems

Subjects were exposed to low-efficiency filtered air.

Intervention Type DEVICE

High efficiency air filtration systems

Subjects were exposed to high-efficiency filtered air.

Intervention Type DEVICE

Air filtration systems without filters (sham)

Subjects were exposed to unfiltered air.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 50 to 85 years old
* non-smoking healthy adults

Exclusion Criteria

* smoke or anyone in your residence smokes.
* had a cardiovascular event within the past 6 months (such as myocardial infarction (heart attack), angina, cardiac or carotid surgery or stent, diagnosed peripheral arterial disease, aortic aneurysms, treated heart failure, any treated arrhythmia including atrial fibrillation)
* have renal disease requiring dialysis.
* have had medication changes in the past 6 weeks.
* use supplementary oxygen.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Masako Morishita

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Morishita M, Adar SD, D'Souza J, Ziemba RA, Bard RL, Spino C, Brook RD. Effect of Portable Air Filtration Systems on Personal Exposure to Fine Particulate Matter and Blood Pressure Among Residents in a Low-Income Senior Facility: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1350-1357. doi: 10.1001/jamainternmed.2018.3308.

Reference Type DERIVED
PMID: 30208394 (View on PubMed)

Other Identifiers

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R01NR014484

Identifier Type: NIH

Identifier Source: org_study_id

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