Reducing PM-associated CV Health Effects for Seniors

Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases in Old Age
• Intervention / Treatment: Device: Air filtration systems without filters (sham); Device: Low efficiency air filtration systems; Device: High efficiency air filtration systems

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Device: Air filtration systems without filters (sham); Subjects were exposed to unfiltered air.
Active Comparator: 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.	Device: Low efficiency air filtration systems; Subjects were exposed to low-efficiency filtered air.
Active Comparator: 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.	Device: High efficiency air filtration systems; Subjects were exposed to high-efficiency filtered air.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
brachial blood pressure	Brachial blood pressure was measured using a BPTru device.	at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
noninvasive aortic hemodynamics	Aortic hemodynamics was measured using a SphygmoCor device.	at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Pulse wave velocity	Pulse wave velocity was measured using a SphygmoCor device.	at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
heart rate variability	Heart rate variability was measured using a SphygmoCor device.	at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
microvasculature tone	Retinal photography was used to measure retinal arteriole diameters.	at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2014
• Primary Completion (Actual): November 4, 2016
• Study Completion (Actual): November 4, 2016

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: R01NR014484 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No