Reducing PM-associated CV Health Effects for Seniors

Not Applicable

Completed

• Conditions: Cardiovascular Diseases in Old Age
• Interventions: Device: High efficiency air filtration systems; Device: Air filtration systems without filters (sham); Device: Low efficiency air filtration systems

• Registration Number: NCT03334565
• Lead Sponsor: Michigan State University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-10-21
• Primary Completion: 2016-11-04
• Study Completion: 2016-11-04
• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High efficiency	High efficiency air filtration systems	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.
Sham	Air filtration systems without filters (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.
Low efficiency	Low efficiency air filtration systems	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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