Reducing PM-associated CV Health Effects for Seniors

Study Overview
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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.

Official Title
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Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

Conditions
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Cardiovascular Diseases in Old Age

Intervention / Treatment
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* Device: Low efficiency air filtration systems
* Device: High efficiency air filtration systems
* Device: Air filtration systems without filters (sham)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham<br>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)<br>* Subjects were exposed to unfiltered air.<br>|
| Active Comparator: Low efficiency<br>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<br>* Subjects were exposed to low-efficiency filtered air.<br>|
| Active Comparator: High efficiency<br>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<br>* Subjects were exposed to high-efficiency filtered air.<br>|

What is the study measuring?
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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 |