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Reducing PM-associated CV Health Effects for Seniors

Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03334565
Enrollment
40
Registered
2017-11-07
Start date
2014-10-21
Completion date
2016-11-04
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases in Old Age

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.

Interventions

DEVICELow efficiency air filtration systems

Subjects were exposed to low-efficiency filtered air.

DEVICEHigh efficiency air filtration systems

Subjects were exposed to high-efficiency filtered air.

DEVICEAir filtration systems without filters (sham)

Subjects were exposed to unfiltered air.

Sponsors

University of Michigan
CollaboratorOTHER
Michigan State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
brachial blood pressureat the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placementBrachial blood pressure was measured using a BPTru device.

Secondary

MeasureTime frameDescription
noninvasive aortic hemodynamicsat the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placementAortic hemodynamics was measured using a SphygmoCor device.
Pulse wave velocityat the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placementPulse wave velocity was measured using a SphygmoCor device.
heart rate variabilityat the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placementHeart rate variability was measured using a SphygmoCor device.
microvasculature toneat the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placementRetinal photography was used to measure retinal arteriole diameters.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026