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OpenTrials
Completed

NCT Number: NCT03334565

Reducing PM-associated CV 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.

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Key information

Conditions

Cardiovascular Diseases in Old Age

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low efficiency air filtration systems

Device

Subjects were exposed to low-efficiency filtered air.

High efficiency air filtration systems

Device

Subjects were exposed to high-efficiency filtered air.

Air filtration systems without filters (sham)

Device

Subjects were exposed to unfiltered air.

Primary outcomes

  1. brachial blood pressure

    Time frame: 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 outcomes

  1. noninvasive aortic hemodynamics

    Time frame: 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.

  2. Pulse wave velocity

    Time frame: 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.

  3. heart rate variability

    Time frame: 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.

  4. microvasculature tone

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • University of Michigan

Registry information

Official study title

Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 7, 2017
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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