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Reducing PM-associated CV Health Effects for Seniors

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ClinicalTrials.gov Identifier: NCT03334565
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Masako Morishita, 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases in Old Age Device: Low efficiency air filtration systems Device: High efficiency air filtration systems Device: Air filtration systems without filters (sham) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
Actual Study Start Date : October 21, 2014
Actual Primary Completion Date : November 4, 2016
Actual Study Completion Date : November 4, 2016

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)
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
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



Primary Outcome Measures :
  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 ]

Secondary Outcome Measures :
  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 ]
  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 ]
  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 ]
  4. microvasculature tone [ Time Frame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement ]


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Masako Morishita, Associate Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT03334565    
Other Study ID Numbers: R01NR014484 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases