Reducing PM-associated CV Health Effects for Seniors
Reducing Particulate Matter-associated Cardiovascular 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.
Studie Overzicht
Toestand
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Sham-vergelijker: 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.
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Subjects were exposed to unfiltered air.
|
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Actieve vergelijker: 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.
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Subjects were exposed to low-efficiency filtered air.
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Actieve vergelijker: 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.
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Subjects were exposed to high-efficiency filtered air.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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brachial blood pressure
Tijdsspanne: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
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Brachial blood pressure was measured using a BPTru device.
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at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
noninvasive aortic hemodynamics
Tijdsspanne: 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.
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at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
|
Pulse wave velocity
Tijdsspanne: 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.
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at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
|
heart rate variability
Tijdsspanne: 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.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
|
microvasculature tone
Tijdsspanne: 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.
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at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R01NR014484 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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