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.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Sham-komparator: 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.
|
Subjects were exposed to unfiltered air.
|
|
Aktiv komparator: 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.
|
Subjects were exposed to low-efficiency filtered air.
|
|
Aktiv komparator: 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.
|
Subjects were exposed to high-efficiency filtered air.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
brachial blood pressure
Tidsramme: 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.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
noninvasive aortic hemodynamics
Tidsramme: 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.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
|
Pulse wave velocity
Tidsramme: 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.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
|
heart rate variability
Tidsramme: 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
Tidsramme: 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.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R01NR014484 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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