Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors (RAPIDS2-Ypsi)

University of Michigan

Status: Completed

Conditions: Cardiometabolic Health

Treatments: Other: sham; Other: air filtration with air purifier with hepa filter

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04103346

2R01NR014484-06 (U.S. NIH Grant/Contract)

HUM00156608

Details and patient eligibility

About

Exposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity.

Full description

This is a randomized double-blind placebo-controlled (sham filtration) crossover trial comparing the effectiveness bedroom-only portable indoor air filtration units [AFUs] to reduce personal PM2.5 exposures and improve cardiometabolic health. The health benefits (primary outcome: resting BP) will be evaluated over acute (4-day) and long-term (4-week) periods in 50 nonsmoking elderly adults living in a senior facility impacted by near-roadway pollutants.

Because of COVID-19 restrictions that occurred during the trial, certain outcome measures were removed from the protocol, as they could not be performed: 24-hr Blood Pressure, Heart Rate Variability (HRV), BpTRU BP measurements, and WatchPAT. Other outcome measures were not removed from the protocol, but data could not be collected for them because of COVID restrictions.

Enrollment: 52 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nonsmoker
• ≥60 years old
• residing in Carpenter Place Apartments

Exclusion criteria

• Active cigarette smoker
• daily secondhand smoke exposure (self-report)
• any CV event (myocardial infarction, stroke, heart failure, revascularization) in the past 3 months
• unstable CV condition or risk factor (uncontrolled diabetes, class 3-4 angina or heart failure) or any medical condition that would place the participant at risk from participation or jeopardize study integrity (per investigators)
• expected overnight travel outside their apartment during the 14-week study period
• unable to provide informed consent
• lung disease requiring oxygen
• renal dialysis
• cancer receiving active treatment or chemotherapy
• severe uncontrolled high BP ≥160/100 mm Hg or SBP<115 mm Hg.
• CV medication change in the prior month. If participants are on medications for high BP, diabetes, or a CV condition, they will need to have stable therapy during the prior month with no planned changes during the study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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52 participants in 2 patient groups

air filtration with hepa filter

Active Comparator group

Description:

air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted.

Treatment:

Other: air filtration with air purifier with hepa filter

air filtration with hepa filter removed

Sham Comparator group

Description:

sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.

Treatment:

Other: sham