Clinical trial NCT04103346: Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
Official title: Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Health
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan State University
name: National Institute of Nursing Research (NINR)
First posted: 2019-09-25
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: crossover of active filtration in subject's residence with a home filtration unit (Holmes air filtration unit Model HAP8650B-NU-1) versus an inactive sham filtration
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: Atmospheric particulate matter (pm2.5)
timeFrame: 4 weeks
measure: 24-hr Blood Pressure
timeFrame: 4 weeks
measure: Nocturnal Blood Pressure
timeFrame: 4 weeks
measure: Aortic Hemodynamics
timeFrame: 4 weeks
measure: Insulin Sensitivity
timeFrame: 4 weeks
measure: Evening Blood Pressure
timeFrame: 4 weeks
measure: Heart Rate Variability (HRV)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Wayne State University
name: Robert Brook, MD
role: PRINCIPAL_INVESTIGATOR
References: