Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

Not Applicable

Completed

• Conditions: Cardiometabolic Health
• Interventions: Other: sham; Other: air filtration with air purifier with hepa filter

• Registration Number: NCT04103346
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-25
• Study Start: 2020-02-24
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
air filtration with hepa filter removed	sham	sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.
air filtration with hepa filter	air filtration with air purifier with hepa filter	air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted.

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	4 weeks	Blood pressure taken in the morning (mm Hg)

Secondary Outcome Measures

Name	Time	Method
Nocturnal Blood Pressure	4 weeks	Blood pressure taken at night measured in the units mm Hg.
Atmospheric particulate matter (pm2.5)	4 weeks	Atmospheric particulate matter is measured in the units of ug/m3 and determined using a portable analyzer (PDR-1500)
24-hr Blood Pressure	4 weeks	blood pressure response over 24 hours measured in the units mm Hg.
Aortic Hemodynamics	4 weeks	Determined using pulse wave analyses of the augmentation index calculated as the height of the reflected wave as a percentage of the total height of the ascending aortic pressure wave.
Heart Rate Variability (HRV)	4 weeks	A reduction in time domain, standard deviation of all normal RR intervals (SDNN) will serve as the usual primary outcome for studies, as it has been directly linked with a worse CV prognosis.
Evening Blood Pressure	4 weeks	home bp taken in evening measured in the units mm Hg
Insulin Sensitivity	4 weeks	To determine the impact of reduced particulate matter on insulin sensitivity, determined by measuring insulin and glucose to calculate the homeostasis model assessment of insulin resistance (HOMA-IR) metric.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States