Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

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

Detailed Description
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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.

Official Title
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Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

Conditions
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Cardiometabolic Health

Intervention / Treatment
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* Other: air filtration with air purifier with hepa filter
* Other: sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: air filtration with hepa filter<br>air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted. | Other: air filtration with air purifier with hepa filter<br>* long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.<br>* Other names: air filtration;|
| Sham Comparator: air filtration with hepa filter removed<br>sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed. | Other: sham<br>* air purifier running with air filter removed<br>* Other names: air purifier running with air filter removed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | Blood pressure taken in the morning (mm Hg) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atmospheric particulate matter (pm2.5) | Atmospheric particulate matter is measured in the units of ug/m3 and determined using a portable analyzer (PDR-1500) | 4 weeks | 
| 24-hr Blood Pressure | blood pressure response over 24 hours measured in the units mm Hg. | 4 weeks | 
| Nocturnal Blood Pressure | Blood pressure taken at night measured in the units mm Hg. | 4 weeks | 
| Aortic Hemodynamics | 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. | 4 weeks | 
| Insulin Sensitivity | 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. | 4 weeks | 
| Evening Blood Pressure | home bp taken in evening measured in the units mm Hg | 4 weeks | 
| Heart Rate Variability (HRV) | 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. | 4 weeks |