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

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

Study Overview

• Status: Completed
• Conditions: Cardiometabolic Health
• Intervention / Treatment: Other: air filtration with air purifier with hepa filter; Other: sham

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: air filtration with hepa filter; air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted.	Other: air filtration with air purifier with hepa filter; 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.; Other Names: air filtration
Sham Comparator: air filtration with hepa filter removed; sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.	Other: sham; air purifier running with air filter removed; Other Names: air purifier running with air filter removed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Systolic blood pressure was measured twice a day, in the morning and the evening, from Tuesday through Friday during the first and fourth week of each of the four-week periods in which participants were exposed to one of the interventions. Results reflect the average of systolic readings taken.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure	Diastolic blood pressure was measured twice a day, in the morning and the evening, from Tuesday through Friday during the first and fourth week of each of the four-week periods in which participants were exposed to one of the interventions. Results reflect the average of diastolic readings taken.	10 weeks
Atmospheric Particulate Matter (pm2.5) - Indoor	Atmospheric particulate matter was measured daily in the units of ug/m3 and determined using a portable analyzer (PDR-1500). Results reflect the average amount of atmospheric particulate matter present per day.	10 weeks
Atmospheric Particulate Matter (pm2.5) - Outdoor	Atmospheric particulate matter was measured daily in units of ug/m3 and determined using a portable analyzer (PDR-1500). Results reflect the average amount of atmospheric particulate matter present per day.	10 weeks
24-hr Personal PM2.5 (Filter-gravimetric Mass)	PM2.5 mass measured from the filters contained in the personal particulate monitors worn for 24-hours by participants performed on the last week of each cross-over limb (twice per participant in total). 24-hour data collection for personal PM2.5 exposure was collected from Thursday morning at 9 am to Friday morning at 9 am during trial week 4 and during trial week 10.	2 days
Black Carbon, Hourly Personal PM2.5 Levels	Evaluation of the effect of active vs sham filtration on lowering black carbon levels and hourly levels of PM2.5 throughout a 24-hour period.	10 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.	10 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.	10 weeks
Adrenal Steroid Panel	Panel of hair, saliva, blood	10 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Nursing Research (NINR); Michigan State University
• Investigators: Principal Investigator: Robert Brook, MD, Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Equipment and Supplies; Filtration; Chemistry Techniques, Analytical; Air Filters; salicylhydroxamic acid
• Other Study ID Numbers: HUM00156608; 2R01NR014484-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No