Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

NCT04103346 | Completed Results DMC

• 2 other identifiers: HUM001566082R01NR014484-06
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiometabolic Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Diastolic Blood Pressure

  10 weeks

• Atmospheric Particulate Matter (pm2.5) - Indoor

  10 weeks

• Atmospheric Particulate Matter (pm2.5) - Outdoor

  10 weeks

• 24-hr Personal PM2.5 (Filter-gravimetric Mass)

  2 days

• Black Carbon, Hourly Personal PM2.5 Levels

  10 weeks

Study Arms (2)

air filtration with hepa filter

ACTIVE COMPARATOR

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

Other: air filtration with air purifier with hepa filter

air filtration with hepa filter removed

SHAM COMPARATOR

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

Other: sham

Interventions

sham OTHER

air purifier running with air filter removed

Also known as: air purifier running with air filter removed

air filtration with hepa filter removed

air filtration with air purifier with hepa filter OTHER

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.

Also known as: air filtration

air filtration with hepa filter

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Michigan State University: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

MeSH Terms

Interventions

Air Filters; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Equipment and Supplies

Results Point of Contact

• Title: Geoff Barnes
• Organization: University of Michigan

gbarnes@med.umich.edu

734-763-0047

Study Officials

• Robert Brook, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: filtration units with or without filters. filters are placed by research assistant from the environmental college and researchers performing the health outcomes are blinded to the condition (sham or active filtration) along with the subject.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Model Details: 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

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 25, 2019
• Study Start: February 24, 2020
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)