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Completed

NCT Number: NCT04103346

Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: air filtration

SHAM

Other

air purifier running with air filter removed

Other names: air purifier running with air filter removed

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 10 weeks

    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.

Secondary outcomes

  1. Diastolic Blood Pressure

    Time frame: 10 weeks

    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.

  2. Atmospheric Particulate Matter (pm2.5) - Indoor

    Time frame: 10 weeks

    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.

  3. Atmospheric Particulate Matter (pm2.5) - Outdoor

    Time frame: 10 weeks

    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.

  4. 24-hr Personal PM2.5 (Filter-gravimetric Mass)

    Time frame: 2 days

    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.

  5. Black Carbon, Hourly Personal PM2.5 Levels

    Time frame: 10 weeks

    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.

  6. Aortic Hemodynamics

    Time frame: 10 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.

  7. Insulin Sensitivity

    Time frame: 10 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.

  8. Adrenal Steroid Panel

    Time frame: 10 weeks

    Panel of hair, saliva, blood

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Acronym: RAPIDS2-Ypsi

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2019
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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