Cardiometabolic HealthRAPIDS2-YpsiNCT04103346
Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
A study testing air filtration with air purifier with hepa filter in people with Cardiometabolic Health, run by University of Michigan at 1 site in United States.
Trial summary
Exposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Health
- What is being tested?
- air filtration with air purifier with hepa filter
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nonsmoker
- ≥60 years old
- residing in Carpenter Place Apartments
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Exposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity.
Read the 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.
- Conditions
- Cardiometabolic Health
- Being tested
- air filtration with air purifier with hepa filter, sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air filtration with air purifier with hepa filterOther
Also called air filtration
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.
shamOther
Also called air purifier running with air filter removed
air purifier running with air filter removed
| Study group | Role | What they receive |
|---|---|---|
| air filtration with hepa filter | Active comparator | air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted. Receives: 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. Receives: Other: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Adrenal Steroid Panel
Panel of hair, saliva, blood
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start24 Feb 2020
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic HealthStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Geoffrey Barnes, University of Michigan
- Investigators
- Robert Brook, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103346
- Sponsor's protocol ID
- HUM00156608
- Other IDs
- 2R01NR014484-06
- Acronym
- RAPIDS2-Ypsi
- Status last verified
- Dec 2025
- First submitted
- 18 Sep 2019
- Last updated
- 16 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brook RD, Song Y, Bard RL, Wang L, Klaver ZM, Ziemba RA, Barnes GD, Brook AJ, Keilman L, Morishita M. Bedroom Air Filtration and Home Blood Pressures of Older Adults Living in a Residential Facility. J Clin Hypertens (Greenwich). 2026 Apr;28(4):e70251. doi: 10.1111/jch.70251.
PubMed 41988923
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
- ClinicalTrials.gov ID
- NCT04103346
- Acronym / sponsor ID
- RAPIDS2-Ypsi / HUM00156608
- Conditions
- Cardiometabolic Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan State University, National Institute of Nursing Research (NINR)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Posted 16 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| air filtration with hepa filter | Active comparator | Other: air filtration with air purifier with hepa filterair purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted. |
| air filtration with hepa filter removed | Sham comparator | Other: shamsham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nonsmoker
- ≥60 years old
- residing in Carpenter Place Apartments
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| air filtration with air purifier with hepa filterAlso: air filtrationlong-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 | air filtration with hepa filter |
| shamAlso: air purifier running with air filter removedair purifier running with air filter removed | Other | air filtration with hepa filter removed |
Primary outcome
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.
8 secondary outcomes
Diastolic Blood Pressure
Time frame: 10 weeks
Atmospheric Particulate Matter (pm2.5) - Indoor
Time frame: 10 weeks
Atmospheric Particulate Matter (pm2.5) - Outdoor
Time frame: 10 weeks
24-hr Personal PM2.5 (Filter-gravimetric Mass)
Time frame: 2 days
Black Carbon, Hourly Personal PM2.5 Levels
Time frame: 10 weeks
Aortic Hemodynamics
Time frame: 10 weeks
Insulin Sensitivity
Time frame: 10 weeks
Adrenal Steroid Panel
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41988923Brook RD, Song Y, Bard RL, Wang L, Klaver ZM, Ziemba RA, Barnes GD, Brook AJ, Keilman L, Morishita M. Bedroom Air Filtration and Home Blood Pressures of Older Adults Living in a Residential Facility. J Clin Hypertens (Greenwich). 2026 Apr;28(4):e70251. doi: 10.1111/jch.70251.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Brook, MD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing air filtration with air purifier with hepa filter in people with Cardiometabolic Health, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04103346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.