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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01NR014484-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Michigan State University | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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Exposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| air filtration with hepa filter | Active Comparator | air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Brook, MD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41988923 | Derived | 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. |
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17 participants withdrew from the trial prior to randomization. Of the 35 participants who were randomized, data from 2 was not included in the analyses, because of external factors that rendered the data from those participants unusable.
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| ID | Title | Description |
|---|---|---|
| FG000 | Air Filtration With Hepa Filter, Then With Hepa Filter Removed | air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted, then with the filter removed following washout (sham comparator). 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. sham: air purifier running with air filter removed |
| FG001 | Air Filtration Without Hepa Filter, Then With Hepa Filter | sham comparator used the Holmes HAP8650B-NU-1 air purifier to be operated without the filter, then with the hepa filter installed following washout. 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. sham: air purifier running with air filter removed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 - 4 Weeks |
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| Washout - 2 Weeks |
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| Phase II - 4 Weeks |
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| ID | Title | Description |
|---|---|---|
| BG000 | Air Filtration With Hepa Filter, Then With Hepa Filter Removed | air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted, then with the filter removed following washout (sham comparator). 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. sham: air purifier running with air filter removed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm Hg | 10 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Air Filtration With Hepa Filter | air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geoff Barnes | University of Michigan | 734-763-0047 | gbarnes@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2021 | Oct 29, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 12, 2024 | Oct 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D061808 | Air Filters |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D005374 | Filtration |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D004864 | Equipment and Supplies |
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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
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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.
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| sham | Other | air purifier running with air filter removed |
|
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| 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 |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Air Filtration Without Hepa Filter, Then With Hepa Filter | sham comparator used the Holmes HAP8650B-NU-1 air purifier to be operated without the filter, then with the hepa filter installed following washout. 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. sham: air purifier running with air filter removed |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| History of coronary artery disease | Count of Participants | Participants |
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| History of cerebrovascular disease | Count of Participants | Participants |
|
| History of hyperlipidemia | Count of Participants | Participants |
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| History of hypertension | Count of Participants | Participants |
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| History of diabetes | Count of Participants | Participants |
|
| Blood Pressure Medication | Count of Participants | Participants |
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| Statin | Count of Participants | Participants |
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| Diabetes medication | Count of Participants | Participants |
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| Aspirin | Count of Participants | Participants |
|
sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.
sham: air purifier running with air filter removed
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm Hg | 10 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | (µg/m3) per day | 10 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | (µg/m3) per day | 10 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | µg/m3 per 24-hour period | 2 days |
|
|
|
|
| Secondary | 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. | This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected. | Posted | 10 weeks |
|
|
| Secondary | 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. | This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected. | Posted | 10 weeks |
|
|
| Secondary | 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. | This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected. | Posted | 10 weeks |
|
|
| Secondary | Adrenal Steroid Panel | Panel of hair, saliva, blood | This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected. | Posted | 10 weeks |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Air Filtration Without Hepa Filter | sham comparator used the Holmes HAP8650B-NU-1 air purifier operated without the filter. sham: air purifier running with air filter removed | 0 | 33 | 0 | 33 | 0 | 33 |
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