HEPA Filters for Cardiometabolic Health
Recruiting in Palo Alto (17 mi)
Overseen byZhanghua Chen, PhD
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Southern California
Disqualifiers: Diabetes, Alzheimer's, Cancer, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this randomized, double-blind, crossover trial is to test the hypothesis that a longer-term indoor HEPA filtration intervention can improve cardiometabolic profiles by reducing indoor PM2.5 exposures in at-risk individuals.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of HEPA filters as a treatment for cardiometabolic health?
Research shows that reducing exposure to fine particulate matter (tiny particles in the air) with air cleaners can improve heart health. A study called the Cardiac Rehabilitation Air Filter Trial (CRAFT) tested air cleaners in heart patients and found potential health benefits.
12345How does the HEPA filter treatment for cardiometabolic health differ from other treatments?
The HEPA filter treatment is unique because it focuses on reducing exposure to fine particulate matter (tiny particles in the air) by filtering indoor air, which may help improve cardiovascular health. Unlike traditional treatments that might involve medication or lifestyle changes, this approach uses air filtration to potentially lower the risk of heart-related issues by improving air quality.
46789Eligibility Criteria
This trial is for people aged 65-84 living in Los Angeles County who are overweight (BMI ≥ 25 kg/m2 historically), non-smokers for at least a year, have Wi-Fi at home, and speak English or Spanish. It's not for those with active cancer treatment, plans to move soon, certain health conditions, homes unsuitable for air purifiers or already equipped with HEPA filters.Inclusion Criteria
I am between 65 and 84 years old.
Nonsmoker for at least 1 year
History of BMI ≥ 25 kg/m2 in the past based on EMR information
+2 more
Exclusion Criteria
Have high blood glucose from finger stick test (> 200 mg/dL)
I am currently undergoing treatment for cancer.
The residential house has already had HEPA filters
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
HEPA Intervention
Participants receive HEPA filters to reduce PM2.5 levels at their residence for 6 months
6 months
Multiple home visits for setup and data collection
Wash-out
A 6-month wash-out period where no intervention is applied
6 months
Sham Intervention
Participants receive sham filters without the capacity to reduce PM2.5 levels for 6 months
6 months
Multiple home visits for setup and data collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if using HEPA filters in the home can improve heart and metabolic health by reducing fine particle pollution indoors. Participants will be randomly assigned to use either a real HEPA filter or a fake one without knowing which they have.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HEPA first and shamExperimental Treatment2 Interventions
This group of participants will be assigned an intervention of HEPA filters with the capacity to reduce PM2.5 levels at their residence for 6 months. After 6-month wash-out period, will be assigned to sham filters for 6 months.
Group II: Sham first and HEPAPlacebo Group2 Interventions
This group of participants will be assigned an intervention of sham filters without the capacity to reduce PM2.5 levels at their residence for 6 months. After 6-month wash-out period, will be assigned to HEPA filters for 6 months.
HEPA filter is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as HEPA filter for:
- Air purification for reducing PM2.5 exposures
- Improvement of cardiometabolic health
🇪🇺 Approved in European Union as HEPA filter for:
- Air purification for reducing PM2.5 exposures
- Improvement of cardiometabolic health
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Keck School of Medicine, University of Southern CaliforniaLos Angeles, CA
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Who Is Running the Clinical Trial?
University of Southern CaliforniaLead Sponsor
Duke UniversityCollaborator
References
Reduced Fine Particulate Matter Air Pollution Exposures Using In-Home Portable Air Cleaners: PILOT RESULTS OF THE CARDIAC REHABILITATION AIR FILTER TRIAL (CRAFT). [2021]Fine particulate matter (PM2.5) air pollution is a leading risk factor for cardiovascular disease. Even low levels common to millions of Americans pose health risks. However, no study has tested protective measures such as in-home portable air cleaners (PACs) among at-risk cardiac patients. We conducted a pilot phase of the Cardiac Rehabilitation Air Filter Trial (CRAFT)-a randomized, double-blind, crossover study of outpatient cardiac rehabilitation patients at Michigan Medicine.
Air pollution and hospital admissions for ischemic and hemorrhagic stroke among medicare beneficiaries. [2016]The association between short-term elevations in ambient air particles and increased cardiovascular morbidity and mortality is well documented. Ambient particles may similarly increase the risk of stroke.
Cardiopulmonary Impact of Particulate Air Pollution in High-Risk Populations: JACC State-of-the-Art Review. [2023]Fine particulate air pollution <2.5 μm in diameter (PM2.5) is a major environmental threat to global public health. Multiple national and international medical and governmental organizations have recognized PM2.5 as a risk factor for cardiopulmonary diseases. A growing body of evidence indicates that several personal-level approaches that reduce exposures to PM2.5 can lead to improvements in health endpoints. Novel and forward-thinking strategies including randomized clinical trials are important to validate key aspects (e.g., feasibility, efficacy, health benefits, risks, burden, costs) of the various protective interventions, in particular among real-world susceptible and vulnerable populations. This paper summarizes the discussions and conclusions from an expert workshop, Reducing the Cardiopulmonary Impact of Particulate Matter Air Pollution in High Risk Populations, held on May 29 to 30, 2019, and convened by the National Institutes of Health, the U.S. Environmental Protection Agency, and the U.S. Centers for Disease Control and Prevention.
Mitigation of Aerosols Generated During Exercise Testing With a Portable High-Efficiency Particulate Air Filter With Fume Hood. [2021]The role of portable high-efficiency particulate air (HEPA) filters for supplemental aerosol mitigation during exercise testing is unknown and might be relevant during COVID-19 pandemic.
Effects of reducing exposure to air pollution on submaximal cardiopulmonary test in patients with heart failure: Analysis of the randomized, double-blind and controlled FILTER-HF trial. [2022]Air pollution exposure could mitigate the health benefits of exercise in patients with heart failure (HF). We tested the effects of a respiratory filter on HF patients exposed to air pollution during exercise.
Reduction of personal PM2.5 exposure via indoor air filtration systems in Detroit: an intervention study. [2021]The adverse health effects of fine particulate matter (PM < 2.5 μm in diameter [PM2.5]) air pollution are well-documented. There is a growing body of evidence that high-efficiency particulate arrestance (HEPA) filtration can reduce indoor PM2.5 concentrations and deliver some health benefits via the reduction of exposure to PM. However, few studies have tested the ability of portable air filtration systems to lower overall personal-level PM2.5 exposures. The Reducing Air Pollution in Detroit Intervention Study (RAPIDS) was designed to evaluate cardiovascular health benefits and personal PM2.5 exposure reductions via indoor portable air filtration systems among senior citizens in Detroit, Michigan. We evaluated the utility of two commercially available high-efficiency (HE: true-HEPA) and low-efficiency (LE: HEPA-type) indoor air filtration to reduce indoor PM2.5 concentrations and personal PM2.5 exposures for 40 participants in a double-blinded randomized crossover intervention. Each participant was subjected to three intervention scenarios: HE, LE, or no filter (control) of three consecutive days each, during which personal, indoor, and outdoor PM2.5 concentrations were measured daily. For mean indoor PM2.5 concentrations, we observed 60 and 52% reductions using HE and LE filters, respectively, relative to no filtration. Personal PM2.5 exposures were reduced by 53 and 31% using HE and LE filters, respectively, when compared with the control scenario. To our knowledge, this is the first indoor air filtration intervention study to examine the effectiveness of both HE and LE filters in reducing personal PM2.5 exposures.
Assessment of the capacity of vehicle cabin air inlet filters to reduce diesel exhaust-induced symptoms in human volunteers. [2022]Exposure to particulate matter (PM) air pollution especially derived from traffic is associated with increases in cardiorespiratory morbidity and mortality. In this study, we evaluated the ability of novel vehicle cabin air inlet filters to reduce diesel exhaust (DE)-induced symptoms and markers of inflammation in human subjects.
High-performance inertial impaction filters for particulate matter removal. [2023]Airborne particulate matter (PM) is causing more and more serious air pollution and threatening the public health. However, existing air filter technologies with the easy-to-block manner can rarely meet the requirements of high-performance PM filters. Here we propose a conceptually new type of inertial impaction filters for rapidly high-efficiency PM removal. Under the airflow velocity of 8.0 m/s, the real inertial impaction filters show high PM removal efficiencies of up to 97.77 ± 1.53% and 99.47 ± 0.45% for PM2.5 and PM10, respectively. Compared with the traditional air filters reported previously, the inertia impaction filters exhibit extremely low pressure drop of 5-10 Pa and high quality factor (QF) values of 0.380 Pa-1 and 0.524 Pa-1 for PM2.5 and PM10, respectively. These greatly improved QF values are achieved through a series of inertial separation processes. The feature dimension of filtration channel is dozens of times larger than PM average size, which greatly decreases airflow resistance. Particularly, this inertial structure can be made of various types of materials, which shows great potential for low-cost fabrication of large-area devices. As a stand-alone device or incorporated with the existing PM air filter, this inertial impaction filter will bring great benefits to the public health.
Health benefits of particle filtration. [2022]The evidence of health benefits of particle filtration in homes and commercial buildings is reviewed. Prior reviews of papers published before 2000 are summarized. The results of 16 more recent intervention studies are compiled and analyzed. Also, reviewed are four studies that modeled health benefits of using filtration to reduce indoor exposures to particles from outdoors. Prior reviews generally concluded that particle filtration is, at best, a source of small improvements in allergy and asthma health effects; however, many early studies had weak designs. A majority of recent intervention studies employed strong designs and more of these studies report statistically significant improvements in health symptoms or objective health outcomes, particularly for subjects with allergies or asthma. The percentage improvement in health outcomes is typically modest, for example, 7% to 25%. Delivery of filtered air to the breathing zone of sleeping allergic or asthmatic persons may be more consistently effective in improving health than room air filtration. Notable are two studies that report statistically significant improvements, with filtration, in markers that predict future adverse coronary events. From modeling, the largest potential benefits of indoor particle filtration may be reductions in morbidity and mortality from reducing indoor exposures to particles from outdoor air.