HEPA Filters for Cardiometabolic Health

Overseen By Junfeng Zhang, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Diabetes, Alzheimer's, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

52 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

How 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. ^{4 6 7 8 9}

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.

Research Team

Zhanghua Chen, PhD

Principal Investigator

University of Southern California

Junfeng Zhang, PhD

Principal Investigator

Duke University

Eligibility 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

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

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

Treatment Details

Interventions

• HEPA filter
• Sham filter

Trial Overview 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.

Participant Groups

Group I: HEPA first and sham Experimental Treatment 2 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 HEPA Placebo Group 2 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

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Findings from Research

In a pilot study involving 20 elderly cardiac patients, the use of active portable air cleaners (PACs) significantly reduced personal PM2.5 exposure by 43.8% compared to sham devices, indicating their effectiveness in improving air quality for at-risk individuals.

The findings suggest that using inexpensive in-home PACs could lead to substantial long-term health benefits for cardiac patients by potentially reducing the risk of cardiovascular events, even in areas with generally good air quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Fine Particulate Matter Air Pollution Exposures Using In-Home Portable Air Cleaners: PILOT RESULTS OF THE CARDIAC REHABILITATION AIR FILTER TRIAL (CRAFT). Bard, RL., Rubenfire, M., Fink, S., et al.[2021]

A study of over 155,000 ischemic stroke admissions among Medicare recipients found that short-term increases in PM10 particulate matter were associated with a 1.03% increase in admissions on the same day, indicating a potential risk factor for ischemic stroke.

In contrast, no significant association was found between particulate matter and hemorrhagic stroke admissions, suggesting that air pollution may specifically impact the risk of ischemic strokes rather than hemorrhagic ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Air pollution and hospital admissions for ischemic and hemorrhagic stroke among medicare beneficiaries. Wellenius, GA., Schwartz, J., Mittleman, MA.[2016]

Fine particulate air pollution (PM2.5) is recognized as a significant risk factor for heart and lung diseases, highlighting the urgent need for effective interventions.

Personal-level strategies to reduce PM2.5 exposure have shown potential health benefits, and further randomized clinical trials are necessary to assess their feasibility and efficacy, especially in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Impact of Particulate Air Pollution in High-Risk Populations: JACC State-of-the-Art Review. Newman, JD., Bhatt, DL., Rajagopalan, S., et al.[2023]

In a study involving six healthy volunteers, the use of portable HEPA filters during exercise testing significantly reduced aerosol concentrations by up to 96% across all particle sizes, indicating their effectiveness in minimizing airborne particles during physical activity.

The portable HEPA filter also decreased aerosol clearance time in a clinical exercise testing laboratory by 47% compared to using HVAC alone, suggesting it could enhance safety by reducing the risk of COVID-19 transmission in such settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitigation of Aerosols Generated During Exercise Testing With a Portable High-Efficiency Particulate Air Filter With Fume Hood. Garzona-Navas, A., Sajgalik, P., Csécs, I., et al.[2021]

Exposure to diesel engine exhaust significantly reduced exercise capacity in heart failure patients, as shown by decreased VO2, six-minute walking test distance, and O2Pulse during exercise.

Using a respiratory filter during exposure to diesel exhaust improved VO2 and O2Pulse in heart failure patients, suggesting that filtration can mitigate the harmful effects of air pollution on exercise performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Vieira, JL., Guimaraes, GV., de Andre, PA., et al.[2022]

The RAPIDS study demonstrated that high-efficiency particulate arrestance (HEPA) filters significantly reduce indoor PM2.5 concentrations by 60% and personal PM2.5 exposures by 53% among senior citizens in Detroit, indicating their effectiveness in improving air quality and potentially cardiovascular health.

Low-efficiency (HEPA-type) filters also provided benefits, reducing indoor PM2.5 concentrations by 52% and personal exposures by 31%, suggesting that even less efficient filters can contribute to lowering harmful air pollution levels indoors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of personal PM2.5 exposure via indoor air filtration systems in Detroit: an intervention study. Maestas, MM., Brook, RD., Ziemba, RA., et al.[2021]

A study involving 30 healthy subjects showed that a vehicle cabin air filter with active charcoal significantly reduced diesel exhaust (DE) particulate matter and harmful gases, leading to fewer reported symptoms compared to unfiltered air.

The active charcoal filter reduced nitrogen dioxide (NO2) and hydrocarbon concentrations by 75% and 50%, respectively, while also demonstrating less inflammatory effects on lung cells, indicating its potential to protect against the harmful effects of diesel exhaust.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the capacity of vehicle cabin air inlet filters to reduce diesel exhaust-induced symptoms in human volunteers. Muala, A., Sehlstedt, M., Bion, A., et al.[2022]

The new inertial impaction filters can remove up to 97.77% of PM2.5 and 99.47% of PM10 particles at an airflow velocity of 8.0 m/s, demonstrating high efficiency in particulate matter removal.

These filters have a significantly low pressure drop of 5-10 Pa and high quality factor values, making them more effective and less obstructive compared to traditional air filters, which could lead to better public health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-performance inertial impaction filters for particulate matter removal. Zhang, X., Zhang, W., Yi, M., et al.[2023]

Recent studies show that particle filtration in homes and commercial buildings can lead to statistically significant improvements in health symptoms, particularly for individuals with allergies or asthma, with percentage improvements typically ranging from 7% to 25%.

Filtered air delivered directly to the breathing zone of allergic or asthmatic individuals is more effective than general room air filtration, and modeling suggests that reducing indoor exposure to outdoor particles could significantly lower morbidity and mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits of particle filtration. Fisk, WJ.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reduced Fine Particulate Matter Air Pollution Exposures Using In-Home Portable Air Cleaners: PILOT RESULTS OF THE CARDIAC REHABILITATION AIR FILTER TRIAL (CRAFT). [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Air pollution and hospital admissions for ischemic and hemorrhagic stroke among medicare beneficiaries. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Impact of Particulate Air Pollution in High-Risk Populations: JACC State-of-the-Art Review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Mitigation of Aerosols Generated During Exercise Testing With a Portable High-Efficiency Particulate Air Filter With Fume Hood. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

Reduction of personal PM2.5 exposure via indoor air filtration systems in Detroit: an intervention study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Assessment of the capacity of vehicle cabin air inlet filters to reduce diesel exhaust-induced symptoms in human volunteers. [2022]

8. England pubmed.ncbi.nlm.nih.gov

High-performance inertial impaction filters for particulate matter removal. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Health benefits of particle filtration. [2022]