Portable Air Cleaners for High Blood Pressure

(AirPressureNYC Trial)

Overseen By Elle Anastasiou Pesante

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Arrhythmias, Severe hypertension, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 30 days

440 Participants Needed

Trial Summary

What is the purpose of this trial?

Fine particulate matter \<2.5 µm (PM2.5) air pollution is the fifth leading risk factor for global mortality, with the largest portion of deaths due to cardiovascular disease (CVD). While several mechanisms are responsible, PM2.5-induced elevations in blood pressure (BP) may be relevant. Indoor portable air cleaners (PACs) are a novel approach to reduce exposure to PM2.5 and potentially lower blood pressure. The current study is being conducted to provide evidence that PACs reduce PM2.5 exposure and lower systolic blood pressure (SBP) in key patient populations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you plan to change your drug regimen during the first 30 days of the trial.

How does the treatment 'Portable Air Cleaners' for high blood pressure differ from other treatments?

Portable air cleaners are unique because they focus on improving indoor air quality to help manage high blood pressure, unlike traditional treatments that typically involve medication or lifestyle changes. This approach is novel as it targets environmental factors that may contribute to high blood pressure, rather than directly altering the body's physiological processes. ^{1 2 3 4 5}

Research Team

Jonathan Newman

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for non-smoking adults with hypertension living in NYC public housing who don't have severe high blood pressure, major arrhythmias, cardiovascular disease, lung disease requiring oxygen, end-stage renal disease or cancer under treatment. They shouldn't plan to travel out of NYC for long periods or change their medication soon.

Inclusion Criteria

You do not smoke and live with people who do not smoke.

This criterion includes adults who have high blood pressure and live in public housing in New York City.

Exclusion Criteria

I haven't changed my blood pressure medication in the last 2 weeks and don't plan to change it in the next 30 days.

I need oxygen for my lung condition.

I have a history of serious heart rhythm problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initiation of PAC devices and monitoring setup

1 day

1 visit (in-person)

Treatment

Participants use PACs in their bedrooms for 30 days to reduce PM2.5 exposure

30 days

Daily self-monitoring

Follow-up

Participants are monitored for changes in blood pressure over an extended period

180 days

Self-monitoring and periodic check-ins

Treatment Details

Interventions

• Active PAC
• Sham PAC

Trial Overview The study tests if portable air cleaners (PACs) can reduce indoor fine particulate matter and lower systolic blood pressure. Participants will be randomly assigned to use either an active PAC that filters the air or a sham PAC that does not work but looks identical.

Participant Groups

Group I: Active Portable Air Cleaner (PAC) Experimental Treatment 1 Intervention

Using a double-blind randomized process, active PACs (with HEPA filters inside) will be assembled and placed in the bedroom of study participants. Initiation of the PAC devices will occur at baseline on Day 0. After completion of enrollment, consent and the placement of PACs, electricity monitors, and PurpleAir monitoring, the PAC will be turned on. Participants will be instructed to keep the PACs on in bedrooms during the study duration, closing bedroom doors at night and during the day, when possible. The PAC will run for 24 hours on Day 0 of the study protocol before the 30-day treatment period begins. A kilowatt meter will be installed with the PAC to monitor electricity usage as a measure of adherence.

Group II: Sham PAC Placebo Group 1 Intervention

Using a double-blind randomized process, sham PACs (with no filters inside) will be assembled and placed in the bedroom of study participants. Initiation of the PAC devices will occur at baseline on Day 0. After completion of enrollment, consent and the placement of PACs, electricity monitors, and PurpleAir monitoring, the PAC will be turned on. Participants will be instructed to keep PACs on in bedrooms during the study duration, closing bedroom doors at night and during the day, when possible. The PAC will run for 24 hours on Day 0 of the study protocol before the 30-day treatment period begins. A kilowatt meter will be installed with the PAC to monitor electricity usage as a measure of adherence.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

A 4-week hypertension management program conducted in a faith-based setting showed significant improvements in self-care behaviors among African American participants.

Participants also experienced lowered blood pressure readings, indicating that faith-based organizations can effectively promote health and manage hypertension in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting a Faith-Based Hypertension Self-Care Program in a Church Setting. Alen, J., Forehand, J., Miller, B.[2023]

Self-measurement of blood pressure at home is possible with various devices, but accuracy can vary significantly, especially among automated models, which may not always provide reliable readings.

To ensure effective self-monitoring, healthcare professionals must recommend accurate devices and provide guidance on their proper use, as many consumers require assistance with calibration and understanding device instructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-measurement of blood pressure: assessment of equipment. Canadian Coalition for High Blood Pressure Prevention and Control. McKay, DW., Campbell, NR., Chockalingam, A., et al.[2008]

Approximately 60 million Americans have high blood pressure, with 35 million requiring ongoing treatment, highlighting the significant public health challenge posed by untreated hypertension, which is a major contributor to stroke and heart disease.

The National High Blood Pressure Education Program has successfully increased awareness and control of hypertension, leading to a decline in related deaths, particularly from stroke, but there is still a need for improved adherence to treatment regimens and better access to care for minority groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive health services: High blood pressure control. [2008]

A qualitative study involving 35 healthcare providers from Peru and Cameroon found that home blood pressure management, including self-monitoring and medication self-titration, is generally viewed as feasible and acceptable by providers in both countries.

Providers expressed concerns about patient safety during self-titration, the need for supportive resources and policies, and the importance of ensuring patient adherence through education and integration into clinical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare provider's perspectives on home blood pressure management in Peru and Cameroon: Findings from the BPMONITOR study. Al-Rousan, T., Awad, M., Amalia Pesantes, M., et al.[2023]

The Mobile You Blood Pressure Program, an interactive voice response (IVR) system linked to electronic health records, was implemented to improve blood pressure monitoring among hypertensive patients, enrolling 71 patients across 14 clinics.

The program faced challenges, particularly with patient enrollment, as access to validated home blood pressure monitors was identified as a significant barrier by pharmacists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and barriers to uptake of interactive voice response technology aimed to improve blood pressure control at a large academic medical center. Ashjian, EJ., Yoo, A., Piette, JD., et al.[2020]

References

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

Piloting a Faith-Based Hypertension Self-Care Program in a Church Setting. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Self-measurement of blood pressure: assessment of equipment. Canadian Coalition for High Blood Pressure Prevention and Control. [2008]

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

Preventive health services: High blood pressure control. [2008]

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

Healthcare provider's perspectives on home blood pressure management in Peru and Cameroon: Findings from the BPMONITOR study. [2023]

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

Implementation and barriers to uptake of interactive voice response technology aimed to improve blood pressure control at a large academic medical center. [2020]