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Behavioural Intervention
Portable Air Cleaners for High Blood Pressure (AirPressureNYC Trial)
N/A
Recruiting
Led By Jonathan Newman
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Lung disease requiring oxygen
History of major known arrhythmias (e.g. atrial flutter or fibrillation, ventricular tachycardia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 180
Summary
This trial will assess if using portable air cleaners can reduce PM2.5 air pollution and lower blood pressure, which is a leading global cause of death.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves using portable air cleaners rather than medications, there are no direct side effects from drugs. However, participants may experience placebo effects or discomfort due to changes in indoor air quality.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need oxygen for my lung condition.
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I have a history of serious heart rhythm problems.
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I have a diagnosed heart condition.
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I have severe kidney disease or am on dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days
Secondary study objectives
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days
Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Portable Air Cleaner (PAC)Experimental Treatment1 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 PACPlacebo Group1 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.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,148 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,791,891 Total Patients Enrolled
Jonathan NewmanPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
142 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have a diagnosed heart condition.Currently in jail.You do not smoke and live with people who do not smoke.I am currently receiving treatment for cancer.This criterion includes adults who have high blood pressure and live in public housing in New York City.Your blood pressure is very high, with a systolic reading of 160 or higher, or a diastolic reading of 100 or higher.You are currently smoking or living with someone who smokes indoors.I have severe kidney disease or am on dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Sham PAC
- Group 2: Active Portable Air Cleaner (PAC)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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