Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05874479
Other study ID # 23-00517
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 20, 2023
Est. completion date March 2028

Study information

Verified date December 2023
Source NYU Langone Health
Contact Jonathan Newman
Phone (212) 263-9393
Email AirPressureNYC@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 440
Est. completion date March 2028
Est. primary completion date September 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - self-reported nonsmokers living in a nonsmoking household. - adults living with hypertension (HTN) from NYC public housing. Exclusion Criteria: - History of major known arrhythmias (e.g. atrial flutter or fibrillation, ventricular tachycardia). - Screening systolic BP =160 mm Hg or diastolic BP =100 mm Hg (i.e. severe hypertension by the 2017 ACC/AHA BP guideline). - A change in drug regimen in the prior 2 weeks or a planned change in drug regimen during the first 30 days for those taking antihypertensive medication. - Current smoking or living with an active smoker who smokes indoors - Planned travel out of NYC for =2 weeks in next 6 months - Incarcerated - Pregnant - Unable/unwilling to consent - Established cardiovascular disease - End-stage renal disease (chronic kidney disease stage IV or on dialysis) - Barrier to technology use (e.g., visual or hearing impairment) - Lung disease requiring oxygen - Cancer receiving treatment

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Active PAC
The active PAC will contain HEPA filters inside the device.
Sham PAC
The sham PAC will contain no HEPA filters inside the device.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days Participants measure HBP every day between 6-9 am. Up to Day 30
Secondary Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days Participants measure HBP every day between 6-9 am. Up to Day 90
Secondary Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days Participants measure HBP every day between 6-9 am. Up to Day 180
See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Recruiting NCT05997303 - Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT03918486 - Caretaker vs. Routine Blood Pressure Sphygmomanometer
Completed NCT03410342 - The Effects of Types of Fruits and Vegetables on Vascular Function N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT04087070 - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed NCT03294928 - Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers N/A
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03997461 - Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device N/A
Completed NCT03290716 - Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China N/A
Recruiting NCT05196048 - Blood Pressure Sensor of Watch-type Device With ECG Technology
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Completed NCT02924454 - Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol. Phase 4
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Active, not recruiting NCT02670967 - Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials N/A
Completed NCT02271633 - Nitrate Supplementation; Source Phase 4
Completed NCT02239744 - Intervention Study on the Health Impact of Air Filters in Chinese Adults N/A
Terminated NCT01633814 - Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women N/A
Completed NCT01030458 - Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial Phase 4