Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Portable Air Cleaner (PAC) | Experimental | 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. |
|
| Sham PAC | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active PAC | Device | The active PAC will contain HEPA filters inside the device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Newman | Contact | (212) 263-9393 | AirPressureNYC@nyulangone.org | |
| Elle Anastasiou Pesante | Contact | (646) 501-3613 | elle.anastasiou@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Newman | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Jonathan.newman@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Jonathan.newman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham PAC | Device | The sham PAC will contain no HEPA filters inside the device. |
|
Participants measure HBP every day between 6-9 am.
| Up to Day 180 |