## Protocol Section
### Identification Module
**NCT ID:** NCT05874479

**Acronym:** AirPressureNYC

**Brief Title:** Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents

**Official Title:** Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents

#### Organization Study ID Info
**ID:** 23-00517
#### Organization
**Class:** OTHER
**Full Name:** NYU Langone Health
### Status Module
#### Completion Date
**Date:** 2028-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-27

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-20

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2023-05-25
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-12
**Study First Submit QC Date:** 2023-05-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Heart, Lung, and Blood Institute (NHLBI)

#### Lead Sponsor

**Class:** OTHER

**Name:** NYU Langone Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Blood Pressure

**Keywords:**

- self-measured morning home systolic blood pressure (AM H-SBP)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 440

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Active PAC

**Label:** Active Portable Air Cleaner (PAC)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: Sham PAC

**Label:** Sham PAC

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Active Portable Air Cleaner (PAC)

**Description:** The active PAC will contain HEPA filters inside the device.

**Name:** Active PAC

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Sham PAC

**Description:** The sham PAC will contain no HEPA filters inside the device.

**Name:** Sham PAC

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Participants measure HBP every day between 6-9 am.

**Measure:** Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 30 Days

**Time Frame:** Up to Day 30

#### Secondary Outcomes

**Description:** Participants measure HBP every day between 6-9 am.

**Measure:** Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 90 Days

**Time Frame:** Up to Day 90

**Description:** Participants measure HBP every day between 6-9 am.

**Measure:** Average Self-Measured Morning Home Systolic Blood Pressure (AM H-SBP) over 180 Days

**Time Frame:** Up to Day 180

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** AirPressureNYC@nyulangone.org

**Name:** Jonathan Newman

**Phone:** (212) 263-9393

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** NYU Langone Health

**State:** New York

**Status:** RECRUITING

**Zip:** 10016

#### Overall Officials

**Official 1:**

**Affiliation:** NYU Langone Health

**Name:** Jonathan Newman

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** 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.

**Description:** 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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M27583

- Name: Systolic Murmurs

- Relevance: LOW

- As Found: Unknown

- ID: M10072

- Name: Hypotension

- Relevance: HIGH

- As Found: Lower Blood Pressure

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007022

- Term: Hypotension

### Misc Info Module

- Version Holder: 2024-05-24
