Clinical Trials Directory

Trials / Completed

CompletedNCT05379400

Cleaner Air for Better Cardiac Biomarkers

Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure Via Home Air Filtration

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
NYU Langone Health · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

This pilot project is a randomized, double-blind, sham-controlled trial investigating whether in-home air pollution reductions using portable air cleaners (PACs) can decrease circulating concentrations of biomarkers of inflammation. Using both a targeted approach to study the established biomarker TNFa and an exploratory approach with a commercially available proteomic panel, the researchers will measure concentrations of biomarkers before and after four weeks of home PAC use in a cohort of 74 adults with hypertension recruited from NYU outpatient clinical settings. Participants will also track home blood pressure measurements for additional exploratory analysis of potential mediation of PAC-associated decreases in blood pressure by biomarker concentration changes.

Detailed description

In Aim 1, the researchers will evaluate associations with PAC use with a priori specified biomarker of inflammation, tumor necrosis factor alpha (TNFα). The researchers will determine if 4 weeks of home air filtration with PACs compared to sham is associated with significant reductions in TNFα concentrations when measured before and after intervention. Blood samples will be collected from 74 study participants before and after 4 weeks of PAC use (true and sham) for biomarker concentration measurement. In Aim 2, the researchers will determine if reductions in fine particulate matter (\<2.5 μm in diameter, PM2.5) as a continuous variable are associated with significant reductions TNFα concentrations over a four-week period.

Conditions

Interventions

TypeNameDescription
OTHERPortable air cleaner (PAC)Commercially available Portable air cleaners (PAC) contain carbon filters that reduce volatile organic carbons and can reduce odors. Because of this, the researchers will remove the carbon filters from all air purifiers to preserve blinding. This will be done by unblinded research staff and devices will be labelled with an ID number to preserve blinding of the rest of the research team.
OTHERSham Portable air cleaner (PAC)Sham Portable air cleaner (PAC) are commercially available portable air cleaners with the carbon filters and the HEPA filters removed. This will be done by unblinded research staff and devices will be labelled with an ID number to preserve blinding of the rest of the research team.

Timeline

Start date
2022-08-11
Primary completion
2023-08-24
Completion
2023-08-24
First posted
2022-05-18
Last updated
2024-12-06
Results posted
2024-12-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05379400. Inclusion in this directory is not an endorsement.