Trial Outcomes & Findings for Cleaner Air for Better Cardiac Biomarkers (NCT NCT05379400)
NCT ID: NCT05379400
Last Updated: 2024-12-06
Results Overview
Circulating concentrations of TNFα will be measured using the Olink Explore 384 Cardiometabolic panel for this a priori specified analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Baseline, Week 4
Results posted on
2024-12-06
Participant Flow
48 participants were enrolled, n=2 did not start the study.
Participant milestones
| Measure |
Portable Air Cleaner (PAC) Group
This study will utilize a portable air cleaner as an intervention for the potential reduction of air pollution-associated inflammation. This commercially available device has no significant risks. The researchers plan to use a commercially available PAC with a "true HEPA" filter for the true arm.
Portable 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.
|
Sham Portable Air Cleaner (PAC) Group
For the sham arm, the same model will be used with HEPA filter removed, and has identical appearance and sound. The researchers will use a PAC designed to filter air in rooms up to approximately 350 ft2, with minimal noise on the lowest setting.
Sham 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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Portable Air Cleaner (PAC) Group
This study will utilize a portable air cleaner as an intervention for the potential reduction of air pollution-associated inflammation. This commercially available device has no significant risks. The researchers plan to use a commercially available PAC with a "true HEPA" filter for the true arm.
Portable 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.
|
Sham Portable Air Cleaner (PAC) Group
For the sham arm, the same model will be used with HEPA filter removed, and has identical appearance and sound. The researchers will use a PAC designed to filter air in rooms up to approximately 350 ft2, with minimal noise on the lowest setting.
Sham 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Cleaner Air for Better Cardiac Biomarkers
Baseline characteristics by cohort
| Measure |
Portable Air Cleaner (PAC) Group
n=22 Participants
This study will utilize a portable air cleaner as an intervention for the potential reduction of air pollution-associated inflammation. This commercially available device has no significant risks. The researchers plan to use a commercially available PAC with a "true HEPA" filter for the true arm.
Portable 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.
|
Sham Portable Air Cleaner (PAC) Group
n=22 Participants
For the sham arm, the same model will be used with HEPA filter removed, and has identical appearance and sound. The researchers will use a PAC designed to filter air in rooms up to approximately 350 ft2, with minimal noise on the lowest setting.
Sham 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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 11 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Circulating concentrations of TNFα will be measured using the Olink Explore 384 Cardiometabolic panel for this a priori specified analysis.
Outcome measures
| Measure |
Portable Air Cleaner (PAC) Group
n=22 Participants
This study will utilize a portable air cleaner as an intervention for the potential reduction of air pollution-associated inflammation. This commercially available device has no significant risks. The researchers plan to use a commercially available PAC with a "true HEPA" filter for the true arm.
Portable 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.
|
Sham Portable Air Cleaner (PAC) Group
n=22 Participants
For the sham arm, the same model will be used with HEPA filter removed, and has identical appearance and sound. The researchers will use a PAC designed to filter air in rooms up to approximately 350 ft2, with minimal noise on the lowest setting.
Sham 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.
|
|---|---|---|
|
Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα)
|
-1.03 percent change
Standard Deviation 8.35
|
2 percent change
Standard Deviation 3.69
|
SECONDARY outcome
Timeframe: Baseline, Week 4Commercially available Particulate Matter (PM) monitors will record indoor PM2.5 concentrations using dual (backup) sensors, which store measurements on internal SD cards
Outcome measures
| Measure |
Portable Air Cleaner (PAC) Group
n=22 Participants
This study will utilize a portable air cleaner as an intervention for the potential reduction of air pollution-associated inflammation. This commercially available device has no significant risks. The researchers plan to use a commercially available PAC with a "true HEPA" filter for the true arm.
Portable 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.
|
Sham Portable Air Cleaner (PAC) Group
n=22 Participants
For the sham arm, the same model will be used with HEPA filter removed, and has identical appearance and sound. The researchers will use a PAC designed to filter air in rooms up to approximately 350 ft2, with minimal noise on the lowest setting.
Sham 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.
|
|---|---|---|
|
Change in Indoor Particulate Matter < 2.5 um in Diameter (PM2.5) Concentration
|
2.698 micrograms per cubic meter air (μ/m3)
Standard Deviation 2.483
|
11.751 micrograms per cubic meter air (μ/m3)
Standard Deviation 20.93
|
Adverse Events
Portable Air Cleaner (PAC) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Portable Air Cleaner (PAC) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place