Trial Outcomes & Findings for Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors (NCT NCT04103346)
NCT ID: NCT04103346
Last Updated: 2026-01-16
Results Overview
Systolic blood pressure was measured twice a day, in the morning and the evening, from Tuesday through Friday during the first and fourth week of each of the four-week periods in which participants were exposed to one of the interventions. Results reflect the average of systolic readings taken.
COMPLETED
NA
52 participants
10 weeks
2026-01-16
Participant Flow
17 participants withdrew from the trial prior to randomization. Of the 35 participants who were randomized, data from 2 was not included in the analyses, because of external factors that rendered the data from those participants unusable.
Participant milestones
| Measure |
Air Filtration With Hepa Filter, Then With Hepa Filter Removed
air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted, then with the filter removed following washout (sham comparator).
air filtration with air purifier with hepa filter: long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
sham: air purifier running with air filter removed
|
Air Filtration Without Hepa Filter, Then With Hepa Filter
sham comparator used the Holmes HAP8650B-NU-1 air purifier to be operated without the filter, then with the hepa filter installed following washout.
air filtration with air purifier with hepa filter: long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
sham: air purifier running with air filter removed
|
|---|---|---|
|
Phase 1 - 4 Weeks
STARTED
|
21
|
12
|
|
Phase 1 - 4 Weeks
COMPLETED
|
21
|
12
|
|
Phase 1 - 4 Weeks
NOT COMPLETED
|
0
|
0
|
|
Washout - 2 Weeks
STARTED
|
21
|
12
|
|
Washout - 2 Weeks
COMPLETED
|
21
|
12
|
|
Washout - 2 Weeks
NOT COMPLETED
|
0
|
0
|
|
Phase II - 4 Weeks
STARTED
|
21
|
12
|
|
Phase II - 4 Weeks
COMPLETED
|
21
|
12
|
|
Phase II - 4 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
Baseline characteristics by cohort
| Measure |
Air Filtration With Hepa Filter, Then With Hepa Filter Removed
n=21 Participants
air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted, then with the filter removed following washout (sham comparator).
air filtration with air purifier with hepa filter: long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
sham: air purifier running with air filter removed
|
Air Filtration Without Hepa Filter, Then With Hepa Filter
n=12 Participants
sham comparator used the Holmes HAP8650B-NU-1 air purifier to be operated without the filter, then with the hepa filter installed following washout.
air filtration with air purifier with hepa filter: long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
sham: air purifier running with air filter removed
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
History of coronary artery disease
No
|
15 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
23 Participants
n=9 Participants
|
|
Age, Continuous
|
76.2 years
STANDARD_DEVIATION 7.11 • n=9 Participants
|
72.5 years
STANDARD_DEVIATION 8.12 • n=6 Participants
|
74.9 years
STANDARD_DEVIATION 7.59 • n=9 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
11 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
33 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
33 Participants
n=9 Participants
|
|
Body Mass Index (BMI)
|
28.7 kg/m2
STANDARD_DEVIATION 6.21 • n=9 Participants
|
30.2 kg/m2
STANDARD_DEVIATION 8.41 • n=6 Participants
|
29.2 kg/m2
STANDARD_DEVIATION 6.99 • n=9 Participants
|
|
History of coronary artery disease
Yes
|
6 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
History of cerebrovascular disease
No
|
20 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
29 Participants
n=9 Participants
|
|
History of cerebrovascular disease
Yes
|
1 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
|
History of hyperlipidemia
No
|
9 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
|
History of hyperlipidemia
Yes
|
12 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
|
History of hypertension
No
|
6 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
History of hypertension
Yes
|
15 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
24 Participants
n=9 Participants
|
|
History of diabetes
No
|
12 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
|
History of diabetes
Yes
|
9 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=9 Participants
|
|
Blood Pressure Medication
No
|
6 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Blood Pressure Medication
Yes
|
15 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
24 Participants
n=9 Participants
|
|
Statin
No
|
9 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
|
Statin
Yes
|
12 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
|
Diabetes medication
No
|
12 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
|
Diabetes medication
Yes
|
9 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=9 Participants
|
|
Aspirin
No
|
14 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
|
Aspirin
Yes
|
7 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
11 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 10 weeksSystolic blood pressure was measured twice a day, in the morning and the evening, from Tuesday through Friday during the first and fourth week of each of the four-week periods in which participants were exposed to one of the interventions. Results reflect the average of systolic readings taken.
Outcome measures
| Measure |
Air Filtration With Hepa Filter Removed
n=33 Participants
sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.
sham: air purifier running with air filter removed
|
Air Filtration With Hepa Filter
n=33 Participants
air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted.
air filtration with air purifier with hepa filter: long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
|
|---|---|---|
|
Systolic Blood Pressure
|
126.5 mm Hg
Standard Deviation 16.0
|
127.0 mm Hg
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: 10 weeksDiastolic blood pressure was measured twice a day, in the morning and the evening, from Tuesday through Friday during the first and fourth week of each of the four-week periods in which participants were exposed to one of the interventions. Results reflect the average of diastolic readings taken.
Outcome measures
| Measure |
Air Filtration With Hepa Filter Removed
n=33 Participants
sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.
sham: air purifier running with air filter removed
|
Air Filtration With Hepa Filter
n=33 Participants
air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted.
air filtration with air purifier with hepa filter: long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
|
|---|---|---|
|
Diastolic Blood Pressure
|
75.3 mm Hg
Standard Deviation 10.4
|
75.1 mm Hg
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: 10 weeksAtmospheric particulate matter was measured daily in the units of ug/m3 and determined using a portable analyzer (PDR-1500). Results reflect the average amount of atmospheric particulate matter present per day.
Outcome measures
| Measure |
Air Filtration With Hepa Filter Removed
n=33 Participants
sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.
sham: air purifier running with air filter removed
|
Air Filtration With Hepa Filter
n=33 Participants
air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted.
air filtration with air purifier with hepa filter: long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
|
|---|---|---|
|
Atmospheric Particulate Matter (pm2.5) - Indoor
|
8.3 (µg/m3) per day
Standard Deviation 12.8
|
1.3 (µg/m3) per day
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 10 weeksAtmospheric particulate matter was measured daily in units of ug/m3 and determined using a portable analyzer (PDR-1500). Results reflect the average amount of atmospheric particulate matter present per day.
Outcome measures
| Measure |
Air Filtration With Hepa Filter Removed
n=33 Participants
sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.
sham: air purifier running with air filter removed
|
Air Filtration With Hepa Filter
n=33 Participants
air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted.
air filtration with air purifier with hepa filter: long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
|
|---|---|---|
|
Atmospheric Particulate Matter (pm2.5) - Outdoor
|
8.9 (µg/m3) per day
Standard Deviation 2.3
|
10.3 (µg/m3) per day
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 2 daysPM2.5 mass measured from the filters contained in the personal particulate monitors worn for 24-hours by participants performed on the last week of each cross-over limb (twice per participant in total). 24-hour data collection for personal PM2.5 exposure was collected from Thursday morning at 9 am to Friday morning at 9 am during trial week 4 and during trial week 10.
Outcome measures
| Measure |
Air Filtration With Hepa Filter Removed
n=33 Participants
sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.
sham: air purifier running with air filter removed
|
Air Filtration With Hepa Filter
n=33 Participants
air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted.
air filtration with air purifier with hepa filter: long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
|
|---|---|---|
|
24-hr Personal PM2.5 (Filter-gravimetric Mass)
|
12.4 µg/m3 per 24-hour period
Standard Deviation 15.6
|
5.1 µg/m3 per 24-hour period
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected.
Evaluation of the effect of active vs sham filtration on lowering black carbon levels and hourly levels of PM2.5 throughout a 24-hour period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeksPopulation: This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected.
Determined using pulse wave analyses of the augmentation index calculated as the height of the reflected wave as a percentage of the total height of the ascending aortic pressure wave.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeksPopulation: This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected.
To determine the impact of reduced particulate matter on insulin sensitivity, determined by measuring insulin and glucose to calculate the homeostasis model assessment of insulin resistance (HOMA-IR) metric.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeksPopulation: This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected.
Panel of hair, saliva, blood
Outcome measures
Outcome data not reported
Adverse Events
Air Filtration With Hepa Filter
Air Filtration Without Hepa Filter
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