Exposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity.
This is a randomized double-blind placebo-controlled (sham filtration) crossover trial comparing the effectiveness bedroom-only portable indoor air filtration units \[AFUs\] to reduce personal PM2.5 exposures and improve cardiometabolic health. The health benefits (primary outcome: resting BP) will be evaluated over acute (4-day) and long-term (4-week) periods in 50 nonsmoking elderly adults living in a senior facility impacted by near-roadway pollutants. Because of COVID-19 restrictions that occurred during the trial, certain outcome measures were removed from the protocol, as they could not be performed: 24-hr Blood Pressure, Heart Rate Variability (HRV), BpTRU BP measurements, and WatchPAT. Other outcome measures were not removed from the protocol, but data could not be collected for them because of COVID restrictions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
52
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.
air purifier running with air filter removed
University of Michigan
Ann Arbor, Michigan, United States
Systolic Blood Pressure
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.
Time frame: 10 weeks
Diastolic Blood Pressure
Diastolic 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.
Time frame: 10 weeks
Atmospheric Particulate Matter (pm2.5) - Indoor
Atmospheric 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.
Time frame: 10 weeks
Atmospheric Particulate Matter (pm2.5) - Outdoor
Atmospheric 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.
Time frame: 10 weeks
24-hr Personal PM2.5 (Filter-gravimetric Mass)
PM2.5 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.
Time frame: 2 days
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Black Carbon, Hourly Personal PM2.5 Levels
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.
Time frame: 10 weeks
Aortic Hemodynamics
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.
Time frame: 10 weeks
Insulin Sensitivity
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.
Time frame: 10 weeks
Adrenal Steroid Panel
Panel of hair, saliva, blood
Time frame: 10 weeks