Cardiometabolic Health
Conditions
Brief summary
Exposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity.
Detailed description
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.
Interventions
OTHERair 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.
OTHERsham
air purifier running with air filter removed
Sponsors
University of Michigan
Michigan State University
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
filtration units with or without filters. filters are placed by research assistant from the environmental college and researchers performing the health outcomes are blinded to the condition (sham or active filtration) along with the subject.
Intervention model description
crossover of active filtration in subject's residence with a home filtration unit (Holmes air filtration unit Model HAP8650B-NU-1) versus an inactive sham filtration
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Nonsmoker * ≥60 years old * residing in Carpenter Place Apartments
Exclusion criteria
* Active cigarette smoker * daily secondhand smoke exposure (self-report) * any CV event (myocardial infarction, stroke, heart failure, revascularization) in the past 3 months * unstable CV condition or risk factor (uncontrolled diabetes, class 3-4 angina or heart failure) or any medical condition that would place the participant at risk from participation or jeopardize study integrity (per investigators) * expected overnight travel outside their apartment during the 14-week study period * unable to provide informed consent * lung disease requiring oxygen * renal dialysis * cancer receiving active treatment or chemotherapy * severe uncontrolled high BP ≥160/100 mm Hg or SBP\<115 mm Hg. * CV medication change in the prior month. If participants are on medications for high BP, diabetes, or a CV condition, they will need to have stable therapy during the prior month with no planned changes during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure | 10 weeks | 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. |
| Atmospheric Particulate Matter (pm2.5) - Indoor | 10 weeks | 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. |
| Atmospheric Particulate Matter (pm2.5) - Outdoor | 10 weeks | 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. |
| 24-hr Personal PM2.5 (Filter-gravimetric Mass) | 2 days | 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. |
| Black Carbon, Hourly Personal PM2.5 Levels | 10 weeks | 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. |
| Aortic Hemodynamics | 10 weeks | 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. |
| Insulin Sensitivity | 10 weeks | 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. |
| Adrenal Steroid Panel | 10 weeks | Panel of hair, saliva, blood |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Brook, MD
Wayne State University
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| 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 | 12 |
| Total | 33 |
Baseline characteristics
| Characteristic | Air Filtration Without Hepa Filter, Then With Hepa Filter | Total | Air Filtration With Hepa Filter, Then With Hepa Filter Removed |
|---|---|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 8.12 | 74.9 years STANDARD_DEVIATION 7.59 | 76.2 years STANDARD_DEVIATION 7.11 |
| Aspirin No | 8 Participants | 22 Participants | 14 Participants |
| Aspirin Yes | 4 Participants | 11 Participants | 7 Participants |
| Blood Pressure Medication No | 3 Participants | 9 Participants | 6 Participants |
| Blood Pressure Medication Yes | 9 Participants | 24 Participants | 15 Participants |
| Body Mass Index (BMI) | 30.2 kg/m2 STANDARD_DEVIATION 8.41 | 29.2 kg/m2 STANDARD_DEVIATION 6.99 | 28.7 kg/m2 STANDARD_DEVIATION 6.21 |
| Diabetes medication No | 10 Participants | 22 Participants | 12 Participants |
| Diabetes medication Yes | 2 Participants | 11 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 33 Participants | 21 Participants |
| History of cerebrovascular disease No | 9 Participants | 29 Participants | 20 Participants |
| History of cerebrovascular disease Yes | 3 Participants | 4 Participants | 1 Participants |
| History of coronary artery disease No | 8 Participants | 23 Participants | 15 Participants |
| History of coronary artery disease Yes | 4 Participants | 10 Participants | 6 Participants |
| History of diabetes No | 10 Participants | 22 Participants | 12 Participants |
| History of diabetes Yes | 2 Participants | 11 Participants | 9 Participants |
| History of hyperlipidemia No | 9 Participants | 18 Participants | 9 Participants |
| History of hyperlipidemia Yes | 3 Participants | 15 Participants | 12 Participants |
| History of hypertension No | 3 Participants | 9 Participants | 6 Participants |
| History of hypertension Yes | 9 Participants | 24 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 22 Participants | 14 Participants |
| Region of Enrollment United States | 12 Participants | 33 Participants | 21 Participants |
| Sex: Female, Male Female | 7 Participants | 22 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
| Statin No | 9 Participants | 18 Participants | 9 Participants |
| Statin Yes | 3 Participants | 15 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Air Filtration With Hepa Filter | Systolic Blood Pressure | 127.0 mm Hg | Standard Deviation 16.2 |
| Air Filtration With Hepa Filter Removed | Systolic Blood Pressure | 126.5 mm Hg | Standard Deviation 16 |
p-value: 0.588Mixed Effects Model
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Air Filtration With Hepa Filter | 24-hr Personal PM2.5 (Filter-gravimetric Mass) | 5.1 µg/m3 per 24-hour period | Standard Deviation 4.6 |
| Air Filtration With Hepa Filter Removed | 24-hr Personal PM2.5 (Filter-gravimetric Mass) | 12.4 µg/m3 per 24-hour period | Standard Deviation 15.6 |
p-value: <0.001Mixed Effects Model
Secondary
Adrenal Steroid Panel
Panel of hair, saliva, blood
Time frame: 10 weeks
Population: This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected.
Secondary
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
Population: This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Air Filtration With Hepa Filter | Atmospheric Particulate Matter (pm2.5) - Indoor | 1.3 (µg/m3) per day | Standard Deviation 1.5 |
| Air Filtration With Hepa Filter Removed | Atmospheric Particulate Matter (pm2.5) - Indoor | 8.3 (µg/m3) per day | Standard Deviation 12.8 |
p-value: <0.001Mixed Effects Model
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Air Filtration With Hepa Filter | Atmospheric Particulate Matter (pm2.5) - Outdoor | 10.3 (µg/m3) per day | Standard Deviation 5.8 |
| Air Filtration With Hepa Filter Removed | Atmospheric Particulate Matter (pm2.5) - Outdoor | 8.9 (µg/m3) per day | Standard Deviation 2.3 |
p-value: 0.0764Mixed Effects Model
Secondary
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
Population: This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Air Filtration With Hepa Filter | Diastolic Blood Pressure | 75.1 mm Hg | Standard Deviation 10.6 |
| Air Filtration With Hepa Filter Removed | Diastolic Blood Pressure | 75.3 mm Hg | Standard Deviation 10.4 |
p-value: 0.748Mixed Effects Model
Secondary
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
Population: This outcome was not performed because of COVID-19 restrictions in place during the trial, and no data for this outcome will be collected.