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Reducing Traffic Pollution Exposure Improves Blood Pressure

Near Highway Pollution: From Research to Action

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04029129
Enrollment
77
Registered
2019-07-23
Start date
2018-03-01
Completion date
2018-06-15
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Air Pollution

Keywords

Traffic-related air pollution, Air filtration, Blood pressure, Controlled exposure

Brief summary

This randomized trial assessed the effect of modifying building envelop and level of air filtration on blood pressure over two hour exposure sessions.

Detailed description

Living close to major roadways is associated with elevated blood pressure (BP) amongst other adverse health effects. There is growing evidence that ultrafine particles (UFP, \<100 nm in diameter), which are elevated near major roads and highways, contribute to such risks. We assessed the efficacy of high efficiency particulate arrestance (HEPA) filtration and building envelope adjustment at reducing exposure to and health effects of air pollution next to major highways. We used a randomized three-period crossover trial design to assign 77 participants (aged 40-75 and without diagnosis of hypertension) to three two-hour exposure sessions. Sessions were conducted in one of two rooms immediately adjacent to highways. High, medium and low exposures were attained by varying the degree of air exchange and amount of HEPA filtration in the room. During high exposure sessions, the room was ventilated with outdoor air and no filtration was used. During low exposure sessions, leakage of outdoor air into the room was minimized and HEPA filtration was maximized. During medium exposure sessions, a moderate amount of HEPA filtration was used (less than half of that used in low sessions). Indoor particle number and black carbon (BC) concentrations (i.e., markers of traffic-related air pollution) were monitored continuously. During each session participants sat quietly and wore noise-cancelling headphones, while their BP was monitored every ten minutes using an ambulatory BP monitor. We monitored pulse and oxygen saturation continuously.

Interventions

OTHERAir filtration and building envelop modifications

Air filters and closing and sealing of windows and doors was used to reduce infiltration of air pollution from outdoors in rooms next to major highways at rush hour.

Sponsors

National Institute of Environmental Health Sciences (NIEHS)
CollaboratorNIH
UConn Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Participants were not told the high, medium and low exposure context, however, some aspects of the sessions might have been apparent to them since filters were running during high, but not low exposure sessions.

Intervention model description

Randomized cross over trial

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* The inclusion criterion was age 40-75 years. * There was a preference for people who were otherwise healthy, but overweight or obese.

Exclusion criteria

* A history of a major cardiovascular outcome (including myocardial ischemia (MI), stroke, angina) * Other serious health problems (current asthma or COPD) * Taking anti-hypertensive medications * Smoking or living with a smoker * Cognitive impairment * Working at a job with high combustion exposure (taxi/truck driver, restaurant cook) * High combustion exposure in the preceding 24 hours (driving on the highway, cooking in a restaurant, driving a truck) * Not speaking English or Chinese.

Design outcomes

Primary

MeasureTime frameDescription
Systolic Blood Pressure (SBP)Over 2 hour exposure period, we measured SBP after 20 minutes with the objective to assess change in SBP in a time series of measurements over that time period.Systolic blood pressure measured with ambulatory blood pressure monitors in mmHg.

Secondary

MeasureTime frameDescription
Diastolic Blood Pressure (DBP)Over a 2 hour exposure period with the objective to assess change in DBP measured after 10 minutes in a time series of measurements over that time period.The unit of measurement, mmHg for the diastolic blood pressure.

Countries

United States

Participant flow

Pre-assignment details

Using a 3-period crossover design, 77 participants were randomized to attend. Three 2-hour-long exposure sessions separated by 1-week washout periods. None was excluded.

Participants by arm

ArmCount
High Exposure (First Session), Low, Medium Exposure
Ambient air was allowed freely into the room. Participants first received a 2-hour-long High exposure session. After a washout period of 1 week, they then received a 2-hour-long Low exposure session. After a washout period of 1 week, they then received a 2-hour-long Medium exposure session. All sessions occurred on the same day of the week.
30
Medium Exposure(First Session), High, Low Exposure
Limited air filtration was used to partially reduce levels of pollution in the room relative to outside. Air filtration and building envelop modifications: Air filters and closing and sealing of windows and doors was used to reduce infiltration of air pollution from outdoors in rooms next to major highways at rush hour. Participants first received a 2-hour-long Medium exposure session. After a washout period of 1 week, they then received a 2-hour-long High exposure session. After a washout period of 1 week, they then received a 2-hour-long Low exposure session. All sessions occurred on the same day of the week.
28
Low Exposure (First Session), Medium, High Exposure
Doors and windows were closed and sealed and full filtration was used to maximally reduce pollution in the room. Air filtration and building envelop modifications: Air filters and closing and sealing of windows and doors was used to reduce infiltration of air pollution from outdoors in rooms next to major highways at rush hour. Participants first received a 2-hour-long Low exposure session. After a washout period of 1 week, they then received a 2-hour-long Medium exposure session. After a washout period of 1 week, they then received a 2-hour-long High exposure session. All sessions occurred on the same day of the week.
19
Total77

Baseline characteristics

CharacteristicHigh Exposure (First Session), Low, Medium ExposureTotalLow Exposure (First Session), Medium, High ExposureMedium Exposure(First Session), High, Low Exposure
Age, Continuous59.7 years
STANDARD_DEVIATION 10.5
59.7 years
STANDARD_DEVIATION 10.5
59.7 years
STANDARD_DEVIATION 10.5
63.3 years
STANDARD_DEVIATION 9.6
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants3 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants74 Participants19 Participants26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
23 Participants59 Participants15 Participants21 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
6 Participants15 Participants3 Participants6 Participants
Region of Enrollment
United States
30 Participants77 Participants19 Participants28 Participants
Sex: Female, Male
Female
27 Participants61 Participants12 Participants22 Participants
Sex: Female, Male
Male
3 Participants16 Participants7 Participants6 Participants
Systolic Blood Pressure115.9 mmHg
STANDARD_DEVIATION 14.4
118.0 mmHg
STANDARD_DEVIATION 17.9
120.3 mmHg
STANDARD_DEVIATION 23.4
118.6 mmHg
STANDARD_DEVIATION 17.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 280 / 19
other
Total, other adverse events
0 / 300 / 280 / 19
serious
Total, serious adverse events
0 / 300 / 280 / 19

Outcome results

Primary

Systolic Blood Pressure (SBP)

Systolic blood pressure measured with ambulatory blood pressure monitors in mmHg.

Time frame: Over 2 hour exposure period, we measured SBP after 20 minutes with the objective to assess change in SBP in a time series of measurements over that time period.

ArmMeasureValue (MEAN)Dispersion
High ExposureSystolic Blood Pressure (SBP)122.3 mmHgStandard Error 0.8
Medium ExposureSystolic Blood Pressure (SBP)120.83 mmHgStandard Error 0.7
Low ExposureSystolic Blood Pressure (SBP)119.9 mmHgStandard Error 0.8
Secondary

Diastolic Blood Pressure (DBP)

The unit of measurement, mmHg for the diastolic blood pressure.

Time frame: Over a 2 hour exposure period with the objective to assess change in DBP measured after 10 minutes in a time series of measurements over that time period.

ArmMeasureValue (MEAN)Dispersion
High ExposureDiastolic Blood Pressure (DBP)69.9 mmHgStandard Error 0.5
Medium ExposureDiastolic Blood Pressure (DBP)70.4 mmHgStandard Error 0.5
Low ExposureDiastolic Blood Pressure (DBP)71.0 mmHgStandard Error 0.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026