Air PollutionNCT04029129
Reducing Traffic Pollution Exposure Improves Blood Pressure
A study testing Air filtration and building envelop modifications in people with Air Pollution, run by UConn Health at 1 site in United States.
Trial summary
This randomized trial assessed the effect of modifying building envelop and level of air filtration on blood pressure over two hour exposure sessions. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Air Pollution
- What is being tested?
- Air filtration and building envelop modifications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criterion was age 40-75 years.
- There was a preference for people who were otherwise healthy, but overweight or obese.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Farmington, Connecticut, 06030
About this study
Official title: Near Highway Pollution: From Research to Action
This randomized trial assessed the effect of modifying building envelop and level of air filtration on blood pressure over two hour exposure sessions.
Read the 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.
- Conditions
- Air Pollution
- Being tested
- Air filtration and building envelop modifications
- Keywords
- Traffic-related air pollution, Air filtration, Blood pressure, Controlled exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air filtration and building envelop modificationsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High exposure | Experimental | Ambient air was allowed freely into the room. Receives: Other: Air filtration and building envelop modifications |
| Medium exposure | Experimental | Limited air filtration was used to partially reduce levels of pollution in the room relative to outside. Receives: Other: Air filtration and building envelop modifications |
| Low exposure | Experimental | Doors and windows were closed and sealed and full filtration was used to maximally reduce pollution in the room. Receives: Other: Air filtration and building envelop modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure (SBP)
Systolic blood pressure measured with ambulatory blood pressure monitors in mmHg.
Measured: 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.
Secondary outcomes (1)
Diastolic Blood Pressure (DBP)
The unit of measurement, mmHg for the diastolic blood pressure.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Mar 2018
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Air PollutionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross over trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Douglas Brugge, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029129
- Sponsor's protocol ID
- 19X-183=1
- Other IDs
- R01ES026980
- Status last verified
- Sep 2023
- First submitted
- 16 Jul 2019
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Highway Pollution: From Research to Action
- ClinicalTrials.gov ID
- NCT04029129
- Acronym / sponsor ID
- 19X-183=1
- Conditions
- Air Pollution
- Keywords
- Traffic-related air pollution, Air filtration, Blood pressure, Controlled exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized cross over trial
| Arm | Type | Receives |
|---|---|---|
| High exposure | Experimental | Other: Air filtration and building envelop modificationsAmbient air was allowed freely into the room. |
| Medium exposure | Experimental | Other: Air filtration and building envelop modificationsLimited air filtration was used to partially reduce levels of pollution in the room relative to outside. |
| Low exposure | Experimental | Other: Air filtration and building envelop modificationsDoors and windows were closed and sealed and full filtration was used to maximally reduce pollution in the room. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The inclusion criterion was age 40-75 years.
- There was a preference for people who were otherwise healthy, but overweight or obese.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air filtration and building envelop modificationsAir 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. | Other | High exposure, Low exposure, Medium exposure |
Primary outcome
Systolic Blood Pressure (SBP)
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.
Systolic blood pressure measured with ambulatory blood pressure monitors in mmHg.
1 secondary outcome
Diastolic Blood Pressure (DBP)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air filtration and building envelop modifications in people with Air Pollution, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (SBP) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.