NCT04029129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

July 16, 2019

Results QC Date

June 15, 2023

Last Update Submit

September 25, 2023

Conditions

Keywords

Traffic-related air pollutionAir filtrationBlood pressureControlled exposure

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure (SBP)

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

    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)

    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.

Study Arms (3)

High exposure

EXPERIMENTAL

Ambient air was allowed freely into the room.

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.

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.

Other: Air filtration and building envelop modifications

Interventions

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.

High exposureLow exposureMedium exposure

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • There was a preference for people who were otherwise healthy, but overweight or obese.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Results Point of Contact

Title
Dr. Douglas Brugge
Organization
UConnHealth

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized cross over trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 23, 2019

Study Start

March 1, 2018

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

September 28, 2023

Results First Posted

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations