Effect of Commute Traffic on Vascular Function

NCT ID: NCT05454930

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-12-31

Brief Summary

The investigators will assess the vascular effects of riding in a car in heavily trafficked roadways, and whether filtering the car's air reduces those effects.

Detailed Description

In this double-blind, crossover trial, randomized to order, recruited participants will be screened and then will accompany the study team on three typical commutes on separate days with sufficient washout (i.e., three weeks) between drives. One day this will occur with an effective filter system in the vehicle and the other two days without effective filtration; ineffective filtration is the most typical actual vehicle condition. Subjects will be unaware of the filtration conditions of the commute on that day. Each subject's experimental sessions will occur at the same time of day and will be separated by at least 21 days. The two sessions (either filtered air or traffic-derived entrained air) will be 120 minutes in duration and will encompass routes on heavily traveled roadways in the Seattle area. Before subjects begin the commute trials, they will go through the consent process and a series of screening tests. The study investigators will assess a series of measures regarding vascular function before and after each drive.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Typical Commute

Participants spend two hours in automobile, on heavily trafficked roadways, without active filtration of air pollutants

Group Type: NO_INTERVENTION

No interventions assigned to this group

Typical Commute, Filtered Air

Participants spend two hours in automobile, on heavily trafficked roadways, with active filtration of air pollutants

Group Type: OTHER

Filtered Air

Intervention Type: OTHER

The vehicle is fitted with a (High-Efficiency Particulate Absorbing, HEPA) filter device incorporating a charcoal filter, as well as an augmented cabin filter

Interventions

Filtered Air

The vehicle is fitted with a (High-Efficiency Particulate Absorbing, HEPA) filter device incorporating a charcoal filter, as well as an augmented cabin filter

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• healthy

Exclusion Criteria

• asthma,
• high blood pressure,
• diabetes,
• high cholesterol,
• other chronic conditions requiring ongoing medical care.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Environmental Protection Agency (EPA)

FED

Sponsor Role: collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Joel Daniel Kaufman

Professor, Environmental & Occupational Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Kaufman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

References

Young MT, Jansen K, Cosselman KE, Gould TR, Stewart JA, Larson T, Sack C, Vedal S, Szpiro AA, Kaufman JD. Blood Pressure Effect of Traffic-Related Air Pollution : A Crossover Trial of In-Vehicle Filtration. Ann Intern Med. 2023 Dec;176(12):1586-1594. doi: 10.7326/M23-1309. Epub 2023 Nov 28.

Reference Type: DERIVED

PMID: 38011704 (View on PubMed)

Other Identifiers

K24ES013195

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RD-83479601

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00001196

Identifier Type: -

Identifier Source: org_study_id