Mental Stress & Diesel Exhaust on Cardiovascular Health

NCT ID: NCT03467997

Last Updated: 2018-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-22

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study uses an experimental design to conduct a double-blind, randomized, crossover study where participants receive both diesel exhaust and a mental stress test in a controlled setting. My hypothesis is that the synergistic effect of stress and air pollution will result in higher levels of stress and inflammation (measured via biological markers) as well as poorer cardiovascular disease related outcomes compared to the independent effect of each exposure separately.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure Inflammation Catecholamines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Filtered Air

Subjects sit in a room for two hours breathing in filtered air which resembles levels of air pollution found in the ambient environment

Group Type NO_INTERVENTION

No interventions assigned to this group

Diesel Exhaust

Subjects sit in a room for two hours breathing in diesel exhaust at 200 micrograms of meter cubed.

Group Type ACTIVE_COMPARATOR

Diesel exhaust

Intervention Type OTHER

Diesel exhaust is an air pollutant found in the environment and produced by cars, trucks and other transportation modes (e.g. trains, planes).

TSST/Stress only

Subjects undergo a mental stress test, known as the Trier Social Stress Test (TSST), which involves a public speaking and math task.

Group Type ACTIVE_COMPARATOR

Trier social stress test

Intervention Type BEHAVIORAL

Subjects are asked to give a 5 minute speech on a topic selected by the investigator. Then they are asked to subtract 7 from 758.

Diesel Exhaust and stress

Subjects sit in a room for two hours breathing in diesel exhaust at 200 micrograms of meter cubed and are subject to a mental stress test (TSST) which involves a public speaking and math task.

Group Type ACTIVE_COMPARATOR

Trier social stress test

Intervention Type BEHAVIORAL

Subjects are asked to give a 5 minute speech on a topic selected by the investigator. Then they are asked to subtract 7 from 758.

Diesel exhaust

Intervention Type OTHER

Diesel exhaust is an air pollutant found in the environment and produced by cars, trucks and other transportation modes (e.g. trains, planes).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trier social stress test

Subjects are asked to give a 5 minute speech on a topic selected by the investigator. Then they are asked to subtract 7 from 758.

Intervention Type BEHAVIORAL

Diesel exhaust

Diesel exhaust is an air pollutant found in the environment and produced by cars, trucks and other transportation modes (e.g. trains, planes).

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TSST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Non-smokers without history of high blood pressure, asthma, diabetes, high cholesterol, post-traumatic stress disorder (PTSD) or any other chronic condition that requires ongoing care.

Exclusion Criteria

1. Smoking: We rule out active smoking by checking urine cotinine during our study.
2. History of high blood pressure: We objectively measure BP during in-person screening and exclude those with blood pressure (\>130/85 mmHg).
3. Asthmatic: Spirometry is done at screening to rule out asthma.
4. Diabetic: We obtain fasting blood sugar to rule out diabetes at screening (\>125 mg/dL)
5. Cholesterol: We obtain fasting blood lipid levels to rule out hypercholesterolemia at screening (\>200 mg/dL).
6. History of PTSD: Subjects will be asked about prior PTSD diagnosis during the phone and in person screen.
7. Any other chronic condition requiring ongoing care based on medication use.
8. A body mass index (weight in kilograms divided by height in meters squared) greater than 26 and less than 18.5
9. A female of childbearing age with a positive pregnancy test
10. A female of childbearing age who is unwilling to use effective contraception during the study
Minimum Eligible Age

22 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anjum Hajat

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anjum Hajat, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington Diesel Exhaust Facility

Seattle, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Karen Jansen, MS

Role: CONTACT

206-685-6392

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Karen Jansen, MS

Role: primary

206-685-6392

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R00ES023498

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002051

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.