Mental Stress & Diesel Exhaust on Cardiovascular Health (DESTRESS)

November 1, 2018 updated by: Anjum Hajat, University of Washington

Effects of Mental Stress and Diesel Exhaust on Cardiovascular Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Karen Jansen, MS
  • Phone Number: 206-685-6392
  • Email: kjansen@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Diesel Exhaust Facility
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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
Active Comparator: Diesel Exhaust
Subjects sit in a room for two hours breathing in diesel exhaust at 200 micrograms of meter cubed.
Other: 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).
Active Comparator: 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.
Behavioral: 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.
Other Names:
  • TSST
Active Comparator: 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.
Other: 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).
Behavioral: 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.
Other Names:
  • TSST

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in norepinephrine
Time Frame: Change in norepinephrine from baseline (pre-exposure) to immediately after exposure
Urinary norepinephrine in ng/mg
Change in norepinephrine from baseline (pre-exposure) to immediately after exposure
Change in epinephrine
Time Frame: Change in epinephrine from baseline (pre-exposure) to immediately after exposure
Urinary epinephrine in ng/mg
Change in epinephrine from baseline (pre-exposure) to immediately after exposure
Change in dopamine
Time Frame: Change in dopamine from baseline (pre-exposure) to immediately after exposure
Urinary dopamine in ng/mg
Change in dopamine from baseline (pre-exposure) to immediately after exposure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in d-dimer
Time Frame: change in d-dimer from baseline (pre-exposure) to six hours post exposure
plasma d-dimer (ug/ml) is a measure of coagulation
change in d-dimer from baseline (pre-exposure) to six hours post exposure
Change in fibrinogen
Time Frame: change in fibrinogen from baseline (pre-exposure) to six hours post exposure
plasma fibrinogen (mg/dl) is a measure of coagulation
change in fibrinogen from baseline (pre-exposure) to six hours post exposure
Change in interleukin-6 (IL-6)
Time Frame: change in IL-6 from baseline (pre-exposure) to immediately after exposure
plasma IL-6, measured in pg/ml, is a marker of inflammation
change in IL-6 from baseline (pre-exposure) to immediately after exposure
Change in tumor necrosis factor alpha (TNF-a)
Time Frame: change in TNF-a from baseline (pre-exposure) to immediately after exposure
plasma TNF-a, measured in pg/ml, is a marker of inflammation
change in TNF-a from baseline (pre-exposure) to immediately after exposure
Change in interleukin-1b (IL-1b)
Time Frame: change in IL-1b from baseline (pre-exposure) to immediately after exposure
plasma IL-1b, measured in pg/ml, is a marker of inflammation
change in IL-1b from baseline (pre-exposure) to immediately after exposure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in blood pressure
Time Frame: Change in blood pressure from baseline (pre-exposure) to 22 hours post exposure
blood pressure in mm Hg
Change in blood pressure from baseline (pre-exposure) to 22 hours post exposure
Change in heart rate
Time Frame: Change in blood pressure from baseline (pre-exposure) to 60 minutes post exposure
heart rate in beats per minute
Change in blood pressure from baseline (pre-exposure) to 60 minutes post exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Environmental Health Sciences (NIEHS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anjum Hajat, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002051
  • R00ES023498 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We may share some of the clinical data collected such as blood pressure, spirometry and other markers of cardiac function with researchers interested in addressing related study questions. Direct identifiers will not be stored or shared, but rather only de-identified bio-specimens and data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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