Neurobiological Correlates of Post Traumatic Stress Disorder (PTSD) During Rapid Eye Movement (REM) Sleep (REM-P)

January 14, 2013 updated by: University of Pittsburgh

Neurobiological Correlates of PTSD During REM Sleep (REM-P)

The overarching aim of this Exploratory/Developmental Research Grant Award (R21) is to explore the neurobiological correlates of PTSD during REM sleep by using state-of-the science positron emission tomography (PET) sleep imaging. This study will allow us to gain insight into the differences in sleep and waking brain mechanisms between veterans with PTSD and those without PTSD.

Study Overview

Status

Status

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

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.
Observational

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.
24

Contacts and Locations

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

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

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

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male Veterans of Operation Iraqi Freedom (OIF) and/or Operation Enduring Freedom (OEF), ages 18-50, with combat experience, who are not on medication.

Description

General Inclusion Criteria:

  • Male OIF/OEF returnees between the ages of 18 and 45 years old
  • Combat Exposure Scale score > 17
  • Not taking medications known to affect sleep or wake function for at least 2 weeks (6 weeks for fluoxetine).
  • No history of trauma before age 18

Specific Inclusion Criteria for Subjects with PTSD:

  • Meet diagnostic criteria for current PTSD according to the CAPS-1
  • CAPS-1 score is less than 80

Specific Inclusion Criteria for Subjects without PTSD:

  • Total CAPS-1 scores < 17
  • Does not meet criteria for PTSD

Exclusion Criteria:

  • Trauma occurred less than 3 months prior to study entry
  • CES score < 17
  • Taking medications known to affect sleep and / or brain glucose metabolism
  • Current diagnosis of depression as determined by the SCID or BDI score > 13
  • History of psychotic or bipolar disorder
  • Current history (within 3 months) of substance or alcohol abuse as determined by the SCID
  • Positive alcohol blood test at screening or during the PET protocol
  • Significant or unstable acute or chronic medical conditions
  • Other current sleep disorders, such as insufficient sleep syndrome, delayed sleep phase syndrome, narcolepsy, restless legs syndrome, periodic leg movement disorder, obstructive sleep apnea, and current night shift work, suspected during the structured interview. Individuals who are found to have a apnea-hypopnea index (AHI) > 10 or an index of periodic leg movements with arousal > 15 will be excluded.
  • Presence of implanted devices such as cardiac pacemaker, aneurysm clip, ear implant, shrapnel, neurostimulators or other metal devices
  • Fear of closed spaces
  • Previous radiation. Due to the risk of radiation exposure, we will exclude subjects who have had PET scans or other radiotracer exposure in the previous year.
  • History of open head injury.

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Combat Veterans with PTSD
Male Veterans of Operation Iraqi Freedom (OIF) and/or Operation Enduring Freedom (OEF), ages 18-50, with Combat Exposure Scale score > 17, who are not on medication and do not have trauma history before age 18.
Other: Sleep data recording
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
Other: PET scan - waking
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
Other: PET scan - REM Sleep
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
Combat Veterans without PTSD
Male Veterans of Operation Iraqi Freedom (OIF) and/or Operation Enduring Freedom (OEF), ages 18-50, with combat experience, who are not suffering from PTSD, and who are not on medication.
Other: Sleep data recording
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
Other: PET scan - waking
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
Other: PET scan - REM Sleep
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.

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
Time Frame
Brain glucose metabolism
Time Frame: During waking
During waking
Brain glucose metabolism
Time Frame: During REM sleep
During REM sleep

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 Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

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 1, 2009

Primary Completion (Actual)

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.
March 1, 2011

Study Completion (Actual)

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.
November 1, 2011

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).
March 26, 2009

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 27, 2009

First Posted (Estimate)

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 30, 2009

Study Record Updates

Last Update Posted (Estimate)

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.
January 16, 2013

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.
January 14, 2013

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.
January 1, 2013

More Information

Terms related to this study

Keywords

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.
  • MH083035-01

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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