Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-30 @ 2:36 AM
Study NCT ID:
NCT00871650
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2009-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurobiological Correlates of Post Traumatic Stress Disorder (PTSD) During Rapid Eye Movement (REM) Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-14', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-27', 'lastUpdatePostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain glucose metabolism', 'timeFrame': 'During waking'}, {'measure': 'Brain glucose metabolism', 'timeFrame': 'During REM sleep'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Post Traumatic Stress Disorder', 'PTSD', 'Brain', 'Imaging', 'PET', 'Neural', 'Sleep', 'REM Sleep'], 'conditions': ['Post-Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '24893322', 'type': 'DERIVED', 'citation': 'Stocker RP, Cieply MA, Paul B, Khan H, Henry L, Kontos AP, Germain A. Combat-related blast exposure and traumatic brain injury influence brain glucose metabolism during REM sleep in military veterans. Neuroimage. 2014 Oct 1;99:207-14. doi: 10.1016/j.neuroimage.2014.05.067. Epub 2014 Jun 2.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male Veterans of Operation Iraqi Freedom (OIF) and/or Operation Enduring Freedom (OEF), ages 18-50, with combat experience, who are not on medication.', 'healthyVolunteers': True, 'eligibilityCriteria': 'General Inclusion Criteria:\n\n* Male OIF/OEF returnees between the ages of 18 and 45 years old\n* Combat Exposure Scale score \\> 17\n* Not taking medications known to affect sleep or wake function for at least 2 weeks (6 weeks for fluoxetine).\n* No history of trauma before age 18\n\nSpecific Inclusion Criteria for Subjects with PTSD:\n\n* Meet diagnostic criteria for current PTSD according to the CAPS-1\n* CAPS-1 score is less than 80\n\nSpecific Inclusion Criteria for Subjects without PTSD:\n\n* Total CAPS-1 scores \\< 17\n* Does not meet criteria for PTSD\n\nExclusion Criteria:\n\n* Trauma occurred less than 3 months prior to study entry\n* CES score \\< 17\n* Taking medications known to affect sleep and / or brain glucose metabolism\n* Current diagnosis of depression as determined by the SCID or BDI score \\> 13\n* History of psychotic or bipolar disorder\n* Current history (within 3 months) of substance or alcohol abuse as determined by the SCID\n* Positive alcohol blood test at screening or during the PET protocol\n* Significant or unstable acute or chronic medical conditions\n* 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.\n* Presence of implanted devices such as cardiac pacemaker, aneurysm clip, ear implant, shrapnel, neurostimulators or other metal devices\n* Fear of closed spaces\n* 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.\n* History of open head injury.'}, 'identificationModule': {'nctId': 'NCT00871650', 'acronym': 'REM-P', 'briefTitle': 'Neurobiological Correlates of Post Traumatic Stress Disorder (PTSD) During Rapid Eye Movement (REM) Sleep', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Neurobiological Correlates of PTSD During REM Sleep (REM-P)', 'orgStudyIdInfo': {'id': 'MH083035-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Combat Veterans with PTSD', 'description': '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.', 'interventionNames': ['Other: Sleep data recording', 'Other: PET scan - waking', 'Other: PET scan - REM Sleep']}, {'label': 'Combat Veterans without PTSD', 'description': '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.', 'interventionNames': ['Other: Sleep data recording', 'Other: PET scan - waking', 'Other: PET scan - REM Sleep']}], 'interventions': [{'name': 'Sleep data recording', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Combat Veterans with PTSD', 'Combat Veterans without PTSD']}, {'name': 'PET scan - waking', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Combat Veterans with PTSD', 'Combat Veterans without PTSD']}, {'name': 'PET scan - REM Sleep', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Combat Veterans with PTSD', 'Combat Veterans without PTSD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}