Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT04581850
Status:
UNKNOWN
Last Update Posted:
2023-09-18
First Post:
2020-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2020-10-05', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%.', 'timeFrame': '1 month after enrollment', 'description': 'The sleep efficiency index (SEI) is defined by the ratio TST/TIB with TST being Total Sleep Time and TIB being Time In Bed.\n\nTST and TIB will be assessed objectively, at home, using a connected headband (DREEM®, Rythm Paris).\n\nA Sleep Efficiency Index (SEI) \\< 80% is considered to be a poor quality, low-efficiency night.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '40370761', 'type': 'DERIVED', 'citation': 'Saguin E, Feingold D, Sipahimalani G, Quiquempoix M, Roseau JB, Remadi M, Annette S, Guillard M, Van Beers P, Lahutte B, Leger D, Gomez-Merino D, Chennaoui M. PTSD Symptom Severity Associated With Sleep Disturbances in Military Personnel: Evidence From a Prospective Controlled Study With Ecological Recordings. Depress Anxiety. 2025 Apr 25;2025:8011375. doi: 10.1155/da/8011375. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': "Post-Traumatic Stress Disorder (PTSD) is a public health problem due to both its chronic nature and the low response rate to conventional therapies.\n\nSleep disorders are the first cause of complaint in patients with PTSD due to night awakenings, difficulty to fall asleep and nightmares.\n\nAccording to a part of the scientific community, replicative traumatic nightmares represent PTSD's basis mechanism. Traumatic nightmares generate disabling symptoms such as anxiety reactions, while maintaining the symptoms by depriving the individual of good quality sleep. Traumatic nightmares may thus be a sign of PTSD seriousness and chronicity, although their physiological basis remain poorly known.\n\nIn the military population, which is highly exposed to psychological traumatism, PTSD prevalence is very high and is associated with severe intensity patterns, a very high frequency of replicative nightmares and a low response to conventional therapies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed of patients suffering from an active PTSD and healthy individuals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Military or former military\n* Age between 18 and 65 years old\n* PTSD group : with a PTSD diagnosis\n* Control group : without any sleep, psychiatric or neurologic pathology\n\nExclusion Criteria:\n\n* Diagnosis of progressive psychiatric pathology prior to the traumatic event responsible for PTSD\n* Sleep pathology prior to the traumatic event responsible for PTSD\n* Neurological pathology or severe head injury within the last 3 years'}, 'identificationModule': {'nctId': 'NCT04581850', 'acronym': 'SOMMEPT', 'briefTitle': 'Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder', 'orgStudyIdInfo': {'id': '2020PRI01'}, 'secondaryIdInfos': [{'id': '2020-A01808-31', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PTSD patients', 'description': 'This group is composed of patients suffering from an active PTSD', 'interventionNames': ['Behavioral: Sleep recording', 'Behavioral: Cognitive tasks', 'Other: Questionnaires']}, {'label': 'Control group (healthy individuals)', 'description': 'This group is composed of healthy individuals.', 'interventionNames': ['Behavioral: Sleep recording', 'Behavioral: Cognitive tasks', 'Other: Questionnaires']}], 'interventions': [{'name': 'Sleep recording', 'type': 'BEHAVIORAL', 'description': 'Sleep is recorded at home during 7 nights in a row using a connected headband. The participant also has to fill in a sleep agenda every day.', 'armGroupLabels': ['Control group (healthy individuals)', 'PTSD patients']}, {'name': 'Cognitive tasks', 'type': 'BEHAVIORAL', 'description': 'Working memory and inhibition capacity is assessed during computer-based tasks (2-back and Go/No-Go tasks) at enrollment and 1 month after enrollment.', 'armGroupLabels': ['Control group (healthy individuals)', 'PTSD patients']}, {'name': 'Questionnaires', 'type': 'OTHER', 'description': 'The participant has to fill in several questionnaires at enrollment and 1 month after enrollment in order to assess:\n\n* PTSD severity\n* chronotype\n* Sleep quality\n* Daytime sleepiness\n* Mood state\n* Depression\n* Mental disorders and their consequences', 'armGroupLabels': ['Control group (healthy individuals)', 'PTSD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92141', 'city': 'Clamart', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie BOUSSAUD, MD', 'role': 'CONTACT', 'email': 'marie.boussaud@intradef.gouv.fr', 'phone': '141466298', 'phoneExt': '+33'}], 'facility': "Hôpoital d'Instruction des Armées Percy", 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '10230', 'city': 'Mailly-le-Camp', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre PERRIER, MD', 'role': 'CONTACT', 'email': 'pierre1.perrier@intradef.gouv.fr', 'phone': '325472512', 'phoneExt': '+33'}], 'facility': '52e Antenne Médicale', 'geoPoint': {'lat': 48.66526, 'lon': 4.21303}}, {'zip': '13384', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric PAUL, MD', 'role': 'CONTACT', 'email': 'frederic1.paul@intradef.gouv.fr', 'phone': '491617282', 'phoneExt': '+33'}], 'facility': "Hôpital d'Instruction des Armées Laveran", 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '51400', 'city': 'Mourmelon-le-Grand', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gaetan SOYERE, MD', 'role': 'CONTACT', 'email': 'gaetan.soyere@intradef.gouv.fr', 'phone': '326637438', 'phoneExt': '+33'}], 'facility': '29e Antenne Médicale', 'geoPoint': {'lat': 49.13256, 'lon': 4.3642}}, {'zip': '94160', 'city': 'Saint-Mandé', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emeric SAGUIN, MD', 'role': 'CONTACT', 'email': 'emeric.saguin@intradef.gouv.fr', 'phone': '143985440', 'phoneExt': '+33'}], 'facility': "Hôpital d'Instruction des Armées Bégin", 'geoPoint': {'lat': 48.83864, 'lon': 2.41579}}, {'zip': '83000', 'city': 'Toulon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles GHEORGHIEV, MD', 'role': 'CONTACT', 'email': 'charles.gheorghiev@intradef.gouv.fr', 'phone': '483162159', 'phoneExt': '+33'}], 'facility': "Hôpital d'Instruction des Armées Sainte-Anne", 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}], 'centralContacts': [{'name': 'Emeric SAGUIN, MD', 'role': 'CONTACT', 'email': 'emeric.saguin@intradef.gouv.fr', 'phone': '143985440', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}