[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574994":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":44,"centralContacts":52,"locations":62,"responsibleParty":73,"collaborators":11,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":11,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients in a vegetative state","EXPERIMENTAL",null,[13,14,15],"Other: Actimetry","Other: Subjective assessments","Other: questionnaire",{"label":17,"type":10,"description":11,"interventionNames":18},"Patients in a minimally conscious state",[13,14,15],[20,24,28,32,35,38,41],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"Actimetry","actimetry will be performed continuously during these 104 hours.",[17,9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Subjective assessments","The subjective assessments of the patient's awake\u002Fsleep state will be collected every 2 hours during the night and at least 3 times during the day, for a total of at least 8 assessments per 24-hour period, over a duration of 104 consecutive hours (slightly more than 4 days, starting at midnight and ending at 8 :00 AM, to cover 4 full days and 4 full nights).",[17,9],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"questionnaire","MOCA : Montreal Cognitive Assessment",[17,9],{"type":6,"name":29,"description":33,"armGroupLabels":34,"otherNames":11},"SF-36 The Short Form (36)",[17,9],{"type":6,"name":29,"description":36,"armGroupLabels":37,"otherNames":11},"CRS-R (Coma Recovery Scale-Revised)",[17,9],{"type":6,"name":29,"description":39,"armGroupLabels":40,"otherNames":11},"GOSE (Glasgow Outcome Scale-Extended)",[17,9],{"type":6,"name":29,"description":42,"armGroupLabels":43,"otherNames":11},"GCS (Glasgow Coma Scale)",[17,9],[45,49],{"name":46,"affiliation":47,"role":48},"Jacques LUAUTE, Professor","Hôpital Neurologique Pierre Wertheimer, Service de Service de Rééducation Post-Réanimation","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":51,"role":48},"Florent GOBERT, Doctor","Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique",[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Jacques LUAUTE, professor","CONTACT","04.78.86.51.87","33","jacques.luaute@chu-lyon.fr",{"name":60,"role":55,"phone":11,"phoneExt":11,"email":61},"Anne-Laure CHARLOIS","anne-laure.charlois@chu-lyon.fr",[63],{"facility":51,"status":11,"city":64,"state":11,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":11,"geoPoint":11,"contacts":68},"Bron, France","69500","France","FR",[69,72],{"name":70,"role":55,"phone":56,"phoneExt":71,"email":58},"Jacques LUAUTE","+33",{"name":70,"role":55,"phone":11,"phoneExt":11,"email":11},{"type":74,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100574994","characterization-of-the-sleep-wake-cycle-in-traumatic-brain-injury-patients-with-a-disorder-of-consciousness-100574994",false,"NCT06766513","Characterization of the Sleep-Wake Cycle in Traumatic Brain Injury Patients with a Disorder of Consciousness","SLEEPDOC","Inclusion Criteria:\n\n* Admission to the Post-Resuscitation Rehabilitation Unit or the Neurological Intensive Care Unit\n* Consciousness disorders: Vegetative State or Minimally Conscious State (according to the CRS-R)\n* Traumatic brain injury\n* Patient aged 18 years or older\n* Presence of relatives able to express non-opposition to the study\n* Subjects affiliated with a social security scheme (or beneficiaries)\n\nExclusion Criteria:\n\n* Admission for status epilepticus\n* Individuals admitted to a healthcare or social care facility for purposes other than research\n* Adults under legal protection measures (guardianship, conservatorship)\n* Individuals not affiliated with a social security scheme or not benefiting from a similar scheme","ALL","18 Years",{"count":85,"type":86},40,"ESTIMATED","INTERVENTIONAL",[89],"NA","Each year in France, 160,000 peoples suffer from a mild or severe traumatic brain injury (TBI). Sleep plays a crucial role in the process of brain plasticity, which is essential for neurological and cognitive recovery. However, the sleep-wake cycle is rarely, if ever, evaluated in patients with TBI and consciousness disorders within Post-Resuscitation Rehabilitation Units (SRPR). Caregivers develop, on a daily basis, an intuitive understanding of the patient's overall condition. This expertise deserves to be validated using objective sleep assessment tools (actigraphy). If proven accurate, it could lead to the implementation of a sleep-wake cycle evaluation protocol within SRPRs.",[92,93],"Trauma, Nervous System","Brain Trauma",[95,96,97,98],"Traumatic brain injury","Disorders of consciousness","Vegetative State","Minimally Conscious State","NOT_YET_RECRUITING","2025-01-08",{"date":102,"type":103},"2025-01-09","ACTUAL",{"date":105,"type":86},"2025-02-01",{"date":107,"type":86},"2028-08-01",{"name":5,"class":6},1]