[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659773":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":40,"interventions":48,"overallOfficials":57,"centralContacts":62,"locations":72,"responsibleParty":89,"collaborators":34,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":34,"enrollmentInfo":100,"targetDuration":34,"studyType":103,"phases":104,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":114,"whyStopped":34,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Median continuous sleep time","Median duration (in minutes) of continuous sleep episodes ≥10 minutes measured using EEG recordings via Sleepscan®","Nights 1, 2, and 3 after ICU admission and the last night before ICU discharge, assessed up to 90 days after ICU admission.",[14,17,20,23,27,31],{"measure":15,"description":16,"timeFrame":12},"Total sleep time","Median total sleep time (minutes) measured by EEG",{"measure":18,"description":19,"timeFrame":12},"Deep sleep time","Median duration of deep sleep stages",{"measure":21,"description":22,"timeFrame":12},"Micro-arousal index","Number of micro-arousals per hour",{"measure":24,"description":25,"timeFrame":26},"ICU length of stay","Duration of ICU hospitalization (days)","At ICU discharge (up to 90 days after ICU admission.)",{"measure":28,"description":29,"timeFrame":30},"SOFA score evolution","Organ failure assessment score at ICU admission and discharge","At ICU admission and ICU discharge (up to 90 days after ICU admission.)",{"measure":32,"description":33,"timeFrame":12},"Sleep comparison (ventilated vs non-ventilated patients)","Median total sleep time comparison between groups",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":6,"observationalModel":34,"timePerspective":34,"maskingInfo":38},"NA","SINGLE_GROUP",{"masking":39,"maskingDescription":34,"whoMasked":34},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Sleepscan device and actigraphy","EXPERIMENTAL","Adult ICU patients with expected stay ≥4 days undergoing repeated sleep monitoring using Sleepscan® device and actigraphy, without therapeutic intervention.",[46,47],"Other: Sleep monitoring using Sleepscan®","Other: Actigraphy",[49,53],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":34},"Sleep monitoring using Sleepscan®","Non-invasive EEG-based sleep monitoring using the Sleepscan® device. Three scalp electrodes (frontal, mastoid, central) are applied with a headband for overnight recordings (12 hours, 8 PM-8 AM) during four nights (N1, N2, N3, and last night before discharge). Data are automatically analyzed and secondarily reviewed.",[42],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":34},"Actigraphy","An actimeter placed on the ankle to measure motor activity and estimate sleep-wake cycles during the first 72 hours and the last 24 hours of ICU stay.",[42],[58],{"name":59,"affiliation":60,"role":61},"Frédéric ROCHE, MD","CHU DE SAINT-ETIENNE","PRINCIPAL_INVESTIGATOR",[63,68],{"name":59,"role":64,"phone":65,"phoneExt":66,"email":67},"CONTACT","(0)477828695","+33","frederic.roche@chu-st-etienne.fr",{"name":69,"role":64,"phone":70,"phoneExt":66,"email":71},"Guillaume Thiéry, MD","(0)477127853","Guillaume.Thiery@chu-st-etienne.fr",[73],{"facility":74,"status":34,"city":75,"state":34,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"CHU de Saint-Etienne","Saint-Etienne","42055","France","FR",{"type":80,"coordinates":81},"Point",[82,83],4.39,45.43389,{"lat":83,"lon":82},[86,87],{"name":59,"role":64,"phone":65,"phoneExt":66,"email":67},{"name":69,"role":88,"phone":34,"phoneExt":34,"email":34},"SUB_INVESTIGATOR",{"type":90,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100659773","evolution-of-sleep-in-intensive-care-unit-patients-100659773",false,"NCT07867912","Evolution of Sleep in Intensive Care Unit Patients","SOMNOREA","Inclusion Criteria:\n\n* Adult patients\n* Affiliated to a social security system\n* Informed consent obtained (patient or proxy if necessary)\n* Expected ICU stay ≥ 4 days\n\nExclusion Criteria:\n\n* Acute brain injury or neurological disease (stroke, meningitis, neurodegenerative disease)\n* Severe psychiatric disorders, dementia, or agitation Sedated patients (RASS \\\u003C 0)\n* Patients under legal protection (guardianship)\n* Pregnant women\n* Skin lesions preventing electrode placement","ALL","18 Years",{"count":101,"type":102},40,"ESTIMATED","INTERVENTIONAL",[36],"Sleep plays a key role in immune, metabolic, and neurological regulation, particularly in critically ill patients. However, the intensive care environment significantly disrupts sleep due to noise, light exposure, and frequent medical interventions, leading to circadian rhythm disturbances. Poor sleep in ICU patients is associated with increased morbidity, mortality, prolonged mechanical ventilation, and long-term psychological complications. Current studies report fragmented sleep with reduced deep sleep stages but are limited by short monitoring periods and small sample sizes. No study has yet assessed longitudinal sleep evolution throughout ICU stay. This study aims to characterize sleep dynamics from the acute phase to recovery using a simplified EEG device (Sleepscan®). Sleep will be recorded during the first three nights and the last night before ICU discharge. Environmental factors (noise, light) and clinical data will also be collected. This longitudinal intra-individual analysis will identify critical periods of sleep disruption. Results may guide future targeted interventions to improve sleep quality and patient outcomes in ICU.",[107,108],"ICU","Sleep Deprivation",[107,110,111,112,54,113],"EEG","Circadian rhythm","Sleep deprivation","Sleepscan","NOT_YET_RECRUITING","2026-10-05",{"date":117,"type":118},"2026-10-09","ACTUAL",{"date":120,"type":102},"2026-12",{"date":122,"type":102},"2027-12",{"name":5,"class":6},1]