[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638793":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":25,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GHB","EXPERIMENTAL","Intravenous GHB (Gamma-OH) will be administered at a dose of 15 mg\u002Fkg as induction over 20 minutes (in a 100 mL NaCl bag), followed by a continuous infusion of 10 mg\u002Fkg\u002Fh over 8 hours (via an electric syringe pump) from 10:00 PM to 6:00 AM for one night.",[13],"Drug: GHB",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","A placebo in the form of 0.9% NaCl (as Gamma-OH is transparent and completely soluble), administered intravenously as a induction (after a dilution in a 100 mL NaCl bag) and then continuously (without dilution via an electric syringe pump) for 8 hours from 10:00 PM to 6:00 AM for one night.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Administration of GHB intravenously with a induction followed by a maintenance dose for 8 hours.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Administration of a placebo in the form of 0.9% NaCl intravenously, with a induction followed by a maintenance infusion for 8 hours.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Florian Blanchard, MD","CONTACT","+ 33184828065","florian.blanchard@aphp.fr",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Intensive Care Unit, Hospital Pitié Salpêtrière","Paris","Île-de-France Region","75013","France","FR",{"type":45,"coordinates":46},"Point",[47,48],2.3488,48.85341,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100638793","phase-2-electrophysiological-analysis-of-gamma-hydroxybutyrate-induced-sleep-in-intensive-care-patients-100638793",false,"NCT07596342","Electrophysiological Analysis of Gamma-Hydroxybutyrate-induced Sleep in Intensive Care Patients","Electrophysiological Analysis of Gamma-Hydroxybutyrate-induced Sleep in Intensive Care Patients: A Pilot Double-Blind Randomized Controlled Trial","GAMMA-SLEEP","Inclusion Criteria:\n\n1. Aged 18 years or older\n2. Hospitalized in the ICU for more than 48 hours\n3. Informed consent obtained from the patient\n\nExclusion Criteria:\n\n1. Unstable patient\n2. Known allergy to Gamma-Hydroxybutyrate or any of the excipients\n3. Technical impossibility of performing polysomnography\n4. Childbearing or Positive pregnancy test for women of childbearing age or breastfeeding\n5. Patient who has already received the study treatment\n6. History of chronic alcoholism\n7. Uncontrolled epilepsy despite appropriate antiepileptic treatment\n8. Traumatic brain injury or neurological lesion at risk of epilepsy in the last month\n9. Severe hypertension: SBP \\> 180 mmHg despite antihypertensive treatment\n10. Hypokalemia \\\u003C 3.5 mmol\u002FL despite potassium supplementation\n11. Bradycardia due to intra-cardiac conduction disorders\n12. Obstructive sleep apnea syndrome\n13. Sodium restriction: Salt intake \\\u003C 3g\u002F24h\n14. Patients with known or suspected succinic semialdehyde dehydrogenase (SSADH) deficiency, given the risk of GHB accumulation due to impaired endogenous metabolism.\n15. Patients receiving barbiturates at inclusion\n16. Patients receiving opioids at inclusion for non-mechanically ventilated patient\n17. Patients presenting with hypernatraemia (sodium \\> 145 mmol\u002FL) or hyperchloraemia (chloride \\> 110 mmol\u002FL) at inclusion\n18. Patients with hepatic impairment (Child-Pugh B or C)\n19. Deep sedation defined by a RASS score \\\u003C -2\n20. Presence of mental confusion: Positive CAM-ICU\n21. Moribund patient or high likelihood of death within 48 hours\n22. Legal protection: guardianship, curatorship, or judicial protection\n23. Lack of social security or on AME (state medical aid)\n24. Participation in another interventional clinical trial related to the management of sleep disorders, delirium, or sedation in the ICU.","ALL","18 Years",{"count":65,"type":66},24,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","In intensive care, sleep disturbances are extremely common and represent a major source of discomfort for patients. Restorative sleep is very limited. Beyond being the primary source of discomfort reported by patients, these sleep disturbances are associated with difficulties in weaning from mechanical ventilation, an increased risk of delirium, and potentially higher mortality. Traditional treatments artificially increase the total duration of sleep but lead to disrupted sleep architecture.\n\nGamma-hydroxybutyrate (GHB) is currently used for several sleep disorders, such as narcolepsy, due to its ability to increase restorative sleep. This medication has been used for years as a sedative in intensive care. Despite these potential benefits, the efficacy of GHB has never been evaluated for sleep disturbances in intensive care settings.\n\nThis study focuses on evaluating the effectiveness of intravenous Gamma-hydroxybutyrate (GHB) in the treatment of sleep disorders in intensive care.",[72,73],"Sleep Disorder (Disorder)","Critical Care",[75,76,77,78],"Gamma-hydroxybutyrate","Sleep disorder","ICU","Slow-wave sleep","NOT_YET_RECRUITING","2026-05-20",{"date":82,"type":83},"2026-05-22","ACTUAL",{"date":85,"type":66},"2026-06",{"date":87,"type":66},"2027-10",{"name":5,"class":6},1]