[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565938":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":55,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":89,"overallStatus":101,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","The intervention arm will receive the study drug, Lemborexant 5mg, daily for 7 days post-operatively while in hospital.",[13],"Drug: Lemborexant 5 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","The Control arm will receive the placebo study drug daily for 7 days post-operatively while in hospital.",[19],"Drug: Control (placebo) group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Lemborexant 5 mg","The intervention is the oral administration of a study drug containing lemborexant 5 mg daily between 2000h and 0000h for the first 7 days following extubating\u002Finitiation criteria is met or until their hospital discharge or until the first diagnosis of delirium, whichever occurs first.\n\nInitiation criteria:\n\nI. The participant has been extubated for at least 2 hours II. all other sedative medications have been discontinued for \\>1 hour III. the participant has a Richmond Agitation and Sedation Scale (RASS) score of \\>-1 or a Pasero Opioid-induced Sedation Scale (POSS) score \\\u003C3.\n\nIf satisfactory sleep is not achieved with the 5 mg dose of the study drug, as defined by a Richards Campbell Sleep Score \\\u003C50 within 1 hour, another insomnia medication may be administered on participant request and clinician judgement.\n\nIf participants develop delirium, the study drug will be discontinued.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Control (placebo) group","The control group will receive an oral placebo tablet daily between 2000h and 0000h for the first 7 days following when initiation criteria is met or until their hospital discharge, whichever occurs first.\n\nInitiation criteria:\n\nI. The participant has been extubated for at least 2 hours II. all other sedative medications have been discontinued for \\>1 hour III. the participant has a Richmond Agitation and Sedation Scale (RASS) score of \\>-1 or a Pasero Opioid-induced Sedation Scale (POSS) score \\\u003C3.\n\nIf satisfactory sleep is not achieved with the 5 mg dose of the study drug, as defined by a Richards Campbell Sleep Score \\\u003C50 within 1 hour, another insomnia medication may be administered on participant request and clinician judgement.\n\nIf participants develop delirium, the study drug will be discontinued.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ron Ree, MD","CONTACT","604-561-8348","ronmree@gmail.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":26},"St. Paul's Hospital","Vancouver","British Columbia","V6Z1Y6","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-123.11934,49.24966,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ron Ree","Clinical Associate Professor",[56,59,62],{"name":57,"class":58},"Eisai Inc.","INDUSTRY",{"name":60,"class":61},"Providence Health Care, British Columbia","UNKNOWN",{"name":63,"class":61},"St. Paul's Hospital, Vancouver (Providence Health Care)","100565938","phase-2-lemborexant-to-prevent-post-operative-delirium-in-cardiac-surgery-patients-100565938",false,"NCT06648681","Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients","A Randomized Trial of Lemborexant for the Prevention of Delirium After Cardiac Surgery (PROTEX): A Pilot Study","PROTEX","Inclusion Criteria:\n\n* Admitted to hospital following open cardiac surgery through midline sternotomy\n\nExclusion Criteria:\n\n* ● Known severe obstructive sleep apnea diagnosed by polysomnography or STOPBANG score \\> 5\n\n  * Periodic limb movement disorder or restless legs syndrome\n  * Narcolepsy\n  * Somnolence (Pasero Opioid Sedation Scale (POSS) \\>2)\n  * Current alcohol or substance use disorder as defined by the DSM-V\n  * Patient already taking moderate or strong CYP3A inhibitors\n  * Frequent use of medications for insomnia defined as \\>4 days per week.\n  * Liver failure (Child-Pugh score B or C)\n  * Renal failure (eGFR\\\u003C30 ml\u002Fmin\u002F1.73 m2)\n  * Pre-existing delirium (ICDSC score \\>3 or CAM\u002FCAM-ICU positive) at time of consent\n  * BMI\\>40 kg\u002Fm2\n  * Known allergy or hypersensitivity to study drug\n  * Inability to communicate in English","ALL","61 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Lembrorexant is an orexin antagonist, originally approved for sleep, that may also reduce the incidence of delirium. The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium, and improving sleep.",[82,83,84,85,86,87,88],"Delirium - Postoperative","Cardiac Surgery","Cardiac Surgery Subjects","Orexin Antagonist","Feasibility Studies","Sleep","In-hospital Mortality",[90,91,92,93,94,95,96,97,98,99,100],"lemborexant","Postoperative Delirium","sleep medication","ICDSC","CAM","cardiac surgery","sleep aid","open heart surgery","delirium","sleep quality","Richards-Campbell Sleep Questionnaire","NOT_YET_RECRUITING","2025-04-18",{"date":104,"type":105},"2025-04-23","ACTUAL",{"date":107,"type":76},"2025-05-01",{"date":109,"type":76},"2027-04-30",{"name":5,"class":6},1]