[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523246":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":48,"collaborators":22,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":22,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":22,"maxAge":22,"enrollmentInfo":59,"targetDuration":22,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":22,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":60},{"fullName":5,"class":6},"Nova Scotia Health Authority","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"lemborexant","EXPERIMENTAL","The study will be an N of 1 trial over 8 weeks were treatment with lemborexant being alternated with a placebo in an \"ABBABAAB\" format.",[13],"Drug: Lemborexant 5 MG",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Lemborexant 5 MG","The participant will receive 8 weeks of treatment Week 1 = placebo Week 2 = lemborexant 5mg Week 3 = lemborexant 10 mg Week 4 = placebo Week 5 = lemborexant 10 mg Week 6 = placebo Week 7 = placebo Week 8 = lemborexant 10 mg",[9],[21],"Lemborexant 10 MG",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Shanna C Trenaman, BScPharm, PhD","CONTACT","19024310559","shanna.trenaman@dal.ca",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Nova Scotia Health","RECRUITING","Halifax","Nova Scotia","B3H 2E1","Canada","CA",{"type":39,"coordinates":40},"Point",[41,42],-63.57688,44.64269,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":47,"phoneExt":22,"email":28},"Shanna C Trenaman","1902310559",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Shanna Trenaman","Dr.","100523246","phase-4-lemborexant-for-insomnia-in-a-patient-with-dementia-an-n-of-1-trial-100523246",false,"NCT06093126","Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial","Inclusion Criteria:\n\n* Identified by clinician investigator to have early-onset dementia and a significant component of insomnia.\n\nExclusion Criteria:\n\n* Known sleep disorders that are contraindications for orexin antagonist therapy.","ALL",{"count":60,"type":61},1,"ESTIMATED","INTERVENTIONAL",[64],"PHASE4","Insomnia is a highly common, chronic disorder that is distressful for the patient but also for caregivers and can give rise to a heavy burden on the healthcare team. Sleeping aids like benzodiazepines and other sedatives (e.g., zolpidem, zopiclone) have been widely used to help treat insomnia. However, sleeping aids are also known to cause adverse drug reactions such as drowsiness and dizziness, that increases the risk of falls, driving impairment, visual impairment, cognitive impairment, and upon discontinuation may cause paradoxical rebound insomnia, delirium, and nightmares all of which exacerbate the initial insomnia. All of the negative aspects of sleeping aid use are exaggerated for older, frail adults.\n\nSome patients experience an early (young-age) onset dementia with a substantial component of insomnia. Due to the many risks associated with traditional sleeping aids they are often inappropriate in adults living with cognitive impairment and\u002For frailty. Lemborexant comes from a new class of medications for insomnia. Lemborexant is a dual orexin receptor antagonist that blocks the binding of wake-promoting neuropeptides orexin A and orexin B to their receptors orexin 1 receptor (OX1R) and orexin 2 receptor (OX2R), which is thought to suppress wake drive. Unlike other traditional sleeping aids, lemborexant has not shown to be significantly associated with driving impairment, rebound insomnia, or dependence\u002Fwithdrawal symptoms. Also, in clinical trials it only rarely causes the types of adverse events associated with benzodiazepines and other traditional sedatives and is less often associated with discontinuations due to adverse events.\n\nWhile lemborexant is available on the Canadian market it is unclear how this medication will be tolerated by patients living with an early onset dementia. Understanding the effectiveness and tolerability of lemborexant will be helpful in an N of 1 trial to understand the details of effect and effectiveness in individual patients.",[67,68,69],"Insomnia","Dementia","Frontotemporal Dementia","2025-02-20",{"date":72,"type":73},"2025-02-21","ACTUAL",{"date":75,"type":73},"2023-12-11",{"date":77,"type":61},"2028-12-11",{"name":5,"class":6}]