[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561004":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":107,"collaborators":109,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":18,"enrollmentInfo":131,"targetDuration":18,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":18,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Physician and patient intervention","EXPERIMENTAL","Patients in the intervention group will be treated by physicians, who received informative and educative materials (including videos) and training, including guidelines and implementation recommendations on how to deprescribe, on shared-decision making with patients, on how to manage sleep problems using alternative methods other than BSH. Patients receive brochures and access to videos. Communication forms are implemented to ensure continuity of care.",[13],"Other: Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements",{"label":15,"type":16,"description":17,"interventionNames":18},"Control\u002FUsual care","NO_INTERVENTION","Participants in the control group receive treatment according to standard care of the prescribing physician, who did not receive any training or additional material.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements","The intervention consists of a patient-centred intervention to help patients in deprescribing BSHs and better managing their sleep problems. The material used consists of training modules, brochures, and self-monitoring tools. There are materials for physicians and for patients.",[9],[25],{"name":26,"affiliation":27,"role":28},"Nicolas Rodondi, MD, MAS","University Hospital Bern (Inselspital)","STUDY_CHAIR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+41 31 632 00 69","nicolas.rodondi@insel.ch",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Carole E Aubert, MD, MSc","+41 31 664 24 34","caroleelodie.aubert@insel.ch",[39,52,63,74,85,96],{"facility":40,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":18},"Centre Hospitalier Universitaire CHU UCL Namur","RECRUITING","Yvoir","5530","Belgium","BE",{"type":47,"coordinates":48},"Point",[49,50],4.88059,50.3279,{"lat":50,"lon":49},{"facility":53,"status":41,"city":54,"state":18,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":62,"contacts":18},"National and Kapodistrian University of Athens","Athens","10679","Greece","GR",{"type":47,"coordinates":59},[60,61],23.72784,37.98376,{"lat":61,"lon":60},{"facility":64,"status":41,"city":65,"state":18,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":18},"Oslo University Hospital","Nydalen","4950","Norway","NO",{"type":47,"coordinates":70},[71,72],10.76667,59.95,{"lat":72,"lon":71},{"facility":75,"status":41,"city":76,"state":18,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":18},"Institute of Psychiatry and Neurology","Warsaw","02-957","Poland","PL",{"type":47,"coordinates":81},[82,83],21.01178,52.22977,{"lat":83,"lon":82},{"facility":86,"status":41,"city":87,"state":18,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":18},"Universitat Autònoma de Barcelona","Barcelona","08041","Spain","ES",{"type":47,"coordinates":92},[93,94],2.15899,41.38879,{"lat":94,"lon":93},{"facility":97,"status":41,"city":98,"state":18,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":18},"Department of General Internal Medicine, University Hospital Bern (Inselspital)","Bern","3010","Switzerland","CH",{"type":47,"coordinates":103},[104,105],7.44744,46.94809,{"lat":105,"lon":104},{"type":108,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[110,112,113,114,116,119],{"name":111,"class":6},"Universitat Autonoma de Barcelona",{"name":64,"class":6},{"name":53,"class":6},{"name":115,"class":6},"Institute of Psychiatry and Neurology, Warsaw",{"name":117,"class":118},"CHU UCL Namur","UNKNOWN",{"name":120,"class":6},"Université Catholique de Louvain","100561004","improving-patient-safety-by-supporting-older-adults-in-managing-sleep-problems-100561004",false,"NCT06584513","Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.","Implementing a Patient-centred and Evidence-based Intervention to Reduce BEnzodiazepine and Sedative-hypnotic Use to Improve Patient SAFEty and Quality of Care (BE-SAFE)","BE-SAFE","Inclusion Criteria:\n\n* ≥65 years old\n* BSH (ATC codes N05BA, N05CF, N05CD, and N03AE01) use on average ≥3 times a week during the last 3 months prior to providing informed consent, as self-reported by the patient or by the informal carer\n* Taking BSH for sleep problems, as self-reported by the patient or by the informal carer\n\nExclusion Criteria:\n\n* Indication for BSH appropriate or withdrawal dangerous, based on available documents (diagnosis list) or General Practitioner (GP) information:\n\n  * Current use of BSH for alcohol withdrawal\n  * BSH use in the context of addiction\n  * Rapid Eye Movement (REM) sleep Behaviour Disorders\n  * Active diagnosis of severe non-REM-related parasomnias with risk of self-damage or giving harm to others or with high frequency or social embarrassment\n  * Epilepsy (all forms, because of risk of seizures by sleep deprivation)\n  * Current active diagnosis of severe general or specific anxiety disorder (including obsessive compulsive disorder, social phobia, post-traumatic stress disorder, panic disorder with or without agoraphobia)\n  * Current active diagnosis of psychotic disorder with or without antipsychotic medication\n  * Current active diagnosis of severe depression with or without major anxiety symptoms\n  * Current active diagnosis of bipolar disorder with or without major anxiety symptoms\n  * Acute suicidal ideation\n* Current formal active tapering process of BSHs supported by a physician\n* Planned admission to palliative care within 24 hours of inclusion or estimated life-expectancy of less than 12 months i.e., patient is in a state or has a diagnosis where the cluster physician would not be surprised if patient dies within the next months (this criterion is relatively vague and subjective but because there is no validated prognostic score, it is justified)\n* Inability to provide informed consent (e.g., because of cognitive impairment), except if a proxy can provide consent, be actively involved in the study, and patient shows no sign of disagreement","ALL","65 Years",{"count":132,"type":133},470,"ESTIMATED","INTERVENTIONAL",[136],"NA","Among older adults (≥65 years), use of sleeping pills, such as benzodiazepines and other sedative-hypnotics, to treat sleep problems is common. While sleeping pills are effective in the first few weeks of use, their effect diminishes significantly after that. Especially older adults are susceptible to significant adverse effects of sleep pills, yet stopping sleeping pills remains challenging. BE-SAFE aims to conduct a randomised study testing a patient-centred intervention to reduce sleeping pill use and to improve patient safety and quality of care focusing on implementation aspects. The intervention addresses knowledge and practice gaps related to discontinuation of sleeping pills in older adults with sleep problems.",[139,140],"Benzodiazepines Deprescribing","Sleep Problems","2025-09-29",{"date":143,"type":144},"2025-09-30","ACTUAL",{"date":146,"type":144},"2024-11-18",{"date":148,"type":133},"2026-02-01",{"name":5,"class":6},6]