[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550813":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":23,"locations":34,"responsibleParty":50,"collaborators":52,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":18,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of Bergen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual darkness","EXPERIMENTAL","Exclusive exposure to light deprived of blue wavelengths from 19.00-08.00 for 14 consecutive days as add-on to treatment as usual (TAU). This will be provided in an ordinary part of the hospital ward with circadian lightening delivered by Chromawiso. This lightening is CE approved. The intervention will be delivered in two separate patient units, each of them will include one living room, one bedroom and a bathroom, area ranging from 58m2- 60 m2. If patients are able to wear blue blocking glasses (amber lenses), they can stay outside the units from 19.00-08.00. Between 08.00-19.00 the patients in the intervention groups can stay inside or outside the units as they wish.",[13],"Other: Virtual darkness",{"label":15,"type":16,"description":17,"interventionNames":18},"Control condition","NO_INTERVENTION","Treatment as usual for agitation in specialized dementia health services encompasses use of psychotropic drugs (anxiolytic agents, antipsychotic agents, antidementia agents), environmental interventions, music therapy and use of medical restraints",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"Chronotheraphy",[9],[24,30],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},"Line Iden Berge, M.D., PhD.","CONTACT","+4798857354","+47","line.berge@uib.no",{"name":31,"role":26,"phone":32,"phoneExt":28,"email":33},"Sunniva Vibe Skagen, M. Psychol","+47 94154315","sunniva.skagen@uib.no",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":18,"geoPoint":18,"contacts":43},"NKS Olaviken Gerontopsychiatric Hospital","RECRUITING","Askøy","Erdal","5306","Norway","NO",[44,48],{"name":45,"role":26,"phone":46,"phoneExt":18,"email":47},"Line I Berge, Ph.D.","98857354","Line.berge@uib.no",{"name":49,"role":26,"phone":18,"phoneExt":18,"email":33},"Sunniva Vibe Skagen, Cand.Psychol",{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[53],{"name":36,"class":6},"100550813","virtual-darkness-theraphy-for-agitation-in-dementia-100550813",false,"NCT06451952","Virtual Darkness Theraphy for Agitation in Dementia","Virtual Darkness and Digital Phenotyping in Specialized and Municipal Dementia Care: The DARK.DEM Randomized Controlled Trial","DARKDEM","Inclusion Criteria:\n\n* Patients admitted to NKS Olaviken gerontopsychiatric hospital\n* Diagnosis of dementia, all stages and etiologies,\n* ≥50 years\n* both genders\n* Clinically significant agitation (CMAI ≥45)\n\nExclusion Criteria:\n\n* Total blindness\u002Fdiminished bilateral red reflex.\n* Use of melatonin\n* Clinically significant pain (MOBID-2≥3)","ALL","50 Years",{"count":65,"type":66},72,"ESTIMATED","INTERVENTIONAL",[69],"NA","Behavioral and psychological symptoms of dementia (BPSD) such as anxiety, depression, psychosis and agitation, are prevalent, often treatment resistant, resource demanding and significantly deteriorates cognition, independency, quality of life and mortality in people with dementia.\n\nThe DARK.DEM trial aims at developing new diagnostics and treatment for BPSD in both specialized and municipal dementia care.\n\nThe investigators will develop digital phenotyping by determining the convergent validity of data from a smartwatch against established psychometric scales for BPSD for patients admitted to NKS Olaviken gerontopsychiatric hospital.\n\nThe investigators will conduct an open label single blinded randomized controlled trial to determine the effectiveness, feasibility and safety of virtual darkness as adjunctive treatment of agitation in patients with dementia admitted to the hospital. The investigators will randomize minimum 72 patients to treatment as usual (psychotropic drugs, psychological and environmental interventions) or 14 days of virtual darkness therapy, that is, exposure to light deprived of blue wavelengths from 19.00-08.00, provided in a secluded patient unit with circadian lightening. Primary outcome is 14 days change in agitation assessed with Cohen-Mansfield Agitation Inventory. Secondary outcomes are change in diurnal variation of motor activity assessed with a smartwatch and sleep monitor, other BPSD, activities of daily living, quality of life, use of psychotropic drugs, use of restraints and coercion, length of hospital stay and resource utilization.\n\nThe investigators will conduct focus group interviews with managers and staff in nursing homes to explore barriers, enablers and adaptions to support implementation of the new methods in municipal dementia care",[72],"Agitation in Dementia, Including Alzheimer's Disease",[74,75,76,77],"virtual darkness theraphy","agitation in dementia","randomized controlled trial","gerontopsychiatric hospital","2025-04-08",{"date":80,"type":81},"2025-04-11","ACTUAL",{"date":83,"type":81},"2024-09-30",{"date":85,"type":66},"2026-12-31",{"name":5,"class":6},1]