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Life sciences · Interventional Study
ClinicalTrials.gov · October 21, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06451952). This is a study registration, not published results. Lead sponsor: University of Bergen. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 72 participants (ESTIMATED). Conditions: Agitation in Dementia, Including Alzheimer's Disease. Interventions: OTHER: Virtual darkness. Primary outcome measures: Cohen-Mansfield Agitation Inventory (CMAI) , Change from baseline to day 14. Brief summary: 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. The DARK.DEM trial aims at developing new diagnostics and treatment for BPSD in both specialized and municipal dementia care. The investigators will develop digital phenotyping by determining the convergent validity of data from a smartwatch against established psychometric scales for BPSD for patients referred to NKS Olaviken gerontopsychiatric hospital. The 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 referred to the hospital, either as inpatients or outpatients. 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 or with blue-blocking glasses. 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. The 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