Dim Blue-Free Light Therapy for Agitation in People With Dementia
Tests evening light without blue wavelengths for agitation in adults with dementia.
Plain-language title generated from the registry record
Registry title: Virtual Darkness Theraphy for Agitation in Dementia
Key facts
- Where
- Askøy, NorwaySee the site
Where in Norway
- NKS Olaviken Gerontopsychiatric HospitalAskøy, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Bergen
- Trial code
- NCT06451952
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
Virtual Darkness and Digital Phenotyping in Specialized and Municipal Dementia Care: The DARK.DEM Randomized Controlled Trial
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
Inclusion: Patients refered to NKS Olaviken gerontopsychiatric hospital, both in and outpatient services; Diagnosis of dementia, all stages and etiologies,; ≥50 years; both genders; Clinically significant agitation (CMAI ≥45).
Exclusion: Total blindness/diminished bilateral red reflex; Use of melatonin; Clinically significant pain (MOBID-2≥3).