RecruitingNot ApplicableNCT06451952

Virtual Darkness Theraphy for Agitation in Dementia

Virtual Darkness and Digital Phenotyping in Specialized and Municipal Dementia Care: The DARK.DEM Randomized Controlled Trial


Sponsor

University of Bergen

Enrollment

72 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

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 admitted 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 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. 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


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether "virtual darkness therapy" — using special glasses that block blue light to simulate darkness — can reduce agitation and restlessness in people with dementia who are admitted to a psychiatric hospital. Agitation is a very common and distressing symptom of dementia. **You may be eligible if...** - You are 50 years or older and have been diagnosed with dementia (any type or stage) - You are admitted to NKS Olaviken gerontopsychiatric hospital - You are experiencing significant agitation (scored 45 or higher on the CMAI agitation scale) **You may NOT be eligible if...** - You are completely blind or have severely impaired vision in both eyes - You are currently taking melatonin - You are experiencing significant pain (scored 3 or higher on the MOBID-2 pain scale) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERVirtual darkness

Chronotheraphy


Locations(1)

NKS Olaviken Gerontopsychiatric Hospital

Askøy, Erdal, Norway

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06451952