Virtual Darkness Theraphy for Agitation in Dementia

NCT ID: NCT06451952

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-12-31

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 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

Detailed Description

Successful treatment of BPSD relies on precise assessment. The gold standard is self-report of symptoms, supplemented by proxy rating from relatives and staff. This can be aided by various psychometric scales, such as the Cornell Scale for Depression, Cohen-Mansfield Agitation Inventory and Neuropsychiatric Inventory. However, these scales have weaknesses, they span short time periods, have moderate interrater and test-retest reliability. In particular in the outpatient setting, this hampers the reliability and validity of patients and caregivers reports, and thereby infers the accuracy of the clinicians assessment. A possible enhancement of assessment can be achieved through "digital phenotyping", that is characterization of human behavior by moment-by-moment monitoring with personal digital devices.

First line treatment of BPSD is environmental approaches, which often is resource demanding as it requires extensive staffing. Second line treatment is use of psychotropic drugs, however, effect is modest and come with high risk of interactions and side effects, particularly harmful in fragile older adults. A possible enhancement of BPSD treatment lies in interventions targeting the circadian rhythm. The circadian rhythm is weakened in persons with dementia, and this can potentiate BPSDs. Several trials have demonstrated some effect of bright light therapy on BPSD, however, it has been suggested that the effect is limited due to lack of sufficient light reaching the retina due to eye conditions in the elderly. Therefore, a more useful approach in this population might be virtual darkness, that is blue wavelength depleted evening light.

The DARK.DEM trials primary objective is to develop and evaluate digital phenotyping and virtual darkness therapy to enhance management of BPSD in municipal and specialized dementia care.

Secondary objectives are:

• Determine the feasibility of symptom assessment with wearable sensor technology in patients with dementia admitted to a gerontopsychiatric hospital ward.
• Determine the convergent validity of data obtained via sensor technology in patients with dementia against psychometric scales for assessment of BPSD.
• Determine the effectiveness, feasibility and safety of virtual darkness in the evening and night as adjunctive treatment of agitation in patients with dementia in a gerontopsychiatric hospital ward.
• Explore barriers, enablers and possible adaptions to support implementation of digital phenotyping and virtual darkness therapy in nursing homes.

The investigators will apply a multidisciplinary approach with methods from computer science, hermeneutics and medicine in three work packages (WP).

WP1: DIG.DEM will determine the convergent validity of sensor data against established psychometric scales for BPSD in patients admitted to NKS Olaviken gerontopsychiatric hospital. The investigators will use correlation analyses and knowledge based AI to develop novel digital biomarkers for BPSD.

WP2: DARK.DEM is 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. Inclusion criteria is patients with dementia admitted to the hospital, both genders, above 50 years and CMAI score equal or above 45 points, exclusion criteria is total blindness/diminished bilateral red reflex, use of beta-blockers and/or melatonin, and clinically significant pain (MOBID-2 score equal or above 3 points). 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 sensor data, 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.

WP3: DECIDE.DEM 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. The investigators will use a mixed methods explanatory sequential design, hermeneutical methodology.

Conditions

Agitation in Dementia, Including Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual darkness

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.

Group Type: EXPERIMENTAL

Virtual darkness

Intervention Type: OTHER

Chronotheraphy

Control condition

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual darkness

Chronotheraphy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients admitted to NKS Olaviken gerontopsychiatric hospital
• Diagnosis of dementia, all stages and etiologies,
• ≥50 years
• both genders
• Clinically significant agitation (CMAI ≥45)

Exclusion Criteria

• Total blindness/diminished bilateral red reflex.
• Use of melatonin
• Clinically significant pain (MOBID-2≥3)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NKS Olaviken Gerontopsychiatric Hospital

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NKS Olaviken Gerontopsychiatric Hospital

Askøy, Erdal, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Line Iden Berge, M.D., PhD.

Role: CONTACT

line.berge@uib.no

+4798857354 ext. +47

Sunniva Vibe Skagen, M. Psychol

Role: CONTACT

sunniva.skagen@uib.no

+47 94154315 ext. +47

Facility Contacts

Line I Berge, Ph.D.

Role: primary

Line.berge@uib.no

98857354

Sunniva Vibe Skagen, Cand.Psychol

Role: backup

sunniva.skagen@uib.no

Other Identifiers

697405

Identifier Type: OTHER

Identifier Source: secondary_id

NFR sponsor code 334750

Identifier Type: -

Identifier Source: org_study_id