Virtual Darkness Theraphy for Agitation in Dementia

NCT06451952 | Recruiting DMC

• 2 other identifiers: NFR sponsor code 334750697405
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Agitation in Dementia, Including Alzheimer's Disease

Keywords

virtual darkness theraphy; agitation in dementia; randomized controlled trial; gerontopsychiatric hospital

Outcome Measures

Primary Outcomes (1)

• Cohen-Mansfield Agitation Inventory (CMAI)

  The CMAI is a clinically validated agitation rating scale that measures the frequency of 29 items on agitated behaviors, encompassing four clusters of behavior: 1) aggressive behavior (e.g. hitting, kicking, screaming), 2) physically non-aggressive behavior (e.g. pacing, trying to get to a different place, restlessness), 3) verbally agitated behavior (complaining, constant requests for attention, repetitive questions) and 4) hiding and hoarding. Each of the 29 items are scored from 1 (no) to 7 (severe) evaluating the past 14 days. Scale range from 29-203, high score indicates severe symptoms. The CMAI correlates with other neuropsychiatric symptom scales, has high internal consistency and adequate inter-rater reliability with regard to physical aggression and verbal agitation.

  Change from baseline to day 14

Secondary Outcomes (22)

• Cohen-Mansfield Agitation Inventory (CMAI)

  Change from baseline to day 7

• Nevropsychiatric Inventory Nursing Home Version NPI-NH

  Change from baseline to day 7, change from baseline to day 14

• Cornell Scale for Depression in Dementia (CSDD)

  Change from baseline to day 7, change from baseline to day 14

• Sleep Disorder Inventory (SDI)

  Change from baseline to day 7, change from baseline to day 14

• Confusion Assessment Method (CAM)

  Change from baseline to day 7, change from baseline to day 14

Other Outcomes (1)

• Patient perspective (intervention group)

  To be completed after day 14 of the intervention but before the date of discharge assessed up to 1 year

Study Arms (2)

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.

Other: Virtual darkness

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

Interventions

Virtual darkness OTHER

Chronotheraphy

Virtual darkness

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bergen: lead
• NKS Olaviken Gerontopsychiatric Hospital: collaborator

Study Sites (1)

NKS Olaviken Gerontopsychiatric Hospital

Askøy, Erdal, 5306, Norway

RECRUITING

MeSH Terms

Conditions

Aberrant Motor Behavior in Dementia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Line Iden Berge, M.D., PhD.

CONTACT

+4798857354; line.berge@uib.no

Sunniva Vibe Skagen, M. Psychol

CONTACT

+47 94154315; sunniva.skagen@uib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, single blinded randomized controlled trial, parallel arm, allocation ratio 1:1, to evaluate the superiority of virtual darkness as add on to treatment as usual.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: June 11, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: IPD will be shared with other researchers upon reasonable request to the principal investigator.

Locations

NO (1)