Clinical trial NCT06451952: Virtual Darkness Theraphy for Agitation in Dementia
Official title: Virtual Darkness and Digital Phenotyping in Specialized and Municipal Dementia Care: The DARK.DEM Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Agitation in Dementia, Including Alzheimer's Disease
Keywords: virtual darkness theraphy
agitation in dementia
randomized controlled trial
gerontopsychiatric hospital
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: NKS Olaviken Gerontopsychiatric Hospital
First posted: 2024-06-11
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: Change from baseline to day 14
Secondary outcomes:
measure: Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: Change from baseline to day 7
measure: Nevropsychiatric Inventory Nursing Home Version NPI-NH
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Cornell Scale for Depression in Dementia (CSDD)
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Sleep Disorder Inventory (SDI)
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Confusion Assessment Method (CAM)
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Quality of life in dementia (QUALIDEM)
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Clinical Global Impression scale, CGI
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Personal activities of daily living, P-ADL
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Direct care time
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Use of drugs, numbers, use regularly
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Use of drugs, doses, use regularly
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Use of drugs, numbers, use on demand
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Use of drugs, doses, use on demand
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Decisions on coercion according the The Mental Health Act
timeFrame: Change from baseline to day 7, change from baseline to day 14, change baseline to until the date of discharge assessed up to 1 year
measure: Decisions on coercion according the The Mental Health Act
timeFrame: Change from baseline to day 7, change from baseline to day 14, change from baseline to until the date of discharge assessed up to 1 year
measure: Living situation
timeFrame: Change from baseline to until the date of discharge assessed up to 1 year
measure: Length of hospital stay
timeFrame: Change from baseline to until the date of discharge assessed up to 1 year
measure: Digital biomarker for agitation in dementia
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Digital biomarker for depression in dementia
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Digital biomarker for sleep in dementia
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Digital biomarker for circadian rhythm in dementia
timeFrame: Change from baseline to day 7, change from baseline to day 14
measure: Treatment emergent adverse events
timeFrame: Change from baseline to day 7, change from baseline to day 14
Other outcomes:
measure: Patient perspective (intervention group)
timeFrame: To be completed after day 14 of the intervention but before the date of discharge assessed up to 1 year
Locations:
city: Askøy
country: Norway
facility: NKS Olaviken Gerontopsychiatric Hospital
state: Erdal
Study officials:
References: