Virtual Darkness Theraphy for Agitation in Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Bergen
About this 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 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 criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to NKS Olaviken gerontopsychiatric hospital
Diagnosis of dementia, all stages and etiologies,
≥50 years
both genders
Disqualifiers
Total blindness/diminished bilateral red reflex.
Use of melatonin
Clinically significant pain (MOBID-2≥3)
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual darkness
Other interventionChronotheraphy
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Virtual darknessExperimental treatment 1 intervention
Group B: Control conditionNo intervention 0 interventions
Trial outcomes
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.
Time frame
Change from baseline to day 14Secondary 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.
Time frame
Change from baseline to day 72
Nevropsychiatric Inventory Nursing Home Version NPI-NH
Neuropsychiatric symptoms assessed with the Norwegian version of the Neuropsychiatric Inventory Nursing Home Version (NPI-NH): Instrument for proxy rating of neuropsychiatric symptoms in people with dementia over the past 4 weeks. A total of 12 items symptoms and behaviors are assessed regarding frequency (0: not present, 4: very frequent), severity (0: mild, 3: severe) and burden for caregivers (0: no burden, 5: severe burden), total score range 0-144, high score indicates frequent, severe and burdensome symptoms. The Norwegian version of NPH-NH has good validity and reliability
Time frame
Change from baseline to day 7, change from baseline to day 143
Cornell Scale for Depression in Dementia (CSDD)
Depressive symptoms assessed with Cornell Scale for Depression in Dementia (CSDD). This is an instrument for proxy rating of depressive symptoms in dementia over the past week. It has high inter-rater reliability, validity and sensitivity to change. A total of 19 symptoms are evaluated from 0= no symptoms to 2= severe symptoms. Total score range 0-38 points, score ≥8 indicates depression, score ≥ 12 indicates severe depression.
Time frame
Change from baseline to day 7, change from baseline to day 144
Sleep Disorder Inventory (SDI)
This instrument is an extended version of the one sleep item of the Neuropsychiatric Inventory (NPI) and proxy-rates sleep over the past 2 weeks. A total of 8 sleep behaviors are assessed regarding frequency (0: not present, 4: very frequent), severity (0: mild, 3: severe) and burden for caregivers (0: no burden, 5: severe burden), total score range 0-96, high score indicates frequent, severe and burdensome symptoms. In DARK.DEM, SDI will be used to evaluate sleep over the past 7 days
Time frame
Change from baseline to day 7, change from baseline to day 14Other outcomes
1
Patient perspective (intervention group)
Patient perspective: There is a lack in the literature on assessment tools to systematically evaluate a person with dementias perspective on treatment. Therefore, 3-5 questions will be developed to be evaluated by the person with dementia together with the responsible physician /psychologist after the intervention period (day 14). This could for example be: Have the participant noticed that it has received exposure to orange light during evening and night as supplemental treatment? (yes/no/partly) How did the participant perceive this light? (comfortable/uncomfortable/neutral/no opinion). How the participant perceive wearing a smartwatch? (invasive/not invasive/no opinion). This form will also have a blank space for quotations.
Time frame
To be completed after day 14 of the intervention but before the date of discharge assessed up to 1 yearLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
NKS Olaviken Gerontopsychiatric HospitalRecruiting5306, Askøy, Erdal
Norway
NorwaySponsors and contacts
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University of Bergen
Lead sponsor
NKS Olaviken Gerontopsychiatric Hospital
Collaborator
Source ClinicalTrials.gov