Virtual Darkness Theraphy for Agitation in Dementia

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.

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.

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

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.

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

Delirium assessed with Confusion Assessment Method (CAM) short version. This instrument relies on staff observation to evaluate sudden start and fluctuation of symptoms, inattention, disorganized thoughts and awareness, each of these items are scored 1 if symptoms are present, high score indicated likely delirium. CAM has shown high sensitivity, specificity and inter-rater reliability in identifying delirium in samples with older adults and is also recommended for use in people with dementia.

This instrument proxy rates the quality of life to persons with mild to severe dementia ≥65 years. The instrument structure and content are based on the adaption-coping model and covers nine domains of QoL: care relationship, positive affect, negative affect, restless tense behavior, positive self-image, social relations, social isolation, feeling at home and having something to do. A total of 40 items regarding behavior are evaluated according to frequency the last week (never, seldom, sometimes, often). The instrument has good reliability and validity.

Clinical impression A brief, stand-alone assessment of the clinician's view of the patient's global functioning prior and after an intervention and takes into account all available information, also including knowledge on the patient's history, psychosocial circumstances, symptoms, behavior and the impact of the symptoms on the patient's ability to function. CGI has two components 1) the Severity of illness (CGI-S): Considering the raters total clinical experience with this particular population, how mentally ill is the patient at this time rated on a seven-point scale from 1 (normal)-7 (most extremely ill patients). 2) Clinical Global Impression-Improvement (CGI-I) asks the clinician to compare the patients overall clinical condition to the one-week period to the initiation of the treatment: Compared to the patient's condition at baseline, this patient's condition is rated on a seven-point scale from 1 (very much improved) - 7 (very much worse)

This proxy rated instrument assess the ability to perform six areas of personal ADL, that is toileting, feeding, dressing, grooming, physical ambulation and showering, scale range 6-30, high score indicate worse outcome

Direct care time will be evaluated with assessment of how many hours/24 hours the staff provide care in 1 to 1 ratio, or 2 to 1 ratio (patient:staff ratio)

Drugs in use on day 7 and 14 will assessed from the participants medical journal and classified according to the ATC classification in numbers, use regularly

Drugs in use on day 7 and 14 will assessed from the participants medical journal and classified according to the ATC classification in daily doses, use regularly

Drugs in use on day 7 and 14 will assessed from the participants medical journal and classified according to the ATC classification in numbers, use on demand

Drugs in use on day 7 and 14 will assessed from the participants medical journal and classified according to the ATC classification in daily doses, use on demand

Number of decisions

Type of decisions

Living situation at discharge categorized in at home- alone, at home- not alone, institution- temporary and institution- permanently

Length of hospital stay in days assessed from baseline to date of discharge.

Estimation of agitation in people with dementia resulting from digital measurements collected with the Empatica Embrace Plus wristband and Somnofy. Agitation is represented as a score defined over the interval 0-100, where 0 represents no agitation and 100 represents severe agitation (equivalent to maximum score on CMAI).

Estimation of depression in people with dementia resulting from digital measurements collected with the Empatica Embrace Plus wristband and Somnofy. Depression is represented as a score defined over the interval 0-100, where 0 represents no depression and 100 represents severe depression (equivalent to maximum score on CSDD).

Estimation of sleep in people with dementia resulting from digital measurements collected with the Empatica Embrace Plus wristband and Somnofy. Sleep is represented as a score defined over the interval 0-100, where 0 represents no sleep disturbances and 100 represents severe sleep disturbances (equivalent to maximum score on SDI).

Estimation of circadian rhythm parameters in people with dementia resulting from digital measurements collected with the Empatica Embrace Plus wristband and Somnofy. The parameters are represented as a tuple of characteristics that together define the circadian rhythm.

Treatment Emergent Adverse Events will be evaluated in frequency and severity of headache, dizziness, depressive symptoms, eye strain, eye discomfort, blurred vision, falls, fractures, delirium, and the clinician evaluated causal relationship between the intervention and the serious adverse event (unlikely, possible, probable, definite). In addition, we will count the number of fractures, transference to somatic hospital and deaths

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.