Virtual Darkness Theraphy for Agitation in Dementia

Agitation in Dementia, Including Alzheimer's Disease Clinical Trial

— DARKDEM  

Official title:

Virtual Darkness and Digital Phenotyping in Specialized and Municipal Dementia Care: The DARK.DEM Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451952
• Other study ID #: NFR sponsor code 334750
• Secondary ID: 697405
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: University of Bergen
• Contact: Line Iden Berge, M.D., PhD.
• Phone: +4798857354
• Email: line.berge[@]uib.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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

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 data from Empatica Embrace plus wristband 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 Empatica Embrace wristband, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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 beta-blockers and/or melatonin

• Clinically significant pain (MOBID-2=3)

Related Conditions & MeSH terms

• Agitation in Dementia, Including Alzheimer's Disease
• Alzheimer Disease
• Dementia
• Psychomotor Agitation

Intervention

Other:
• Virtual darkness
Chronotheraphy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	NKS Olaviken Gerontopsychiatric Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	To be completed after day 14 of the intervention but before the date of discharge assessed up to 1 year
Primary	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	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 7
Secondary	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	Change from baseline to day 7, change from baseline to day 14
Secondary	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.	Change from baseline to day 7, change from baseline to day 14
Secondary	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	Change from baseline to day 7, change from baseline to day 14
Secondary	Confusion Assessment Method (CAM)	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.	Change from baseline to day 7, change from baseline to day 14
Secondary	Quality of life in dementia (QUALIDEM)	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.	Change from baseline to day 7, change from baseline to day 14
Secondary	Clinical Global Impression scale, CGI	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)	Change from baseline to day 7, change from baseline to day 14
Secondary	Personal activities of daily living, P-ADL	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	Change from baseline to day 7, change from baseline to day 14
Secondary	Direct care time	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)	Change from baseline to day 7, change from baseline to day 14
Secondary	Use of drugs, 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 numbers, use regularly	Change from baseline to day 7, change from baseline to day 14
Secondary	Use of drugs, 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 daily doses, use regularly	Change from baseline to day 7, change from baseline to day 14
Secondary	Use of drugs, 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 numbers, use on demand	Change from baseline to day 7, change from baseline to day 14
Secondary	Use of drugs, doses, 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	Change from baseline to day 7, change from baseline to day 14
Secondary	Decisions on coercion according the The Mental Health Act	Number of decisions	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
Secondary	Decisions on coercion according the The Mental Health Act	Type of decisions	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
Secondary	Living situation	Living situation at discharge categorized in at home- alone, at home- not alone, institution- temporary and institution- permanently	Change from baseline to until the date of discharge assessed up to 1 year
Secondary	Length of hospital stay	Length of hospital stay in days assessed from baseline to date of discharge.	Change from baseline to until the date of discharge assessed up to 1 year
Secondary	Digital biomarker for agitation in dementia	Estimation of agitation in people with dementia resulting from digital measurements collected with the Empatica Embrace Plus wristband. 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).	Change from baseline to day 7, change from baseline to day 14
Secondary	Digital biomarker for depression in dementia	Estimation of depression in people with dementia resulting from digital measurements collected with the Empatica Embrace Plus wristband. 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).	Change from baseline to day 7, change from baseline to day 14
Secondary	Digital biomarker for sleep in dementia	Estimation of sleep in people with dementia resulting from digital measurements collected with the Empatica Embrace Plus wristband. 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).	Change from baseline to day 7, change from baseline to day 14
Secondary	Digital biomarker for circadian rhythm in dementia	Estimation of circadian rhythm parameters in people with dementia resulting from digital measurements collected with the Empatica Embrace Plus wristband. The parameters are represented as a tuple of characteristics that together define the circadian rhythm.	Change from baseline to day 7, change from baseline to day 14
Secondary	Treatment emergent adverse events	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	Change from baseline to day 7, change from baseline to day 14