Virtual Darkness Therapy and Digital Monitoring to Improve Agitation in Dementia Patients Aged 50 and Older

What this Trial Is About

Behavioral and psychological symptoms of dementia BPSD such as anxiety, depression, psychosis, and agitation are common, often hard to treat, and greatly affect cognition, independence, quality of life, and survival in people with dementia. The DARK.DEM trial seeks to improve diagnosis and treatment of BPSD in both specialized hospital and community dementia care. It focuses on developing digital phenotyping using smartwatch data and evaluating virtual darkness therapy as an additional treatment for agitation. The trial includes an open-label randomized controlled study with at least 72 patients admitted to a gerontopsychiatric hospital. Participants are randomly assigned to either usual treatmentcomprising psychotropic drugs, psychological and environmental interventionsor 14 days of virtual darkness therapy. This therapy involves exposure to light without blue wavelengths from 7 PM to 8 AM in a specially designed patient unit with circadian lighting. Patients able to wear blue-blocking glasses may stay outside the unit during these hours. The study also includes focus groups with nursing home staff to explore how these new methods could be implemented in community care. Participants will be monitored over 14 days, with assessments including agitation measured by the Cohen-Mansfield Agitation Inventory, motor activity via smartwatch and sleep monitors, other BPSD symptoms, daily living activities, quality of life, psychotropic drug use, restraints, hospital stay length, and resource use. The study gathers data through psychometric scales and wearable sensors to evaluate effectiveness, feasibility, and safety of the interventions. The overall aim is to enhance management of agitation and other BPSD in dementia care settings.

Virtual Darkness Theraphy for Agitation in Dementia