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Search / Trial NCT06451952

Virtual Darkness Theraphy for Agitation in Dementia

Launched by UNIVERSITY OF BERGEN · Jun 4, 2024

Trial Information

Current as of June 28, 2025

Recruiting

Keywords

Virtual Darkness Theraphy Agitation In Dementia Randomized Controlled Trial Gerontopsychiatric Hospital

ClinConnect Summary

The DARK.DEM trial is investigating a new treatment called virtual darkness therapy for managing agitation in patients with dementia, including Alzheimer’s disease. Agitation is a common and challenging symptom that can make daily life difficult for both patients and their families. The trial aims to see if exposing patients to a special type of light, which avoids blue wavelengths during the evening and night, can help reduce agitation. Researchers will compare this therapy to standard treatments in a group of at least 72 patients at a gerontopsychiatric hospital.

To participate in the trial, individuals need to be at least 50 years old, diagnosed with dementia, and experiencing significant agitation. However, those who are totally blind or have certain health conditions will not be eligible. Participants can expect to be randomly assigned to either the virtual darkness therapy or the usual care for 14 days. Throughout the trial, researchers will monitor changes in agitation and other related factors, such as daily activities and overall quality of life. This study also plans to gather feedback from nursing home staff to help understand how to make this new treatment approach work well in regular care settings.

Gender

ALL

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)

About University Of Bergen

The University of Bergen is a renowned academic institution located in Norway, recognized for its commitment to advancing medical research and education. With a focus on interdisciplinary collaboration, the university engages in innovative clinical trials that aim to improve patient outcomes and enhance healthcare practices. Leveraging its diverse expertise and state-of-the-art facilities, the University of Bergen fosters a dynamic research environment that attracts both national and international partners, ensuring the translation of scientific discoveries into effective clinical applications. The institution is dedicated to maintaining the highest ethical standards and regulatory compliance in all its research endeavors.

Locations

Askøy, Erdal, Norway

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported