Using virtual darkness to reduce agitation in dementia patients
Virtual Darkness and Digital Phenotyping in Specialized and Municipal Dementia Care: The DARK.DEM Randomized Controlled Trial
NA · University of Bergen · NCT06451952
This study is testing if using virtual darkness can help reduce agitation in people with dementia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Bergen (other) |
| Locations | 1 site (Askøy, Erdal) |
| Trial ID | NCT06451952 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of virtual darkness therapy as an adjunctive treatment for agitation in patients with dementia. It aims to develop digital phenotyping by comparing smartwatch data with established psychometric scales for behavioral and psychological symptoms of dementia (BPSD). The study will involve a randomized controlled trial with at least 72 patients, assessing the feasibility and safety of this innovative approach in a gerontopsychiatric hospital setting. The goal is to enhance treatment options for agitation, which is often resistant to conventional therapies.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 and older, diagnosed with dementia of any stage, who exhibit clinically significant agitation.
Not a fit: Patients who are totally blind or have significant pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel, non-pharmacological option to alleviate agitation in dementia patients, improving their quality of life.
How similar studies have performed: While some studies have shown positive effects of light therapy on BPSD, the use of virtual darkness as a treatment approach is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Askøy, Erdal
- NKS Olaviken Gerontopsychiatric Hospital — Askøy, Erdal, Norway (RECRUITING)
Study contacts
- Study coordinator: Line Iden Berge, M.D., PhD.
- Email: line.berge@uib.no
- Phone: +4798857354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Agitation in Dementia, Including Alzheimer's Disease, virtual darkness theraphy, agitation in dementia, randomized controlled trial, gerontopsychiatric hospital