Using virtual darkness to reduce agitation in dementia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients refered to NKS Olaviken gerontopsychiatric hospital, both in and outpatient services
* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.