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Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder - Trial NCT06271304

Access comprehensive clinical trial information for NCT06271304 through Pure Global AI's free database. This phase not specified trial is sponsored by Mental Health Services in the Capital Region, Denmark and is currently Not yet recruiting. The study focuses on Bipolar Disorder. Target enrollment is 150 participants.

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Trial Details
ClinicalTrials.gov โ€ข NCT06271304
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Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

Study Focus

Bipolar Disorder

Blue blocking eyewear

Interventional

device

Sponsor & Location

Mental Health Services in the Capital Region, Denmark

Timeline & Enrollment

N/A

Mar 01, 2024

Jun 01, 2026

150 participants

Primary Outcome

Manic symptoms

Summary

The study investigates whether add-on treatment with eyewear that blocks the short
 wavelengths of visible light (500nm) reduces manic symptoms and improves sleep in patients
 receiving outpatient treatment as usual for bipolar disorder.
 
 When in a hypomanic or manic phase, participants will be randomized to receive add-on
 treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7
 days.
 
 After this initial intervention phase, the eyewear is used daily for 3 months in either
 antimanic dose (14 hours) or maintenance dose (2 hours before bedtime).

ICD-10 Classifications

Bipolar affective disorder
Bipolar affective disorder, unspecified
Other bipolar affective disorders
Bipolar affective disorder, currently in remission
Bipolar affective disorder, current episode mixed

Data Source

ClinicalTrials.gov

NCT06271304

Device Trial