NCT06271304Not yet recruiting

Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

Name: Clinical Trial NCT06271304
Creator: Mental Health Services in the Capital Region, Denmark
Keywords: Bipolar Disorder, Blue blocking eyewear, device, clinical trial

Mental Health Services in the Capital Region, DenmarkClinicalTrials.govdeviceDevice trial

Verified

Study focus

Disease/Condition: Bipolar Disorder
Drug/Device/Intervention: Blue blocking eyewear
Study type: Interventional
Intervention type: device

Sponsor & location

Primary sponsor: Mental Health Services in the Capital Region, Denmark

Timeline & enrollment

Phase: N/A
Start date: Mar 01, 2024
End date: Jun 01, 2026
Enrollment: 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 disorderBipolar affective disorder, unspecifiedOther bipolar affective disordersBipolar affective disorder, currently in remissionBipolar affective disorder, current episode mixed

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06271304
Type: Device Trial

About this record

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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