Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06271304

Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

Led by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Updated on 2024-05-08

150

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of bipolar disorder
  • Young Mania Rating Scale (YMRS) score greater than 13
  • Age between 18 and 60 years
  • Speaks and writes Danish at a level equal to mother tongue
Not Eligible

You will not qualify if you...

  • Not willing or able to follow the study protocol
  • Severe eye disorder or history of eye trauma
  • Current treatment with beta blockers
  • Sleep problems not related to bipolar disorder (e.g., sleep apnea, restless legs syndrome)
  • Substance abuse
  • Unwillingness to use the electronic self-monitoring system (Monsenso system)
  • Previous or current use of blue blocking glasses
  • Current or planned pregnancy
  • Night shift work
  • Suicidal thoughts or behaviors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Psychiatric Center Copenhagen

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

H

Helle Madsen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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