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RECRUITINGINTERVENTIONAL

Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of bipolar disorder - YMRS-score \>13 - Age 18-60 years - Speaks and writes Danish at a level equal to mother tongue Who Should NOT Join This Trial: - Not willing or able to adhere to the protocol - Severe eye disorder or eye trauma - Treatment with betablockers - Sleep disturbances not related to BD (e.g, sleep apnea, restless legs syndrome) • • Substance abuse - Unwilling to use the electronic self-monitoring system, the Monsenso system - Prior/current use of BB glasses - Current/planned pregnancy - Night shift work - Suicidality Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Diagnosis of bipolar disorder * YMRS-score \>13 * Age 18-60 years * Speaks and writes Danish at a level equal to mother tongue Exclusion Criteria: * Not willing or able to adhere to the protocol * Severe eye disorder or eye trauma * Treatment with betablockers * Sleep disturbances not related to BD (e.g, sleep apnea, restless legs syndrome) • • Substance abuse * Unwilling to use the electronic self-monitoring system, the Monsenso system * Prior/current use of BB glasses * Current/planned pregnancy * Night shift work * Suicidality

Treatments Being Tested

DEVICE

Blue blocking eyewear

Eyewear is worn daily from 6 PM to 8 AM during manic/hypomanic state Eyewear is worn daily 2 hours before planned bedtime during euthymic, depressive and mixed state

DEVICE

Low filtration eyewear

Eyewear is worn daily from 6 PM to 8 AM during manic/hypomanic state Eyewear is worn daily 2 hours before planned bedtime during euthymic, depressive and mixed state

Locations (1)

Psychiatric Center Copenhagen
Copenhagen, Denmark