Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder
NCT ID: NCT06271304
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-04-05
2026-06-01
Brief Summary
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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).
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Detailed Description
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The active intervention is BB-glasses that eliminate 99 % of light with a wavelength below 530 nm, whereas the clear glasses filter out only 15% of short wavelength light (low filtration (LF).
Participation includes 3 months use of the designated eyewear along with daily electronic self-monitoring of mood, sleep and activity as well as participation in a 2-day baseline assessment and a total of 3 follow-up visits including clinical assessment interview, questionnaires, and actigraphic (48 hours) and pupillometric assessments at day 9, week 5 and week 15.
Participants will be included during hypomanic or manic state and begin treatment with an antimanic dosage of 14 hours (6 PM - 8 AM) for 7 consecutive days. Subsequently, during the 3-month follow-up period, the dosage (hours using the glasses) can be adjusted according to the current state, with use for 14 hours during hypomanic/manic phases and 2 hours before bedtime during euthymic and depressive states.
Outcome assessors will be blinded to the treatment assignment and patients will be informed that they are randomized to eyewear with either high or low filtration of light. Patients will be randomized on a 1:1 basis with stratification according to sex and outpatient clinic.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Blue blocking glasses (BB)
Eyewear with orange-tinted lenses that block 99% of short wavelength visible light \< 500 nm
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
Low filtration glasses (LF)
Eyewear with clear lenses that block 15% of short wavelength light \< 500 nm
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* YMRS-score \>13
* Age 18-60 years
* Speaks and writes Danish at a level equal to mother tongue
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Mental Health Services in the Capital Region, Denmark
OTHER
Responsible Party
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Principal Investigators
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Lars Kessing
Role: PRINCIPAL_INVESTIGATOR
Mental Health Center Copenhagen
Locations
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Psychiatric Center Copenhagen
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BLUES
Identifier Type: -
Identifier Source: org_study_id
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