An interventional study of Blue blocking eyewear and Low filtration eyewear in Bipolar Disorder, sponsored by Mental Health Services in the Capital Region, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Mental Health Services in the Capital Region, Denmark · Not applicable, Interventional, and Treatment
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).
The study is a 2-arm single-blind RCT to assess the effects of blue blocking (BB) or clear glasses as an acute 7-day antimanic intervention and as a 3-month mood stabilizing maintenance intervention. BB or clear glasses will be applied in addition to outpatient TAU for BD. Participants will be recruited among patients treated for BD in specialized outpatient clinics within the Mental Health Center Copenhagen.
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 150 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Mental Health Services in the Capital Region, Denmark is the lead sponsor of 49 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Eyewear with orange-tinted lenses that block 99% of short wavelength visible light \< 500 nm
Device: Blue blocking eyewear
Eyewear with clear lenses that block 15% of short wavelength light \< 500 nm
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
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
Manic symptoms
Change in Young Mania Rating Scale Score, range 0-60, higher scores indicating greater manic symptom load
Time frame: 7 days
Mood instability
Change in day-to-day variation in electronically self-monitored mood scores
Time frame: 15 weeks
Objective sleep quality
Actigraphic measures of sleep latency, sleep time, efficiency and wake periods
Time frame: 7 days
Objective sleep quality
Actigraphic measures of sleep latency, sleep time, efficiency and wake periods
Time frame: 15 weeks
Subjective sleep quality
change in sleep scores from a modified version of the Pittsburgh Sleep Quality Index, range 0-21, higher scores indicating worse sleep quality
Time frame: 7 days
Subjective sleep quality
change in sleep scores from a modified version of the Pittsburgh Sleep Quality Index, range 0-21, higher scores indicating worse sleep quality
Time frame: 15 weeks
Plan to share: No
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Mental Health Services in the Capital Region, Denmark