Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• Diagnosis of bipolar disorder
• YMRS-score \>13
• Age 18-60 years
• Speaks and writes Danish at a level equal to mother tongue
Locations
Other Locations
Denmark
Psychiatric Center Copenhagen
RECRUITING
Copenhagen
Contact Information
Primary
Helle Madsen, MD
helle.oestergaard.madsen@regionh.dk
38 64 70 81
Time Frame
Start Date: 2024-04-05
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 150
Treatments
Experimental: Blue blocking glasses (BB)
Eyewear with orange-tinted lenses that block 99% of short wavelength visible light \< 500 nm
Sham_comparator: Low filtration glasses (LF)
Eyewear with clear lenses that block 15% of short wavelength light \< 500 nm
Related Therapeutic Areas
Sponsors
Leads: Mental Health Services in the Capital Region, Denmark