Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

Bipolar Disorder Clinical Trial

— BLUES  

Official title:

Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06271304
• Other study ID #: BLUES
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Helle Madsen, MD
• Phone: 38 64 70 81
• Email: helle.oestergaard.madsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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
• 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

Country	Name	City	State
Denmark	Psychiatric Center Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manic symptoms	Change in Young Mania Rating Scale Score, range 0-60, higher scores indicating greater manic symptom load	7 days
Secondary	Mood instability	Change in day-to-day variation in electronically self-monitored mood scores	15 weeks
Secondary	Objective sleep quality	Actigraphic measures of sleep latency, sleep time, efficiency and wake periods	7 days
Secondary	Objective sleep quality	Actigraphic measures of sleep latency, sleep time, efficiency and wake periods	15 weeks
Secondary	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	7 days
Secondary	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	15 weeks