Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder (BLUES)

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).

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder
• Intervention / Treatment: Device: Blue blocking eyewear; Device: Low filtration eyewear

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helle Madsen, MD; Phone Number: 38 64 70 81; Email: helle.oestergaard.madsen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Psychiatric Center Copenhagen
    • Contact: Maria Faurholt-Jepsen, MD, DMSc; Phone Number: 0045 38647073; Email: maria.faurholtjepsen@regionh.dk
    • Contact: Lars V Kessing, Professor; Phone Number: 0045 38647081; Email: lars.vedel.kessing@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blue blocking glasses (BB); Eyewear with orange-tinted lenses that block 99% of short wavelength visible light < 500 nm	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
Sham Comparator: Low filtration glasses (LF); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manic symptoms	Change in Young Mania Rating Scale Score, range 0-60, higher scores indicating greater manic symptom load	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood instability	Change in day-to-day variation in electronically self-monitored mood scores	15 weeks
Objective sleep quality	Actigraphic measures of sleep latency, sleep time, efficiency and wake periods	7 days
Objective sleep quality	Actigraphic measures of sleep latency, sleep time, efficiency and wake periods	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	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	15 weeks

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Investigators: Principal Investigator: Lars Kessing, Mental Health Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: BLUES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No