Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

Not Applicable

Recruiting

• Conditions: Bipolar Disorder
• Interventions: Device: Low filtration eyewear; Device: Blue blocking eyewear

• Registration Number: NCT06271304
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

Brief 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).

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 Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-21
• Study Start: 2024-04-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low filtration glasses (LF)	Low filtration eyewear	Eyewear with clear lenses that block 15% of short wavelength light \< 500 nm
Blue blocking glasses (BB)	Blue blocking eyewear	Eyewear with orange-tinted lenses that block 99% of short wavelength visible light \< 500 nm

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mood instability	15 weeks	Change in day-to-day variation in electronically self-monitored mood scores
Objective sleep quality	15 weeks	Actigraphic measures of sleep latency, sleep time, efficiency and wake periods
Subjective sleep quality	15 weeks	change in sleep scores from a modified version of the Pittsburgh Sleep Quality Index, range 0-21, higher scores indicating worse sleep quality

Trial Locations

Locations (1)

Psychiatric Center Copenhagen; 🇩🇰 Copenhagen, Denmark