Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

NCT06271304 | Recruiting DMC

• 1 other identifier: BLUES
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Manic symptoms

  Change in Young Mania Rating Scale Score, range 0-60, higher scores indicating greater manic symptom load

  7 days

Secondary Outcomes (5)

• Mood instability

  15 weeks

• Objective sleep quality

  7 days

• Objective sleep quality

  15 weeks

• Subjective sleep quality

  7 days

• Subjective sleep quality

  15 weeks

Study Arms (2)

Blue blocking glasses (BB)

EXPERIMENTAL

Eyewear with orange-tinted lenses that block 99% of short wavelength visible light \< 500 nm

Device: Blue blocking eyewear

Low filtration glasses (LF)

SHAM COMPARATOR

Eyewear with clear lenses that block 15% of short wavelength light \< 500 nm

Device: Low filtration eyewear

Interventions

Blue blocking eyewear DEVICE

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

Blue blocking glasses (BB)

Low filtration eyewear DEVICE

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 glasses (LF)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of bipolar disorder
• YMRS-score \>13
• Age 18-60 years
• Speaks and writes Danish at a level equal to mother tongue

You may not qualify if:

• 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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (1)

Psychiatric Center Copenhagen

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Lars Kessing

  Mental Health Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helle Madsen, MD

CONTACT

38 64 70 81; helle.oestergaard.madsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are instructed not to discuss the appearance of their designated eyewear with their care providers or the investigator or outcome assessor. Participants are not informed of the exact filtration level of their eyewear.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Outcome assessors will be blinded to the treatment assignment. At the beginning of each assessment, participants will be instructed not to describe or discuss their glasses with the assessor. Because the two types of glasses are of different color (clear (LF) and orange (BB)), we cannot guarantee a full blinding of the participants. Participants will be informed that we are studying the effects of two different types of light filters without more detail so they will not be provided with certain knowledge of which condition is expected to yield the largest effect. We will assess the integrity of the blind by asking participants whether they think they received glasses with high or low filtration lenses at the end of the study. Participants will be discouraged from actively seeking information about sleep glasses during the study

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: April 5, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)