Ottawa Sunglasses at Night for Mania Study

NCT05206747 | Completed DMC

• 1 other identifier: 20210790-01H
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Mania is a serious condition. Symptoms of mania include decreased sleep, increased energy, changes in mood, thinking, and behavior. Dark therapy, which involves placing patients in a dark room for 14 hours overnight, can effectively treat mania, but is not practical. Dark therapy is also unpleasant. However, similar effects on the brain can be created from blocking only blue light with glasses. This preserves the wearer's ability to see and move safely. A trial of blue-blocking glasses for mania in Norway produced dramatic improvements in manic symptoms within three days of hospitalization. Mania both disrupts the sleep-wake cycle and is triggered by short and interrupted sleep. Examples of triggers include shift work and travel across time zones. Therefore, mania involves the "day-night" clock in the brain. The rhythm of the brain's clock is set by special sensors in the eye that identify daytime from blue light. If light does not include this blue spectrum, this informs the brain it is nighttime. In spite of the obvious potential of blue blocking glasses for mania, there has been no confirmatory study of this simple treatment in the five years since the initial Norwegian trial. Without a second study, this treatment will not find its way into routine clinical care. The investigators will conduct a randomized controlled trial of blue-blocking glasses for mania in hospitalized patients. The investigators will also assess activity, sleep, and saliva melatonin (a hormone secreted in the brain at night) to see how this treatment works. If our trial confirms that blue-blocking glasses are effective, this treatment could help those suffering with mania return to their life more quickly. Medications for mania can also cause serious side-effects and having glasses as a treatment option might also reduce the amount of medicine needed to get well. Blue-blocking glasses could be a low-cost non-medication treatment. The investigators will look at how they could put this treatment into practice as part of everyday care.

Conditions

Mania; Sleep; Bipolar Disorder

Keywords

Blue Blocking Glasses; Randomized

Outcome Measures

Primary Outcomes (1)

• Change in the Young Mania Rating Scale

  The Young Mania Rating Scale is used to evaluate the severity of manic symptoms at baseline and over time in individuals with mania. It is an 11-item scale and total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). We will model differences between groups in the primary outcome using linear mixed models (group by time interaction) including a random intercept term for participant.

  Baseline to Week 2 (End of Study)

Secondary Outcomes (14)

• Amount of antipsychotic (in chlorpromazine equivalents) and benzodiazepine used (in lorazepam equivalents)

  Baseline to Week Two (End of Study)

• Total number of medications needed

  Baseline to Week Two (End of Study)

• Differences in sleep efficiency as estimated from actigraphy

  Baseline to Two Weeks (End of Study)

• Change in the Patient Mania Questionnaire - 9-Item Scale for Assessing and Monitoring Manic Symptoms (PMQ-9)

  Baseline; Week One; Two Week (End of Study)

• Change in the Digital Self-Report Survey of Mood for Bipolar Disorder - 6-Item Digital Survey Measuring Mood Changes in Bipolar Disorder (digiBP)

  Baseline; Week One; Two Week (End of Study)

Study Arms (2)

Blue-blocking glasses

EXPERIMENTAL

Participants will wear orange/amber colored lenses that filter wavelengths of light in the blue spectrum while awake from 6 p.m. to 8 a.m.

Device: Blue-blocking glasses

Lightly-tinted glasses

SHAM COMPARATOR

This control will involve glasses that selectively filter short wavelength (e.g., ultraviolet), but not visible blue light during the same time window. Participants will wear these glasses while awake from 6 p.m. to 8 a.m.

Device: Lightly-tinted glasses

Interventions

Blue-blocking glasses DEVICE

It will transmit 45% of visible light with the following light transmission profile.

Blue-blocking glasses

Lightly-tinted glasses DEVICE

It will also filter short wavelength light but at a lower threshold with near identical transmission above this threshold. It will transmit 91% of visible light with the following light transmission profile.

Lightly-tinted glasses

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 to 70 years of age
• Have a Diagnostic and Statistical Manual of Mental Disorders (5th Edition) defined manic symptoms that persist beyond the physiological effects of a substance
• Be willing to have investigators obtain information from the treatment team and electronic medical record
• Participants must be able to read and understand English or French.
• Be willing and able to provide informed consent.
• (Sub-study only): Meet the safety specifications for the devices in the sub-study, according to their user manuals

You may not qualify if:

• Have severe eye disease or trauma
• Have a history of traumatic brain injury.
• Have sleep apnea
• (Sub-study only): Have current exogenous melatonin intake

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

Ottawa Hospital Research Insitute

Ottawa, Ontario, K1Y 4E9, Canada

Location

L'Hôpital Montfort

Ottawa, Ontario, Canada

Location

Related Publications (1)

• Fiedorowicz JG, Mikhail E, Solmi M, Burns JK, Yu J, Siddiqi S, Nguyen T, Smith AL, Robillard R; Ottawa Sunglasses at Night Investigators and Coordinators. The Ottawa sunglasses at night study: A randomized controlled trial of blue-blocking glasses for mania. J Affect Disord. 2026 Apr 1;398:120910. doi: 10.1016/j.jad.2025.120910. Epub 2025 Dec 18.

  PMID: 41421618 DERIVED

MeSH Terms

Conditions

Mania; Bipolar Disorder

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Jess G Fiedorowicz, MD, PhD

  Head and Chief, Department of Mental Health, The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be informed that the investigators are studying the effects of two different types of light filters without more detail so they will not know which is the experimental vs. control condition. With possible un-blinding from other sources of information and lens color, the investigators will assess the integrity of the blind by asking participants whether they thought they received the experimental or the control glasses at the end of the study. Participates will also be encouraged not to share details of their glasses assignment with other participants and physicians to avoid unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators plan to conduct an up to two-week single-blind, randomized controlled trial of blue-blocking glasses added to treatment as usual for mania. Participants will be randomized 1:1 to wearing blue blocking glasses or lightly-tinted glasses. To ensure temporal and geographic balance, randomization will be stratified by the three sites in blocks of four.

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 25, 2022
• Study Start: September 7, 2022
• Primary Completion: September 6, 2024
• Study Completion: September 9, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)