NCT05206747Completed
Ottawa Sunglasses at Night for Mania Study
A Randomized Control Trial of the Effectiveness of Blue-blocking Glasses for Mania in Inpatients With Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 17 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 7 Jan 2022
- Start date
- 7 Sept 2022
- Primary completion date
- 6 Sept 2024
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- Bipolar disorder
- NCT number
- NCT05206747
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 7 Sept 2022 to the primary completion date, 6 Sept 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have severe eye disease or trauma
- Have a history of traumatic brain injury.
Other
- Have sleep apnea
- (Sub-study only): Have current exogenous melatonin intake
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| L'Hôpital Montfort Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Ottawa Hospital Research Insitute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
Related publications
- The Ottawa sunglasses at night study: A randomized controlled trial of blue-blocking glasses for mania.J Affect Disord · 2026 · PMID 41421618
This page is information, not medical advice. Discuss any trial with your doctor.