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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
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

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
L'Hôpital Montfort
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Ottawa Hospital Research Insitute
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.