NCT05206747: OSAN

Ottawa Sunglasses at Night for Mania Study

Completed NA Last updated 17 January 2025

What this trial tests

NA trial testing Blue-blocking glasses in Mania in 42 participants. Completed in 9 September 2024.

Timeline

7 September 2022

Primary endpoint
6 September 2024

9 September 2024

Quick facts

Lead sponsor	Ottawa Hospital Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	42
Start date	7 September 2022
Primary completion	6 September 2024
Estimated completion	9 September 2024
Sites	2 locations across Canada

Drugs / interventions tested

• Blue-blocking glasses
• Lightly-tinted glasses

Conditions studied

• Mania — all drugs for Mania →
• Sleep — all drugs for Sleep →
• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Ottawa Hospital Research Institute

Who can join

Adults 18 to 70, any sex, with Mania or Sleep. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Blue-light filtering spectacle lenses for visual performance, sleep, and macular health in adults.
   Singh S, Keller PR, Busija L, McMillan P, et al · · 2023 · cited 23× · PMID 37593770 · DOI 10.1002/14651858.cd013244.pub2
2. The feasibility of conducting non-pharmacological research studies in participants with mania: a grounded theory qualitative analysis of the Ottawa Sunglasses at Night study.
   Yu J, Burns JK, Mikhail E, Solmi M, et al · · 2025 · cited 1× · PMID 40781930 · DOI 10.1080/17482631.2025.2540795
3. The Ottawa sunglasses at night study: A randomized controlled trial of blue-blocking glasses for mania.
   Fiedorowicz JG, Mikhail E, Solmi M, Burns JK, et al · · 2026 · PMID 41421618 · DOI 10.1016/j.jad.2025.120910
4. Efficacy of blue-light blocking glasses on actigraphic sleep outcomes: a systematic review and meta-analysis of randomized controlled crossover trials.
   Luna-Rangel FA, Gonzalez-Bedolla B, Salazar-Ortega MJ, Torres-Mancilla XM, et al · · 2025 · PMID 41341515 · DOI 10.3389/fneur.2025.1699303