Ottawa Sunglasses at Night for Mania Study

NCT ID: NCT05206747

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-07
• Study Completion Date: 2024-09-09

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.

Detailed Description

The purpose of this research project is to determine the effectiveness of blue-blocking glasses as adjunctive treatment for mania in bipolar disorder, assess circadian mechanisms, and provide information to improve translation to real-world practice settings. The investigators propose to conduct a confirmatory and more definitive clinical trial of blue-blocking glasses for mania and explore the putative role of circadian factors in mechanisms of action.

The primary objective is to specifically determine whether blue-blocking glasses are effective at reducing manic symptoms in inpatients beyond any general reduction in light exposure. This represents an advance on prior study, which compared them to clear lenses. For reasons outlined in the background, the investigators hypothesis that adding blue-blocking glasses to pharmacological treatment as usual for mania will improve symptoms, as measured by the clinician administered rating scales.

The secondary objectives relate to understanding how the reduction in manic symptoms with blue blocking glasses corresponds to changes in circadian rhythms. Not all patient with mania will be able to participate in this portion of the protocol (relevant to Aim 2 below) and it will subsequently be performed in a subset of patients, who are both capable and interested in adhering to the protocol, and at sites able to implement. At this time, the investigators anticipate this portion of the protocol being administered at the two campuses of The Ottawa Hospital. The investigators hypothesize that changes in circadian rhythms will be correlated to improvement in manic symptoms and thus a likely mechanisms of action.

The investigators also plan to conduct qualitative interviews to inform future implementation of this or related interventions (Aim 3).

Aim 1 (Effectiveness): To compare the effectiveness (change in Young Mania Rating Scale) of blue-blocking glasses to lightly tinted glasses as an adjunctive therapy with treatment as usual for psychiatric inpatients with mania.

Aim 2 (Support of Mechanism): To assess whether the reduction in manic symptoms with blue blocking glasses relates to the degree of changes in circadian rhythms (based on melatonin release curves, body temperature, heart rate, and the rest-activity cycle derived from actigraphy) and sleep (subjective and based on actigraphy).

Aim 3 (Translation to Practice): To improve translation to real-world practice settings, qualitative interviews with staff and patients will be performed using the Reach Effectiveness Adoption Implementation (RE-AIM) model.

Conditions

Mania; Sleep; Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Blue-blocking glasses

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.

Group Type: EXPERIMENTAL

Blue-blocking glasses

Intervention Type: DEVICE

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

Lightly-tinted glasses

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.

Group Type: SHAM_COMPARATOR

Lightly-tinted glasses

Intervention Type: 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.

Interventions

Blue-blocking glasses

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

Intervention Type: DEVICE

Lightly-tinted glasses

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jess G Fiedorowicz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Ottawa Hospital Research Insitute

Ottawa, Ontario, Canada

L'Hôpital Montfort

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20210790-01H

Identifier Type: -

Identifier Source: org_study_id