Clinical trial NCT05206747: Ottawa Sunglasses at Night for Mania Study
Official title: A Randomized Control Trial of the Effectiveness of Blue-blocking Glasses for Mania in Inpatients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mania
Sleep
Bipolar Disorder
Keywords: Blue Blocking Glasses
Randomized
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the Young Mania Rating Scale
timeFrame: Baseline to Week 2 (End of Study)
Secondary outcomes:
measure: Amount of antipsychotic (in chlorpromazine equivalents) and benzodiazepine used (in lorazepam equivalents)
timeFrame: Baseline to Week Two (End of Study)
measure: Total number of medications needed
timeFrame: Baseline to Week Two (End of Study)
measure: Differences in sleep efficiency as estimated from actigraphy
timeFrame: Baseline to Two Weeks (End of Study)
measure: Change in the Patient Mania Questionnaire - 9-Item Scale for Assessing and Monitoring Manic Symptoms (PMQ-9)
timeFrame: Baseline; Week One; Two Week (End of Study)
measure: Change in the Digital Self-Report Survey of Mood for Bipolar Disorder - 6-Item Digital Survey Measuring Mood Changes in Bipolar Disorder (digiBP)
timeFrame: Baseline; Week One; Two Week (End of Study)
measure: Change in Altman Self-Rating Mania Scale - 5-Item Self Rating Mania Scale (ASRM)
timeFrame: Baseline; Week One; Two Week (End of Study)
measure: Change in the Hamilton Depression Rating Scale - 21-Item for the Assessment of Depression Severity (HAM-D)
timeFrame: Baseline; Day 1-2; Day 3-5; Week One; Day 9-10; Day 11-12; Week Two (End of Study)
measure: Change in the Patient Health Questionnaire - 9-Item Measuring the Severity of Depression Symptoms (PHQ-9)
timeFrame: Baseline; Week One; Two Week (End of Study)
measure: Change in the General Anxiety Disorder Questionnaire- 7-Item Measuring Severity of Anxiety Symptoms (GAD-7)
timeFrame: Baseline; Week One; Two Week (End of Study)
measure: Change in The Morning Evening Questionnaire - 19-Item Self-Assessment Questionnaire for Sleep Rhythms, Habits and Fatigue (MEQ)
timeFrame: Baseline; Week One; Two Week (End of Study)
measure: Change in The Pittsburgh Sleep Quality Index - 18-Item Self-Assessment to Evaluate Sleep Quality (PSQI)
timeFrame: Baseline; Week One; Two Week (End of Study)
measure: Change in The Leeds Sleep Evaluation Questionnaire - 10-Item Self-Rating Scale of Sleep Behavior (LEEDS)
timeFrame: Baseline; Week One; Two Week (End of Study)
measure: Change in the Pre-Sleep Arousal Scale - 16-Item Self-Rated Scale of Symptoms of Arousal at Bedtime (PSAS)
timeFrame: Baseline; Week One; Two Week (End of Study)
measure: Change Circadian Rhythms
timeFrame: Inferred from melatonin/cortisol curves, rest-activity cycle (wrist actigraphy), heart rate/temperature monitoring, Electroencephalography
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Insitute
state: Ontario
city: Ottawa
country: Canada
facility: L'Hôpital Montfort
state: Ontario
Study officials:
affiliation: Head and Chief, Department of Mental Health, The Ottawa Hospital
name: Jess G Fiedorowicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: