Ottawa Sunglasses at Night for Mania Study

Bipolar Disorder Clinical Trial

— OSAN  

Official title:

A Randomized Control Trial of the Effectiveness of Blue-blocking Glasses for Mania in Inpatients With Bipolar Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206747
• Other study ID #: 20210790-01H
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Ottawa Hospital Research Institute
• Contact: Jess G Fiedorowicz, MD, PhD
• Phone: 6137372210
• Email: jfiedorowicz[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Mania
• Sleep

Intervention

Device:
• Blue-blocking glasses
It will transmit 45% of visible light with the following light transmission profile.
• 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.

Locations

Country	Name	City	State
Canada	L'Hôpital Montfort	Ottawa	Ontario
Canada	Ottawa Hospital Research Insitute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Young Mania Rating Scale	The Young Mania Rating Scale is used to evaluate the severity of manic symptoms at baseline and over time in individuals with mania. It is an 11-item scale and total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score =12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). We will model differences between groups in the primary outcome using linear mixed models (group by time interaction) including a random intercept term for participant.	Baseline to Week 2 (End of Study)
Secondary	Amount of antipsychotic (in chlorpromazine equivalents) and benzodiazepine used (in lorazepam equivalents)	Medication use will be abstracted from the medication administration record to assess need for scheduled and as needed antipsychotics and benzodiazepines.	Baseline to Week Two (End of Study)
Secondary	Total number of medications needed	Medication use will be abstracted from Medication Administration Records of the Electronic Medical Record.	Baseline to Week Two (End of Study)
Secondary	Differences in sleep efficiency as estimated from actigraphy	In a subsample of the study, validated monitors will also be used for non-invasive and wireless continuous monitoring of movements through wrist actigraphy (Actiwatch Spectrum Plus, Philips Healthcare, Bend, USA)	Baseline to Two Weeks (End of Study)
Secondary	Change in the Patient Mania Questionnaire - 9-Item Scale for Assessing and Monitoring Manic Symptoms (PMQ-9)	All items in the Patient Mania Questionnaire included time frame and stem-phrase format of "Over the past week, how often have you….". The Patient Mania Questionnaire item responses ranged from 0 to 3 with 0 indicating "not at all," 1 indicating "several days," 2 indicating "more than half of days," and 3 indicating "nearly every day." Item scores were added so that the total score ranged from 0 to 27 with higher scores representing greater severity.	Baseline; Week One; Two Week (End of Study)
Secondary	Change in the Digital Self-Report Survey of Mood for Bipolar Disorder - 6-Item Digital Survey Measuring Mood Changes in Bipolar Disorder (digiBP)	The survey contains six items three items measure depressive symptoms (depressed mood, fidgeting, and fatigue), two items measure manic symptoms (increased energy, rapid speech), and one item measures both (irritability). Participants rate symptoms on an ordinal scale: 0 = absent/normal, 1 = mild, 2 = moderate, 3 = severe. Items can be aggregated into two scores to reflect depressive symptom severity and manic symptom severity. Higher depression and manic scores reflect more severe depressive and manic symptoms, respectively. Since item responses range from 0 to 3, the depression score ranges from 0 (no symptoms) to 21 (all depressive symptoms are severe), whereas the manic score ranges from 0 (no symptoms) to 15 (all manic symptoms are severe).	Baseline; Week One; Two Week (End of Study)
Secondary	Change in Altman Self-Rating Mania Scale - 5-Item Self Rating Mania Scale (ASRM)	The Altman Self-Rating Mania Scale is a 5-item self-rating mania scale designed to assess the presence and/or severity of manic symptoms. Each item on the measure is rated on a 5-point scale (i.e., 1 to 5) with the response categories having different anchors depending on the item. The Altman Self-Rating Mania Scale score range from 5 to 25 with higher scores indicating greater severity of manic symptoms.	Baseline; Week One; Two Week (End of Study)
Secondary	Change in the Hamilton Depression Rating Scale - 21-Item for the Assessment of Depression Severity (HAM-D)	The scale is widely available and has two common versions with either 1 and is scored between 0 and 4 points. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.	Baseline; Day 1-2; Day 3-5; Week One; Day 9-10; Day 11-12; Week Two (End of Study)
Secondary	Change in the Patient Health Questionnaire - 9-Item Measuring the Severity of Depression Symptoms (PHQ-9)	Self-reported measurement of the severity of depression symptoms experienced within the last two weeks. The survey consists of 9 items. Participants are asked to rate each symptom of depression on a Likert scale, providing a score between 0 (not at all) and 3 (nearly every day). This yields a total score ranging from 0 (minimal depression) to 27 (severe depression). Higher scores thus indicate a greater severity of depressive symptoms, and are interpreted in the following manner: a score of 0-4 indicates minimal depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, a score of 15-19 indicates moderately severe depression, and a score of 20-27 indicates severe depression.	Baseline; Week One; Two Week (End of Study)
Secondary	Change in the General Anxiety Disorder Questionnaire- 7-Item Measuring Severity of Anxiety Symptoms (GAD-7)	Self-reported measurement of the severity of anxiety symptoms experienced within the last two weeks. It consists of 7 scored items and one follow-up question. Each of the 7 scored items generates a value from 0 (not at all) to 3 (nearly every day), yielding a total score ranging from 0 to 21, with higher scores indicating more severe symptoms of anxiety. These scores are interpreted in the following manner: a score of 0-4 indicates little or no anxiety, a score of 5-9 indicates mild anxiety, a score of 10-14 indicates moderate anxiety, and a score of 15-21 indicates severe anxiety. Generally, a score of 10 or above is considered to be a clinical cutoff implying that the respondent may be suffering from a general anxiety disorder.	Baseline; Week One; Two Week (End of Study)
Secondary	Change in The Morning Evening Questionnaire - 19-Item Self-Assessment Questionnaire for Sleep Rhythms, Habits and Fatigue (MEQ)	This questionnaire has 19 questions, each with a number of points. Scores can range from 16-86. Scores of 41 and below indicate "evening types." Scores of 59 and above indicate "morning types." Scores between 42-58 indicate "intermediate types."	Baseline; Week One; Two Week (End of Study)
Secondary	Change in The Pittsburgh Sleep Quality Index - 18-Item Self-Assessment to Evaluate Sleep Quality (PSQI)	The Pittsburg Sleep Quality Index Questionnaire is self-administered questionnaire designed to evaluate sleep quality consisting of 18 items that in turn are comprised of seven components, which include subjective sleep quality, sleep duration, sleep onset, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. Each weighted equally on a 0-3 scale to be summed to yield a global PSQI score, which ranges between 0 and 21, where the higher the scores, the worse the sleep quality. The investigators will only be using questions 1-4 and 6.	Baseline; Week One; Two Week (End of Study)
Secondary	Change in The Leeds Sleep Evaluation Questionnaire - 10-Item Self-Rating Scale of Sleep Behavior (LEEDS)	The Leeds Sleep Evaluation Questionnaire comprises ten self-rating 100-mm-line analogue questions concerned with aspects of sleep and early morning behavior. A 10-cm line separates the two halves of each question. The questionnaire instructions are" "Each question is answered by placing a vertical mark on the answer line. If no change was experienced then place your mark in the middle of the line. If a change was experienced then the position of your mark will indicate the nature and extent of the change, i.e. large charges near the ends of the line, small changes near the middle." The questionnaire monitors subjectively perceived changes in sleep. Improvements in the self-reported ratings relate to improved perceived quality of sleep.	Baseline; Week One; Two Week (End of Study)
Secondary	Change in the Pre-Sleep Arousal Scale - 16-Item Self-Rated Scale of Symptoms of Arousal at Bedtime (PSAS)	The Pre-Sleep Arousal Scale contains 16 items, each rated on a 5-point scale that describes symptoms of arousal at bedtime. Eight items evaluates cognitive arousal and eight evaluates somatic arousal. Total score scores range from 16 to 80, with higher scores suggest higher pre-sleep arousal.	Baseline; Week One; Two Week (End of Study)
Secondary	Change Circadian Rhythms	Substudy for subsample (measured at Baseline and Week One)	Inferred from melatonin/cortisol curves, rest-activity cycle (wrist actigraphy), heart rate/temperature monitoring, Electroencephalography