Blue-Blocking Glasses + Time-Restricted Eating for Bipolar Mania

(CIS Trial)

Overseen By Jessica Yu, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Hypoglycemia-inducing

Disqualifiers: Eating disorders, Brain injury, Neurocognitive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether blue-blocking glasses and time-restricted eating can help manage mania symptoms by improving sleep patterns. Mania, characterized by extreme energy and mood changes, often disrupts the sleep-wake cycle. The researchers aim to find safer alternatives to medication. Participants will try different combinations of these therapies to determine which works best. The trial seeks individuals with ongoing manic symptoms not linked to substance use, who can read and understand English or French. As an unphased trial, this study offers a unique opportunity to explore innovative, non-medication-based treatments for mania.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking hypoglycemia-inducing medications, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have found blue-blocking glasses to be safe and comfortable for people with bipolar mania. Many participants noticed improvements in symptoms like trouble sleeping after using these glasses. Research also shows that these glasses might help reduce manic symptoms more quickly.

Time-restricted eating, which involves eating only during certain hours each day, has also proven safe. Studies indicate it is generally well-liked and may offer various health benefits. People who follow this eating pattern often experience a better mood and overall well-being.

Both treatments appear to be safe options without major side effects. However, the study aims to explore these therapies further to confirm their benefits and safety for people with mania. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about blue-blocking glasses and time-restricted eating for bipolar mania because these strategies offer a non-drug approach, which could minimize side effects compared to traditional medications like mood stabilizers and antipsychotics. Blue-blocking glasses limit exposure to blue light, which may help regulate sleep and mood by affecting melatonin production. Time-restricted eating could help stabilize mood by aligning eating patterns with the body's natural circadian rhythms. Unlike standard treatments that often take time to show effectiveness, these methods might offer quicker benefits by targeting lifestyle and environmental factors.

What evidence suggests that this trial's treatments could be effective for mania?

In this trial, participants will join different treatment arms to evaluate the effects of blue-blocking glasses and time-restricted eating on bipolar mania. Research shows that blue-blocking glasses, which some participants will wear, can reduce mania symptoms more quickly by blocking blue light, which can interfere with sleep and mood. Studies have found that wearing them from 6 PM to 8 AM can lessen manic symptoms in just a few days.

Time-restricted eating, another treatment option in this trial, involves eating only during certain hours each day. Evidence suggests it can boost mood and well-being in people with mood disorders. Some studies indicate it can increase alertness and improve overall mood. However, more research is needed to fully understand its effects on mania. ^{1 3 6 7 8}

Who Is on the Research Team?

Jess G Fiedorowicz, MD, PhD

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals experiencing mania as part of bipolar disorder. Participants should be interested in non-medication therapies and willing to try special glasses or change their eating patterns. Details on specific inclusion or exclusion criteria are not provided, but typically these would outline who can safely participate.

Inclusion Criteria

I am over 16 years old.

I have manic symptoms not caused by substances with a YMRS score of 20 or more.

Be willing to have investigators obtain information from the treatment team and electronic medical record

Exclusion Criteria

Have a history of eating disorders

I have had a serious brain injury, surgery, or stroke with lasting effects.

Have a neurocognitive disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive blue-blocking glasses, time-restricted eating, or both as interventions for mania

2 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Qualitative Interviews

Interviews conducted to assess feasibility and identify barriers to treatment

End of participation

What Are the Treatments Tested in This Trial?

Interventions

• Blue-blocking glasses
• Time-restricted eating

Trial Overview The study tests the effectiveness of blue-blocking glasses and time-restricted eating on managing symptoms of mania in bipolar disorder. It aims to see if these treatments can help regulate sleep-wake cycles without medication, using interviews and symptom tracking.

How Is the Trial Designed?

Group I: Blue-blocking glasses and time-restricted eating Experimental Treatment 2 Interventions

Participants will be wearing the experimental blue-blocking glasses and follow time-restricted eating from 6pm-8am.

Group II: Blue-blocking glasses and no time-restricted eating Active Control 1 Intervention

Participants will only be wearing the experimental blue-blocking glasses from 6pm-8am.

Group III: Lightly tinted glasses and time-restricted eating Active Control 2 Interventions

Participants will be wearing the control lightly tinted glasses and follow time-restricted eating from 6pm-8am.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

In a study of 61 individuals with bipolar disorder, 13% were diagnosed with binge eating disorder (BED) and 25% exhibited partial binge eating syndrome, indicating a higher prevalence of these eating disorders compared to community samples.

The study also found that 10 subjects reported night binge eating, typically occurring between 2:00 and 4:00 a.m., suggesting a potential link between mood regulation and binge eating behaviors in bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidity of binge eating disorder and the partial binge eating syndrome with bipolar disorder. Krüger, S., Shugar, G., Cooke, RG.[2004]

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., et al.[2021]

In patients with bipolar disorder, later dinnertime is linked to increased waist circumference, suggesting that meal timing may influence cardiometabolic risk.

Longer intervals between breakfast and lunch are also associated with greater waist circumference, indicating that meal frequency and timing could play a role in managing weight and cardiovascular health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between meal timing and frequency with cardiometabolic profile in patients with bipolar disorder. Soreca, I., Wallace, ML., Hall, MH., et al.[2018]

In a study of 1,572 southern Italian adults, time-restricted feeding (TRF) was associated with lower signs of mental health distress in individuals over 70 years old, suggesting a potential benefit of this dietary pattern for older adults.

However, the association was influenced by whether participants had breakfast, indicating that meal timing and dietary habits may interact in complex ways affecting mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding is associated with mental health in elderly Italian adults. Currenti, W., Godos, J., Castellano, S., et al.[2021]

In a study of 783 adults with bipolar disorder, those with an evening chronotype exhibited significantly higher rates of disordered eating behaviors, including binge-eating and bulimia nervosa, as well as poorer dietary habits compared to non-evening types.

The findings suggest that circadian system dysfunction, indicated by evening chronotype, may contribute to unhealthy eating patterns in bipolar disorder patients, highlighting the potential for targeting circadian rhythms in future therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evening chronotype, disordered eating behavior, and poor dietary habits in bipolar disorder. Romo-Nava, F., Blom, TJ., Guerdjikova, A., et al.[2021]

In a study of 69 bipolar disorder patients, irregular patterns in the timing of daily eating events were found to correlate with hypomanic symptoms, indicating that mood instability may influence eating behaviors.

The research introduced new methods to quantify eating patterns, which could help in understanding the relationship between eating habits and mood disorders in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irregular eating patterns associate with hypomanic symptoms in bipolar disorders. Buyukkurt, A., Bourguignon, C., Antinora, C., et al.[2021]

In a study of 51 outpatients with bipolar disorder, 14 patients (27.5%) were found to have eating disorders, specifically binge eating disorder (BED) or bulimia nervosa (BN), indicating a significant overlap between these conditions.

The majority of patients developed their eating disorders either coinciding with or after the onset of bipolar disorder, suggesting that emotional regulation through food may play a role in the development of these eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between bipolar illness and binge-eating disorders. Ramacciotti, CE., Paoli, RA., Marcacci, G., et al.[2008]

In a 12-week study involving 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

In a 12-week study involving 20 adults with a BMI of 25 kg/m2 or higher, time-restricted eating (TRE) significantly reduced the frequency of eating occasions by 28% compared to only 12% in the non-TRE group, indicating a more structured eating pattern.

TRE participants also reported a notable decrease in both high and low-quality snacks and caffeinated beverage intake, suggesting that this eating pattern not only aids in weight loss but also promotes healthier dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. Malaeb, S., Harindhanavudhi, T., Dietsche, K., et al.[2022]

Intermittent fasting (IF) participants, consisting of 44 women and 20 men, reported higher levels of eating disorder (ED) symptomatology compared to community norms, with 31.25% scoring at or above the clinical cutoff on the Eating Disorder Examination Questionnaire (EDE-Q).

The study indicates a concerning association between IF and ED behaviors, suggesting that individuals engaging in IF may be at risk for developing or exhibiting disordered eating patterns, highlighting the need for further research on this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting implementation and association with eating disorder symptomatology. Cuccolo, K., Kramer, R., Petros, T., et al.[2022]

Time-restricted eating (TRE) can lead to a weight loss of 1-4% over 1-16 weeks in individuals with obesity, primarily due to unintentional reductions in daily calorie intake of about 350-500 kcal.

TRE is effective in improving cardiovascular health by lowering fat mass, blood pressure, triglyceride levels, and markers of oxidative stress, and it is considered safe with few adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. Gabel, K., Cienfuegos, S., Kalam, F., et al.[2021]

In a study involving 32 participants over six weeks, the Time-restricted Feeding (TRF) diet was found to be the most acceptable, with participants reporting it as the easiest to follow compared to Early Time-restricted Feeding (eTRF) and Alternate Day Fasting (ADF).

Despite differences in dietary acceptability, there were no significant differences in weight loss or energy intake among the three fasting protocols, indicating that adherence may be more influenced by personal preference than by the specific diet's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches. Turner-McGrievy, GM., Wirth, MD., Bernhart, JA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5089565/

Blue‐blocking glasses as additive treatment for mania Conclusions. This RCT shows that BB glasses are effective and feasible as add‐on treatment for bipolar mania.

2. journals.lww.com journals.lww.com/ebp/fulltext/2024/10000/is_adjunctive_treatment_with_blue_blocking_glasses.18.aspx

Is adjunctive treatment with blue-blocking glasses (virtual .. ... In adults with bipolar-associated mania, adjunctive treatment with blue-blocking glasses (virtual darkness) may reduce manic symptoms more rapidly than ...

3. trial.medpath.com trial.medpath.com/clinical-trial/16fa661fe5d23b7e/nct07194278-blue-blocking-glasses-manic-symptoms-bipolar-disorder

Feasibility and Preliminary Results of the Efficacy of Blue ... In addition, the study will evaluate the impact of the use of blue-blocking glasses on the severity of manic symptoms, sleeping pattern (quality ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.12984

Blue‐blocking glasses as additive treatment for mania ... Blue-blocking (BB) glasses as adjunctive treatment hasten overall recovery from mania. This method is an evolvement from dark therapy.

5. tandfonline.com tandfonline.com/doi/full/10.1080/07853890.2023.2292250

stabilizing mood and sleep with blue blocking eyewear in ... The use of BB glasses from 6 PM to 8 AM led to a significant reduction in manic symptoms after 3 days, and the effect increased further throughout the 7-day ...

6. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.pn.2016.8a24

Blue Light–Blocking Glasses May Reduce Bipolar Mania According to Phelps, more than half of the bipolar patients he sees have reported improvements in manic symptoms, like insomnia, after using the ...

7. mdpi.com mdpi.com/2077-0383/11/5/1380

Blue Light Blocking Treatment for the Treatment of Bipolar ... Blue-light blocking (or 'amber') glasses have been proposed as a remedy for users of LED devices who are exposed to this radiation for a ...

8. ctv.veeva.com ctv.veeva.com/study/feasibility-and-preliminary-results-of-the-efficacy-of-blue-blocking-glasses-on-manic-symptoms-in-bi

Feasibility and Preliminary Results of the Efficacy of Blue ... In addition, the study will evaluate the impact of the use of blue-blocking glasses on the severity of manic symptoms, sleeping pattern (quality ...