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Procedure

Blue-Blocking Glasses + Time-Restricted Eating for Bipolar Mania (CIS Trial)

N/A
Waitlist Available
Led By Jess G Fiedorowicz, MD, PHD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be over age 16
Have DSM-5-defined manic symptoms that persist beyond the physiological effects of a substance and a YMRS≥20
Must not have
Have a diagnosis of moderate to severe traumatic brain injury with residual or long-term effects, parenchymal brain surgery or stroke
Have a diagnosis of sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two 24-hour periods: one starting at the baseline visit and the other starting at the week 1 visit.
Awards & highlights

Summary

This trial will investigate the use of blue-blocking glasses and time-restricted eating to help manage symptoms of mania. Mania can disrupt sleep patterns, and current medications for mania can have side effects

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the interventions involve lifestyle adjustments like wearing tinted glasses and changing when you eat, they're considered safe with minimal side effects compared to medication. Specific side effects aren't listed but might include discomfort from wearing glasses or hunger from eating restrictions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 16 years old.
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I have manic symptoms not caused by substances with a YMRS score of 20 or more.
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I can read and understand English or French.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a serious brain injury, surgery, or stroke with lasting effects.
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I have been diagnosed with sleep apnea.
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I take medication that can lower my blood sugar.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week of continuous wearing starting at the baseline visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and one week of continuous wearing starting at the baseline visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of Time-Restricted Eating: 1) Study Participation
Feasibility of Time-Restricted Eating: 2) Adherence to Protocol
Feasibility of Time-Restricted Eating: 3) Qualitative Interviews
Secondary study objectives
Change in Circadian Rhythms: 1) Actigraphy
Change in Circadian Rhythms: 2) Heart Rate
Change in Circadian Rhythms: 3) Body Temperature
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Blue-blocking glasses and time-restricted eatingExperimental Treatment2 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 eatingActive Control1 Intervention
Participants will only be wearing the experimental blue-blocking glasses from 6pm-8am.
Group III: Lightly tinted glasses and time-restricted eatingActive Control2 Interventions
Participants will be wearing the control lightly tinted glasses and follow time-restricted eating from 6pm-8am.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blue-blocking glasses
2021
N/A
~140
Time-restricted eating
2022
N/A
~800

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
572 Previous Clinical Trials
2,788,992 Total Patients Enrolled
1 Trials studying Mania
51 Patients Enrolled for Mania
Jess G Fiedorowicz, MD, PHDPrincipal InvestigatorOttawa Hospital Research Institute
~20 spots leftby Jun 2025
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