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Procedure

Blue-blocking glasses and time-restricted eating for Bipolar Disorder (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
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

The sleep-wake cycle is severely disrupted during an episode of mania. Often mania is treated with medications that can come with significant side effects. Years of patient and family engagement with this population have revealed great interest in therapies targeting the sleep-wake cycle. However, there is still a lack of studies to support using these treatments for mania. Patient partners are especially interested in two specific therapies for mania, blue-blocking glasses and time-restricted eating, because of their perceived feasibility and safety. This pilot study will formally investigate the feasibility and effectiveness of these therapies for participants with mania, an understudied population that faces many difficulties even after recovery. The pilot study will collect interviews to identify barriers and ways to better support patients with mania using the therapies. The study will also investigate how well these therapies can treat manic symptoms and restore sleep-wake cycles by tracking symptom rating scales and measuring activity levels. Results from this pilot will be used to direct a larger study that will use a state-of-the art design to test the effectiveness of both therapies alone and in combination.

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one interview prior to the participant's discharge, at the end of their participation in the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and one interview prior to the participant's discharge, at the end of their participation in the study. 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
Time-restricted eating
2022
N/A
~550
Blue-blocking glasses
2021
N/A
~140

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
572 Previous Clinical Trials
2,789,142 Total Patients Enrolled
2 Trials studying Bipolar Disorder
91 Patients Enrolled for Bipolar Disorder
Jess G Fiedorowicz, MD, PHDPrincipal InvestigatorOttawa Hospital Research Institute
~20 spots leftby Jun 2025
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