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Clocks in Sync - Circadian Rhythm and Bipolar Mania

Bipolar Disorder | Mania

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    16 and up

Participation Criteria

Inclusion Criteria:

* Be over age 16
* Have DSM-5-defined manic symptoms that persist beyond the physiological effects of a substance and a YMRS≥20
* 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.

Exclusion Criteria:

* Have a history of eating disorders.
* Have a diagnosis of moderate to severe traumatic brain injury with residual or long-term effects, parenchymal brain surgery or stroke
* Have a neurocognitive disorder
* Take hypoglycemia-inducing medications
* Be pregnant/lactating women
* Have a diagnosis of sleep apnea
* Have any other medical condition for which physician or investigator team expresses concern about safety or ability to participate in the study.

Study Location

Ottawa Hospital Research Insitute
Ottawa Hospital Research Insitute
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Jess G Fiedorowicz, MD, PhD

[email protected]
6137372210
Study Sponsored By
Ottawa Hospital Research Institute
Participants Required
More Information
Study ID: NCT06504342