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Search / Trial NCT06504342

Clocks in Sync - Circadian Rhythm and Bipolar Mania

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Jul 10, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Chronotherapy Blue Blocking Glasses Time Restricted Eating

ClinConnect Summary

The "Clocks in Sync" trial is exploring new ways to help people with bipolar disorder who are experiencing mania, a state where they may feel overly energetic and have trouble sleeping. This study is particularly interested in two treatments: blue-blocking glasses, which can help improve sleep by filtering out certain types of light, and time-restricted eating, which involves eating within specific hours of the day. The goal is to see if these methods can help manage manic symptoms and restore normal sleep patterns, offering a potentially safer alternative to traditional medications that often come with side effects.

To participate in this study, individuals need to be over 16 years old and have symptoms of mania that meet certain criteria. Participants will be asked to share their experiences in interviews, and their symptoms and activity levels will be monitored throughout the trial. It’s important to note that individuals with certain medical conditions, such as a history of eating disorders or severe brain injuries, may not be eligible. This pilot study will help gather valuable information to guide future research on these therapies, making it a crucial step toward improving care for those with bipolar mania.

Gender

ALL

Eligibility 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.

About Ottawa Hospital Research Institute

The Ottawa Hospital Research Institute (OHRI) is a leading academic research institute dedicated to advancing health and healthcare through innovative research and evidence-based practices. Affiliated with The Ottawa Hospital and the University of Ottawa, OHRI fosters a collaborative environment that brings together clinicians, scientists, and trainees to conduct groundbreaking clinical trials and translational research. With a focus on improving patient outcomes, OHRI specializes in a wide range of fields, including cancer, cardiovascular health, and regenerative medicine. The institute is committed to ethical research practices and the dissemination of knowledge to enhance public health and inform healthcare policy.

Locations

Ottawa, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Jess G Fiedorowicz, MD, PHD

Principal Investigator

Ottawa Hospital Research Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported