Clocks in Sync - Circadian Rhythm and Bipolar Mania (NCT06504342) | Clinical Trial Compass
CompletedNot Applicable
Clocks in Sync - Circadian Rhythm and Bipolar Mania
Canada21 participantsStarted 2024-09-17
Plain-language 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 can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at time-restricted eating as a way to sync circadian rhythms in people with bipolar disorder and mania — is there any evidence from studies like this one that changing meal timing could actually help manage my symptoms, or is this still very early-stage research?
2Since this trial was measuring feasibility — basically whether people could stick to a time-restricted eating schedule — rather than whether it actually treated mania, what does that mean about how much we know about whether this approach is safe or effective for someone in my situation?
3The trial is now completed, so would you be able to help me find any published results or findings from it, and what would those results tell us about whether time-restricted eating is something worth trying alongside my current treatment?
4Given that this study focused on circadian rhythms and bipolar mania, are there already standard approaches to managing sleep and daily routines — like social rhythm therapy — that might be worth trying first while this research is still being evaluated?
5If I were interested in dietary or lifestyle changes to support my circadian rhythm, is time-restricted eating something you'd feel comfortable guiding me on based on what's currently known, or would you want to wait for more evidence from trials like this one before recommending it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Time-Restricted Eating: 1) Study Participation
Timeframe: Over the lifetime of the study starting at the first patient approached until recruitment is stopped.
2
Feasibility of Time-Restricted Eating: 2) Adherence to Protocol
Timeframe: Baseline to Week 2 or until discharge, whichever comes first
3
Feasibility of Time-Restricted Eating: 3) Qualitative Interviews
Timeframe: One interview prior to the participant's discharge, at the end of their participation in the study.