Clocks in Sync - Circadian Rhythm and Bipolar Mania

NCT ID: NCT06504342

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2025-10-31

Brief 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.

Detailed Description

This pilot study will assess feasibility and preliminary data for a novel circadian intervention in a clinical population that has been understudied, patients dealing with manic episodes of bipolar disorder, with an equity, diversity, and inclusion plan to ensure broad demographic representation.

The investigators' long-term goal is to conduct an innovative adaptive, 2x2 factorial study of these two interventions to determine the effects of each individual component and potential synergistic interactions. An adaptive design will allow interim analyses for sample size during which futility can also be assessed. This may potentially reduce cost and time of the later full trial, while ensuring that relevant findings are obtained. To inform a later 2x2 factorial study, researchers will need to gather data on the feasibility of time restricted eating in mania and identify any forms of support required to facilitate this chronotherapy. This is a randomized, parallel three group pilot study of blue-blocking glasses, time restricted eating, or blue-blocking glasses plus time-restricted eating in inpatients with mania. This project has three specific aims:

Aim 1: To assess the feasibility of time restricted eating (10:14 of diurnal eating to nocturnal fasting based on patient partners' input) as an adjunctive treatment for mania in an inpatient setting. Feasibility will be assessed through monitoring of adherence and qualitative semi-structured interviews with patient participants when they exit the study and staff near the study end date. The purpose of these interviews is to identify any challenges or barriers in implementing this treatment, alone or in combination with blue blocking glasses, and what supports might be needed. The research team will also assess willingness to participate in the study through assessment of participation rates and reasons for accepting or declining.

Aim 2: The investigators will secondarily compare differences between groups on the Young Mania Rating Scale (YMRS), which will be the primary outcome for the future trial.

Aim 3 (exploratory): To explore changes in measures of circadian rhythms and sleep, including as measured with actigraphy and other non-invasive monitoring measures, with the interventions and in relation to recovery from mania.

Conditions

Bipolar Disorder; Mania

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Blue-blocking glasses and time-restricted eating

Participants will be wearing the experimental blue-blocking glasses and follow time-restricted eating from 6pm-8am.

Group Type: EXPERIMENTAL

Blue-blocking glasses

Intervention Type: DEVICE

These lenses will filter \~10% of visible light across the visible light range (including in the range activating melanopsin) with complete blockade of ultraviolet light.

Time-restricted eating

Intervention Type: BEHAVIORAL

Avoid caloric food intake for a fourteen-hour period overnight from 6 p.m. to 8 a.m

Blue-blocking glasses and no time-restricted eating

Participants will only be wearing the experimental blue-blocking glasses from 6pm-8am.

Group Type: ACTIVE_COMPARATOR

Blue-blocking glasses

Intervention Type: DEVICE

These lenses will filter \~10% of visible light across the visible light range (including in the range activating melanopsin) with complete blockade of ultraviolet light.

Lightly tinted glasses and time-restricted eating

Participants will be wearing the control lightly tinted glasses and follow time-restricted eating from 6pm-8am.

Group Type: ACTIVE_COMPARATOR

Time-restricted eating

Intervention Type: BEHAVIORAL

Avoid caloric food intake for a fourteen-hour period overnight from 6 p.m. to 8 a.m

Lightly tinted glasses

Intervention Type: DEVICE

These lenses block shorter wavelengths of light, mainly ultraviolet light.

Interventions

Blue-blocking glasses

These lenses will filter \~10% of visible light across the visible light range (including in the range activating melanopsin) with complete blockade of ultraviolet light.

Intervention Type: DEVICE

Time-restricted eating

Avoid caloric food intake for a fourteen-hour period overnight from 6 p.m. to 8 a.m

Intervention Type: BEHAVIORAL

Lightly tinted glasses

These lenses block shorter wavelengths of light, mainly ultraviolet light.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jess G Fiedorowicz, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Ottawa Hospital Research Insitute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jess G Fiedorowicz, MD, PHD

Role: CONTACT

jfiedorowicz@toh.ca

+1 613-798-5555 ext. 78043

Jessica Yu, MSc

Role: CONTACT

jesyu@ohri.ca

Facility Contacts

Jess G Fiedorowicz, MD, PhD

Role: primary

jfiedorowicz@toh.ca

6137372210

Other Identifiers

20240219-01H

Identifier Type: -

Identifier Source: org_study_id