Clocks in Sync - Circadian Rhythm and Bipolar Mania

NCT06504342 | Completed DMC

• 1 other identifier: 20240219-01H
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Mania

Keywords

Chronotherapy; Blue-blocking glasses; Time-restricted eating

Outcome Measures

Primary Outcomes (3)

• Feasibility of Time-Restricted Eating: 1) Study Participation

  Feasibility of time restricted eating for inpatients with mania as assessed by study participation, defined as the ratio of patients who consent to participate in the study after being approached by the research team. This will be reported as a ratio with the number of participants who consented as the numerator and the total number of patients approached for participation in the study as the denominator.

  Over the lifetime of the study starting at the first patient approached until recruitment is stopped.

• Feasibility of Time-Restricted Eating: 2) Adherence to Protocol

  Feasibility of time restricted eating for inpatients with mania as assessed by self-reported and observed adherence. At each study visit, the research team will consider the participants' self-report, notes in the medical record, and their own observations to select a rating on a Likert scale indicating how closely the participant has adhered to the schedule of their assigned intervention(s): a) Fully adherent; b) Almost fully adherent; c) Mostly adherent; d) Half adherent; e) Mostly non-adherent; f) Barely adherent; g) Not adherent.

  Baseline to Week 2 or until discharge, whichever comes first

• Feasibility of Time-Restricted Eating: 3) Qualitative Interviews

  Feasibility of time restricted eating for inpatients with mania as assessed by qualitative semi-structured interview. The research team will conduct a semi-structured interview with participants to elicit their perspective on the feasibility of time restricted eating in the context of an inpatient research study.

  One interview prior to the participant's discharge, at the end of their participation in the study.

Secondary Outcomes (8)

• Change in the Young Mania Rating Scale

  Baseline to Week 2 or until discharge, whichever comes first

• Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score

  Baseline to Week 2 or until discharge, whichever comes first

• Change in the General Anxiety Disorder Questionnaire- 7-Item Measuring Severity of Anxiety Symptoms (GAD-7)

  Baseline to Week 2 or until discharge, whichever comes first

• Change in The Morning Evening Questionnaire - 19-Item Self-Assessment Questionnaire for Sleep Rhythms, Habits and Fatigue (MEQ)

  Baseline; Week 1; Week 2 or until discharge, whichever comes first

• Change in The Pittsburgh Sleep Quality Index - 18-Item Self-Assessment to Evaluate Sleep Quality (PSQI)

  Baseline; Week 1; Week 2 or until discharge, whichever comes first

Study Arms (3)

Blue-blocking glasses and time-restricted eating

EXPERIMENTAL

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

Device: Blue-blocking glasses; Behavioral: Time-restricted eating

Blue-blocking glasses and no time-restricted eating

ACTIVE COMPARATOR

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

Device: Blue-blocking glasses

Lightly tinted glasses and time-restricted eating

ACTIVE COMPARATOR

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

Behavioral: Time-restricted eating; Device: Lightly tinted glasses

Interventions

Blue-blocking glasses 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.

Blue-blocking glasses and no time-restricted eating; Blue-blocking glasses and time-restricted eating

Time-restricted eating BEHAVIORAL

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

Blue-blocking glasses and time-restricted eating; Lightly tinted glasses and time-restricted eating

Lightly tinted glasses DEVICE

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

Lightly tinted glasses and time-restricted eating

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Insitute

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder; Mania; Intermittent Fasting

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Jess G Fiedorowicz, MD, PHD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The time-restricted eating intervention will be single-blind, only the investigators/outcomes assessors will be blinded. The tinted glasses intervention will be double-blind.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 by 2 factorial design. Only 3 of the 4 arms will be implemented, with the double control arm not implemented in the pilot.

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 16, 2024
• Study Start: September 17, 2024
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)