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Clocks in Sync - Circadian Rhythm and Bipolar Mania

NCT06504342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-02-18

No results posted yet for this study

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

Interventions

DEVICE

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.

BEHAVIORAL

Time-restricted eating

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

DEVICE

Lightly tinted glasses

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

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Jess G Fiedorowicz, MD, PHD · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2025-10-02
Completion
2025-10-02

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06504342 on ClinicalTrials.gov