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Feasibility and Preliminary Results of the Efficacy of Blue-Blocking Glasses on Manic Symptoms in Bipolar Disorder

NCT07194278 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-09-26

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the feasibility of conducting a clinical trial of the use of blue-blocking glasses among patients with a type1 bipolar disorder, experiencing a manic episode. The feasibility criteria include: recruitment rates, participation rates, adherence to the research protocol, the material feasibility of the study. Feasibility criteria will be assessed at the end of the study period.

The investigators also want to assess patients' acceptability regarding the use of blue-blocking glasses during a manic episode, using self-reported satisfaction criteria. Those criteria will be monitored at the end of participation period for each patient (7 days after inclusion).

In addition, the study will evaluate the impact of the use of blue-blocking glasses on the severity of manic symptoms, sleeping pattern (quality of sleep, sleep latency, night wake, etc.), global functioning, and on suicidal ideations. Those indicators will be assessed at day 0 (inclusion), day 3 and day 7, using validated questionnaires and actimetry data.

The study is presented to all patients over 18 years old, with type 1 bipolar disorder, presenting a manic episode, hospitalised in an adult psychiatric ward of Bichat Hospital (GHU Paris).

Patients' participation duration is of 7 days after inclusion.

Conditions

  • Bipolar 1 Disorder

Interventions

DEVICE

Blue-blocking glasses

The intervention will last for 7 days, during which patients are required to wear the glasses from 6 p.m. to 8 a.m. and whenever a light is turned on during this interval. Additionally, patients will be asked to wear an actimeter and fill out a sleep diary each day. Doctors will conduct daily interviews to assess manic symptoms, with more in-depth assessments scheduled on days 0, 3, and 7 to evaluate other clinical characteristics.

Sponsors & Collaborators

  • Centre Hospitalier St Anne

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-19
Primary Completion
2026-02-01
Completion
2026-09-01

Countries

  • France

Study Locations

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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 NCT07194278 on ClinicalTrials.gov