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

NCT07194278 | Recruiting DMC

• 2 other identifiers: D24_EPI0392024-A00802-45
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bipolar 1 disorder; blue-blocking glasses; manic episode

Outcome Measures

Primary Outcomes (1)

• Feasability

  Feasibility of the intervention will be assessed with an ad hoc questionnaire including recruitment rate, participation rate, the acceptability of the study protocol, patients' commitment to the intervention, etc.

  7 days after admission

Secondary Outcomes (7)

• Patients' acceptability of the intervention

  7 days after admission

• Efficacy of blue-blocking glasses

  Day 0, day 3 and day 7

• Impact on sleep quality

  Day 0, day 3 and day 7

• Suicidal risk

  Day 0 and day 7

• Global functioning

  7 days after admission

Study Arms (1)

Groupe intervention

EXPERIMENTAL

he 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.

Device: Blue-blocking glasses

Interventions

Blue-blocking glasses DEVICE

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.

Groupe intervention

Eligibility Criteria

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

You may qualify if:

• Patient over 18 years old
• Patient with a type 1 bipolar disorder presenting a manic episode according to the DSM-5 TR, with or without associated psychotic disorders.

You may not qualify if:

• Patient who did not agree to participate to the study
• Patient unable to be informed or understand the course of the study
• Patient with severe eye problem or with an history of trauma affecting the eyes
• Pregnant or breastfeeding women
• Patient in need of urgent care

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

Secteur de psychiatrie adulte G22-G23-G24

Paris, France, 75018, France

RECRUITING

MeSH Terms

Conditions

Mania

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: September 26, 2025
• Study Start: July 19, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

FR (1)