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.
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.
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
Single group
Blue-blocking glasses
DeviceThe 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.
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.
Patients' acceptability of the intervention
Assessment is based on self-reported satisfaction criteria regarding the use of blue-blocking glasses, and to identify potential barriers to their use by bipolar patients.
Efficacy of blue-blocking glasses
Efficacy of the use of blue-blocking glasses among bipolar patients experiencing a manic episode is assessed with the Young Mania Rating Scale (YMRS). Use as a tool to assess and record the severity of a manic episode. The questionnaire consists of eleven items which the clinician rates based on the assessment of the patients current condition during the course of the interview. The total score which ranges from 0-60. A score of 20-30 points indicate moderate mania and \>30 points indicate severe mania.
Impact on sleep quality
Impact on sleep quality is evaluated by the Pittsburgh Sleep Quality Index (PSQI). The global score ranges 0 to 21. Higher scores indicate worse sleep quality.
Suicidal risk
Suicidal risk is determined using the Columbia Suicide Severity Rating Scale (CSSRS). It contains 6 "yes" or "no" questions to rate an individual's degree of suicidal ideation. Interpretation : 0 = No risk reported (all "no" responses) · 1 - 2 points = Low risk · 3 - 6 points = Moderate to high risk.
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