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

Recruiting now · Not applicable

Conditions studied: Bipolar 1 Disorder

In brief

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.

Key facts

Study ID: NCT07194278
Run by: Centre Hospitalier St Anne
People needed: 25
Starts: 2024-07-19
Expected to finish: 2026-09-01
Last updated by the study team: 2025-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Secteur de psychiatrie adulte G22-G23-G24 — Paris, France, France (enrolling)

Full record on ClinicalTrials.gov

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