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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Secteur de psychiatrie adulte G22-G23-G24
RECRUITING
Paris
Time Frame
Start Date: 2024-07-19
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 25
Treatments
Experimental: Groupe intervention
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.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier St Anne

This content was sourced from clinicaltrials.gov

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