Actively Recruiting
Feasibility and Preliminary Results of the Efficacy of Blue-Blocking Glasses on Manic Symptoms in Bipolar Disorder
Led by Centre Hospitalier St Anne · Updated on 2025-09-26
25
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Feasibility and Preliminary Results of the Efficacy of Blue-Blocking Glasses on Manic Symptoms in Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Diagnosed with type 1 bipolar disorder experiencing a manic episode according to DSM-5 TR, with or without psychotic disorders
You will not qualify if you...
- Patient who does not agree to participate in the study
- Patient unable to understand or be informed about the study
- Patient with severe eye problems or history of eye trauma
- Pregnant or breastfeeding women
- Patient requiring urgent care
AI-Screening
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Trial Site Locations
Total: 1 location
1
Secteur de psychiatrie adulte G22-G23-G24
Paris, France, France, 75018
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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