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

Recruiting · NCT07194278 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier St Anne

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Bipolar disorder

Interventions studied

Blue-blocking glasses

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.

Exclusion criteria

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

1 location listed.

Secteur de psychiatrie adulte G22-G23-G24 - Paris, France, France

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →