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NCT07194278Recruiting

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

Source: ClinicalTrials.gov · Last updated 26 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
25 (estimated)
First submitted
4 Feb 2025
Start date
19 Jul 2024
Primary completion date
1 Feb 2026
Lead sponsor
Centre Hospitalier St Anne
NCT number
NCT07194278

What you commit to

  • Study type: Interventional
  • Planned participants: 25
  • From 19 Jul 2024 to the primary completion date, 1 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient with severe eye problem or with an history of trauma affecting the eyes

Other

  • Patient who did not agree to participate to the study
  • Patient unable to be informed or understand the course of the study
  • Pregnant or breastfeeding women
  • Patient in need of urgent care

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Secteur de psychiatrie adulte G22-G23-G24
Coordinator of this site? Confirm its status
ParisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.