Feasibility and Preliminary Results of the Efficacy of Blue-Blocking Glasses on Manic Symptoms in Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasability
研究概览
简要总结
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.
详细描述
- Patients' recruitment Patients experiencing a manic episode within the context of bipolar disorder type 1 will be recruited from the hospitalization department of sector G22 at GHU-Paris, located at the Maison Blanche - Bichat site. The physicians treating eligible patients will be able to invite them to participate in the study. They will provide an information sheet and explain the aims and objectives of the study, as well as the constraints related to participation. Patients suffering from a manic episode according to DSM-5 criteria are routinely hospitalized for longer than the intervention duration (7 days). Therefore, the entire follow-up can be conducted within the hospitalization service.
- Inclusion and study visits The participant will complete an initial questionnaire upon inclusion (D0), followed by two visits at D3 and D7 (end of the intervention). These are hetero-questionnaires to be completed via questionnaires on the RedCap® software. Additionally, participants will be asked to wear an actimetry watch continuously for the 7 days of the intervention.
2.1) Inclusion Visit
Once inclusion criteria are verified, the patient informed, and consent obtained, the inclusion questionnaire will be completed by the clinician in the presence of the participant. The inclusion questionnaire will consist of several sections:
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Sociodemographic data: age, sex, year of birth, lifestyle, education level, and professional activity.
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Clinical data: the psychiatric pathology presented by the participant, psychiatric and somatic comorbidities, ongoing medications.
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Evaluation of addictive behaviours (tobacco, alcohol, other psychoactive substances) through frequency and consumption level.
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Evaluation of clinical efficacy criteria based on the Young Mania Rating Scale (YMRS).
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The participant will also complete sleep evaluation questionnaires:
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Pittsburgh Sleep Quality Index (PSQI): a self-assessment questionnaire evaluating sleep quality; it consists of 19 questions and takes 5-10 minutes to complete.
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Insomnia Severity Index (ISI): a short scale (7 questions) to assess the nature of insomnia, sleep satisfaction, daily functioning, and anxiety about sleep disturbances.
During the inclusion visit, the participant will be provided with blue-blocking glasses along with the medical usage protocol and the actimetry watches. The patient will also begin filling out the sleep diary starting from inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Feasability
时间窗: 7 days after admission
Feasibility of the intervention will be assessed with an ad hoc questionnaire including recruitment rate, participation rate, the acceptability of the study protocol, patients' commitment to the intervention, etc.
次要结局
- Global functioning(7 days after admission)
- Patients' acceptability of the intervention(7 days after admission)
- Efficacy of blue-blocking glasses(Day 0, day 3 and day 7)
- Impact on sleep quality(Day 0, day 3 and day 7)
- Suicidal risk(Day 0 and day 7)