NCT01766063已完成不适用
BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 138
- 主要终点
- Functional health status assessed by Short Form-36 (SF-36)
研究概览
简要总结
The study aims to investigate the relationship between sleep quality, quality of life,other disorders and therapies in Multiple Sclerosis (MS) patients treated with Betaferon.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients ≥ 18 years of age with relapsing remitting multiple sclerosis or a clinically isolated syndrome and an expanded disability status scale score ≤
- •Patients must be on treatment with Betaferon and tolerate Betaferon according to the investigator's evaluation, but should not have received Betaferon longer than six months.
- •Written informed consent must be obtained
排除标准
- •Patients who do not tolerate Betaferon according to the investigator's evaluation or have been treated with Betaferon for more than six months.
- •Patients receiving any other disease modifying drug or MS specific treatments
- •Contraindications of Betaferon described in the Summary of Product Characteristics.
研究组 & 干预措施
Group 1
干预措施: Interferon beta-1b (Betaferon, BAY 86-5046) (Drug)
结局指标
主要结局
Functional health status assessed by Short Form-36 (SF-36)
时间窗: up to 3 years
Fatique assessed by the Modified Fatigue Impact Scale (MFIS)
时间窗: up to 3 years
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)
时间窗: up to 3 years
次要结局
- Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)(up to 3 years)
- Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)(up to 3 years)
- Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)(up to 3 years)
- Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.(up to 3 years)
研究者
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