Study on Disease Course and Quality of Life in Patients With Sleep Disorders (Mainz Sleep Registry)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 3 months (rating from 0 (no sleepiness) to 24 (severe sleepiness))
研究概览
简要总结
Prospective longitudinal observational registry study of all patients with sleep disorders treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.
详细描述
Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with narcolepsy
- •patients with other neurological sleep disorders
排除标准
- •patients aged <18 years
- •patients who cannot provide informed consent and don't have a legal guardian
结局指标
主要结局
Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 3 months (rating from 0 (no sleepiness) to 24 (severe sleepiness))
时间窗: 3 months
EDS measure by ESS at the follow-up after 3 months
European Quality of Life 5 dimensions Index (EQ 5D Index)
时间窗: 6 months
health-related quality of life measured by EQ5D-Index (European Quality of Life 5 dimensions), rating from 0 (worst possible state) to 1 (best possible state)
Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 6 months
时间窗: 6 months
EDS measure by ESS at the follow-up after 6 months (rating from 0 (no sleepiness) to 24 (severe sleepiness))
次要结局
- Beck Depression Inventory II(12 months)
- Ullanlinna Narcolepsy Scale (UNS)(6 months)
- Pittsburgh Sleep Quality Index(12 months)
- World Health Organization Quality of Life-BREF (WHOQOL-BREF)(12 months)
- Resilience Scale 13(12 months)
- Multidimensional Fatigue Inventory(6 months)
- European Quality of Life visual analogue scale (EQ-VAS)(12 months)
- Berlin Social Support Scales (BSSS)(12 months)
研究者
Dr. Yaroslav Winter
Head of Mainz Comprehensive Epilepsy and Sleep Medicine Center
Johannes Gutenberg University Mainz