Effect of Sleep Disorder on Onset and Progression of Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- ALSFERS-R
研究概览
简要总结
200 cases of ALS patients were collected to explore whether sleep disorders are related to earlier onset age, and whether sleep disorders accelerate the progress of ALS and shorten the survival time of ALS patients.
详细描述
200 patients with ALS were collected. 1) sleep disorders were assessed by Pittsburgh sleep quality index (PSQI) and Epworth Sleepiness Scale (epworth) at baseline Sleeping Scale，ESS）； 2) Name, age, gender and onset site were collected to explore whether sleep disorders were associated with earlier onset age; 3) The patients' function (ALSFRS-R) at baseline and every 3 months within 2 years were collected, and the end-point time (death and invasive breathing) was recorded to evaluate whether sleep disturbance accelerated the decline of patients' function and shortened their short-term survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed in the Department of Neurology of the Third Hospital of Beijing Medical University since August
- •The clinical diagnosis of patients with amyotrophic lateral sclerosis includes: probable and define;
- •Informed consent has been signed.
排除标准
- •Those who can not cooperate to complete the scale and receive follow-up.
结局指标
主要结局
ALSFERS-R
时间窗: 2 years
ALS functional score
end point event
时间窗: 2 years
death or invasive breathing
次要结局
未报告次要终点