跳至主要内容
临床试验/NCT03629834
NCT03629834已完成不适用

Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2018年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
1
主要终点
Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment

研究概览

简要总结

Presently, there isn't any international recommendation to evaluate vigilance in Obstructive Sleep Apnea Syndrome. The French Society of Sleep Research and Medicine (SFRMS) recommend evaluating professional driver with a MWT but no recommendation exists for other patients. After a minimal treatment of 4 weeks, the physician has to evaluate the drowsiness risk of these patients using either an objective test like the MWT or a subjective one. In the university hospital Amiens-Picardie, since the 01/01/2015, every patient with an Obstructive Sleep Apnea Syndrome diagnosed by a polysomnography or a ventilatory polygraphy had a MWT after 4 weeks of treatment. At each time of the evaluation, Epworth Sleepiness Scale, tiredness score of Pichot, and depressive score of Beck are performed.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients treated by CPAP for Obstructive Sleep Apnea Syndrome

排除标准

  • Central Apnea Syndrome
  • Central Hypersomnia

结局指标

主要结局

Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment

时间窗: one day

Two levels of vigilance are defined by the ESS score: score ≥11: bad vigilance, \<11: good vigilance

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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