跳至主要内容
临床试验/NCT02843737
NCT02843737已完成不适用

Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI)

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
3
主要终点
Comparison between mathematical analysis and clinician interpretation of polysomnographic datas recorded under spontaneous breathing

研究概览

简要总结

The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep fragmentation on 405 patients who will perform a polysomnography under spontaneous breathing.

详细描述

Sleep fragmentation is one of the main problems of sleep disorders especially in respiratory failure. During this last decade, several indicators of sleep fragmentation were introduced but none of them seems to take into account the succession of sleep stages. To tackle with this problem, The investigators used the Shannon entropy index for modelling sleep stages diversity from an hypnogram and for assessing more accurately sleep quality by quantifying its fragmentation. The investigators developed a new tool we called Sleep Diversity Index (SDI).

In a retrospective study, the investigators calculated Sleep diversity index for 55 healthy subjects and 56 patients with suspected sleep apnea syndrom. Using the receiver operating characteristic (ROC) curves the threshold of fragmentation was determined at 20%. If SDI is lower than 20%, then sleep is considered as non-fragmented and otherwise, sleep is considered as fragmented.

To validate our SDI it is necessary to compare this diagnosis tool to a "gold standard" based on the clinician diagnosis and a mathematical diagnosis index created from objective criteria of polysomnography. The investigators propose a multicenter study to validate the SDI as a diagnosis tool of sleep fragmentation.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Spontaneous polysomnography

排除标准

  • Patients with psychoactive drug having an important effect on sleep

结局指标

主要结局

Comparison between mathematical analysis and clinician interpretation of polysomnographic datas recorded under spontaneous breathing

时间窗: One night

In order to determine the fragmentation of patient's sleep with two different approach and test the sleep diversity index .

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
申办方类型
Other
责任方
Sponsor

研究点 (3)

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