Evaluation of automated and semi-automated scoring of polysomnographic recordings from a clinical trial using zolpidem in the treatment of insomnia
Evaluation of automated and semi-automated scoring of polysomnographic recordings from a clinical trial using zolpidem in the treatment of insomnia
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DOI：
10.1093/sleep/30.11.1562
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发表时间：
2007-11-01
期刊：
影响因子：
5.6
通讯作者：
Koblan, Ken S.
中科院分区：
文献类型：
--
作者：
Svetnik, Vladimir;Ma, Junshui;Koblan, Ken S.
目的评价Morpheus和Somnolyzer 24 X7两种自动化系统对唑吡坦治疗短暂性失眠症患者的多导睡眠图（PSG）记录进行评分的性能。方法收集82名受试者2个晚上睡眠的164个PSG记录，其中1个接受安慰剂治疗，1个接受唑吡坦（10 mg）治疗。对于每个记录，使用6种不同的方法来提供基于Rechtschaffen & Kales标准的睡眠阶段评分：1）完全手动评分，2）由Morpheus自动评分，3）由Somnolyzer 24 X7自动评分，4）由Morpheus自动评分和完全手动审查，5）由Morpheus自动评分和部分手动审查，6）由Somnolyzer 24 X7自动评分和部分手动审查。10个传统的临床疗效措施的睡眠启动，维护和架构calculated.ResultsPair-wise逐时协议之间的全自动和手动评分的范围内的站点间手动评分协议在文献中报道（70%-72%）。手动审查的自动评分之间的逐时配对一致性较高（73%-76%）。无论使用哪种方法，使用传统疗效终点的治疗效应量的方向和统计学显著性基本相同。随着人工审查程度的增加，效果大小的幅度接近那些估计与完全手动scoring.ConclusionAutomated或半自动化的睡眠PSG评分提供了宝贵的替代品，昂贵的，耗时的，intrasite和intersite变量手动评分，特别是在大型多中心临床试验。评分变异性的降低也可能减少临床试验的样本量。
ObjectiveTo evaluate the performance of 2 automated systems, Morpheus and Somnolyzer24X7, with various levels of human review/editing, in scoring polysomnographic (PSG) recordings from a clinical trial using zolpidem in a model of transient insomnia.Methods164 all-night PSG recordings from 82 subjects collected during 2 nights of sleep, one under placebo and one under zolpidem (10 mg) treatment were used. For each recording, 6 different methods were used to provide sleep stage scores based on Rechtschaffen & Kales criteria: 1) full manual scoring, 2) automated scoring by Morpheus 3) automated scoring by Somnolyzer24X7, 4) automated scoring by Morpheus with full manual review, 5) automated scoring by Morpheus with partial manual review, 6) automated scoring by Somnolyzer24X7 with partial manual review. Ten traditional clinical efficacy measures of sleep initiation, maintenance, and architecture were calculated.ResultsPair-wise epoch-by-epoch agreements between fully automated and manual scores were in the range of intersite manual scoring agreements reported in the literature (70%–72%). Pair-wise epoch-by-epoch agreements between automated scores manually reviewed were higher (73%–76%). The direction and statistical significance of treatment effect sizes using traditional efficacy endpoints were essentially the same whichever method was used. As the degree of manual review increased, the magnitude of the effect size approached those estimated with fully manual scoring.ConclusionAutomated or semi-automated sleep PSG scoring offers valuable alternatives to costly, time consuming, and intrasite and intersite variable manual scoring, especially in large multicenter clinical trials. Reduction in scoring variability may also reduce the sample size of a clinical trial.