Advanced Analysis of Pharmaco-Sleep Data in Humans.

Pharmaco-sleep studies in humans aim at the description of the effects of drugs, most frequently substances that act on the central nervous system, by means of quantitative analysis of biosignals recorded in subjects during sleep. Up to 2007, the only standard for the classification of sleep macrostructure that found worldwide acceptance were the rules published in 1968 by Rechtschaffen and Kales. In May 2007, the AASM Manual for the Scoring of Sleep and Associated Events was published by the American Academy of Sleep Medicine, and concerning the classification of sleep stages, these new rules are supposed to replace those developed by Rechtschaffen and Kales. As compared to the rather low interrater reliability of manual sleep scoring, semiautomated approaches may achieve a reliability close to 1 (Cohen's kappa 0.99 for 2 semiautomated scorings as compared to 0.76 for 2 manual scorings) without any decline in validity. Depending on the aim of the pharmaco-sleep study, additional analyses concerning sleep fragmentation, sleep microstructure, sleep depth, sleep processes and local aspects of sleep should be considered. For some of these additional features, rules for visual scoring have been established, while for others automatic analysis is obligatory. Generally, for reasons of cost-effectiveness but also reliability, automatic analysis is preferable to visual analysis. However, the validity of the automatic method applied has to be proven.