Guidelines for the Recording and Evaluation of Pharmaco-Sleep Studies in Man: The International Pharmaco-EEG Society (IPEG)

Jobert, Marc; Wilson, Frederick J. F.; Roth, T.; Ruigt, G.S.F.; Anderer, P.; Drinkenburg, Wilhelmus

doi:10.1159/000343449

Cited by 40 publications

(28 citation statements)

References 528 publications

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“…Specific recommendations for pharmaco-PSG studies can be found in the ‘Guidelines for the recording and evaluation of pharmaco-sleep studies in man: the International Pharmaco-EEG Society' [24]. …”

Section: Resultsmentioning

confidence: 99%

“…Recommendations, specifically intended for pharmaco-sleep studies in man, for subject selection, environmental conditions and recording settings including adaptation nights as well as for digital recordings, calibration and biosignals, can be found in the ‘Guidelines for the recording and evaluation of pharmaco-sleep studies in man' recently published by the International Pharmaco-EEG Society [24]. …”

Section: Recordingmentioning

confidence: 99%

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Advanced Analysis of Pharmaco-Sleep Data in Humans

Anderer

2015

Neuropsychobiology

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Recordingmentioning

confidence: 99%

Advanced Analysis of Pharmaco-Sleep Data in Humans

Anderer

2015

Neuropsychobiology

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“…Secondly, it is essential to have an appropriate database at one's disposal to compare how variable the effects of a specific drug are within a drug class as well as over drug classes. To date, in contrast to clinical p-(sleep) EEG [98,99], there are no general recording or analysis principles in animal p-EEG and p-sleep EEG, which makes it difficult to compare drug effects between laboratories. Since most labs have already build up a consistent, homogeneous database of p-EEG effects it is a real challenge to define such principles, as most labs want to stick to their own standards.…”

Section: Methodological Standardisationmentioning

confidence: 99%

“… 1 Such guidelines are presently being prepared de novo as a follow-up to the IPEG human guidelines which have already appeared [98,99]: with this paper the IPEG would also like to invite people who think they can further contribute to the formulation of such guidelines to contact the first author. …”

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confidence: 99%

Pharmaco-EEG Studies in Animals: A History-Based Introduction to Contemporary Translational Applications

Drinkenburg

Ahnaou²,

Ruigt³

2015

Neuropsychobiology

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Current research on the effects of pharmacological agents on human neurophysiology finds its roots in animal research, which is also reflected in contemporary animal pharmaco-electroencephalography (p-EEG) applications. The contributions, present value and translational appreciation of animal p-EEG-based applications are strongly interlinked with progress in recording and neuroscience analysis methodology. After the pioneering years in the late 19th and early 20th century, animal p-EEG research flourished in the pharmaceutical industry in the early 1980s. However, around the turn of the millennium the emergence of structurally and functionally revealing imaging techniques and the increasing application of molecular biology caused a temporary reduction in the use of EEG as a window into the brain for the prediction of drug efficacy. Today, animal p-EEG is applied again for its biomarker potential - extensive databases of p-EEG and polysomnography studies in rats and mice hold EEG signatures of a broad collection of psychoactive reference and test compounds. A multitude of functional EEG measures has been investigated, ranging from simple spectral power and sleep-wake parameters to advanced neuronal connectivity and plasticity parameters. Compared to clinical p-EEG studies, where the level of vigilance can be well controlled, changes in sleep-waking behaviour are generally a prominent confounding variable in animal p-EEG studies and need to be dealt with. Contributions of rodent pharmaco-sleep EEG research are outlined to illustrate the value and limitations of such preclinical p-EEG data for pharmacodynamic and chronopharmacological drug profiling. Contemporary applications of p-EEG and pharmaco-sleep EEG recordings in animals provide a common and relatively inexpensive window into the functional brain early in the preclinical and clinical development of psychoactive drugs in comparison to other brain imaging techniques. They provide information on the impact of drugs on arousal and sleep architecture, assessing their neuropharmacological characteristics in vivo, including central exposure and information on kinetics. In view of the clear disadvantages as well as advantages of animal p-EEG as compared to clinical p-EEG, general statements about the usefulness of EEG as a biomarker to demonstrate the translatability of p-EEG effects should be made with caution, however, because they depend on the particular EEG or sleep parameter that is being studied. The contribution of animal p-EEG studies to the translational characterisation of centrally active drugs can be furthered by adherence to guidelines for methodological standardisation, which are presently under construction by the International Pharmaco-EEG Society (IPEG).

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“…Guidelines for the recording and evaluation of pharmaco-EEG studies and of pharmaco-sleep studies have been published in this journal in 2012 and 2013, respectively [14,15]. …”

mentioning

confidence: 99%