title: Guidelines for the recording and evaluation of pharmaco-sleep studies in man: the International Pharmaco-EEG Society (IPEG).
abstract: The International Pharmaco-EEG Society (IPEG) presents guidelines summarising the requirements for the recording and computerised evaluation of pharmaco-sleep data in man. Over the past years, technical and data-processing methods have advanced steadily, thus enhancing data quality and expanding the palette of sleep assessment tools that can be used to investigate the activity of drugs on the central nervous system (CNS), determine the time course of effects and pharmacodynamic properties of novel therapeutics, hence enabling the study of the pharmacokinetic/pharmacodynamic relationship, and evaluate the CNS penetration or toxicity of compounds. However, despite the presence of robust guidelines on the scoring of polysomnography -recordings, a review of the literature reveals inconsistent -aspects in the operating procedures from one study to another. While this fact does not invalidate results, the lack of standardisation constitutes a regrettable shortcoming, especially in the context of drug development programmes. The present guidelines are intended to assist investigators, who are using pharmaco-sleep measures in clinical research, in an effort to provide clear and concise recommendations and thereby to standardise methodology and facilitate comparability of data across laboratories.
authors.affiliation: International Pharmaco-EEG Society, Berlin, Germany. publications@IPEG-society.org
authors.forename: Marc
authors.initials: M
authors.lastname: Jobert
authors.forename: Frederick J
authors.initials: FJ
authors.lastname: Wilson
authors.forename: Thomas
authors.initials: T
authors.lastname: Roth
authors.forename: Gé S F
authors.initials: GS
authors.lastname: Ruigt
authors.forename: Peter
authors.initials: P
authors.lastname: Anderer
authors.forename: Wilhelmus H I M
authors.initials: WH
authors.lastname: Drinkenburg
authors.forename: Frederik W
authors.initials: FW
authors.lastname: Bes
authors.forename: Martin
authors.initials: M
authors.lastname: Brunovsky
authors.forename: Heidi
authors.initials: H
authors.lastname: Danker-Hopfe
authors.forename: Jon
authors.initials: J
authors.lastname: Freeman
authors.forename: Joop M A
authors.initials: JM
authors.lastname: van Gerven
authors.forename: Georg
authors.initials: G
authors.lastname: Gruber
authors.forename: Bob
authors.initials: B
authors.lastname: Kemp
authors.forename: Gerhard
authors.initials: G
authors.lastname: Klösch
authors.forename: Junshui
authors.initials: J
authors.lastname: Ma
authors.forename: Thomas
authors.initials: T
authors.lastname: Penzel
authors.forename: Barry T
authors.initials: BT
authors.lastname: Peterson
authors.forename: Hartmut
authors.initials: H
authors.lastname: Schulz
authors.forename: Luc
authors.initials: L
authors.lastname: Staner
authors.forename: Bernd
authors.initials: B
authors.lastname: Saletu
authors.forename: Vladimir
authors.initials: V
authors.lastname: Svetnik
mesh_terms: D004569:Electroencephalography / Q000592:standards*; D006801:Humans; D010601:Pharmacology, Clinical / Q000379:methods / Q000592:standards*; D017286:Polysomnography / Q000592:standards*; D017410:Practice Guidelines as Topic / Q000592:standards*; D012890:Sleep / Q000187:drug effects*; D012955:Societies, Medical / Q000592:standards*