title: Comparing Treatment Effect Measurements in Narcolepsy: The Sustained Attention to Response Task, Epworth Sleepiness Scale and Maintenance of Wakefulness Test.
abstract: OBJECTIVE
  To validate the Sustained Attention to Response Task (SART) as a treatment effect measure in narcolepsy, and to compare the SART with the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS).
  
  
  METHODS
  Validation of treatment effect measurements within a randomized controlled trial (RCT).
  
  
  METHODS
  Ninety-five patients with narcolepsy with or without cataplexy.
  
  
  METHODS
  The RCT comprised a double-blind, parallel-group, multicenter trial comparing the effects of 8-w treatments with pitolisant (BF2.649), modafinil, or placebo (NCT01067222). MWT, ESS, and SART were administered at baseline and after an 8-w treatment period. The severity of excessive daytime sleepiness and cataplexy was also assessed using the Clinical Global Impression scale (CGI-C).
  
  
  RESULTS
  The SART, MWT, and ESS all had good reliability, obtained for the SART and MWT using two to three sessions in 1 day. The ability to distinguish responders from nonresponders, classified using the CGI-C score, was high for all measures, with a high performance for the SART (r = 0.61) and the ESS (r = 0.54).
  
  
  CONCLUSIONS
  The Sustained Attention to Response Task is a valid and easy-to-administer measure to assess treatment effects in narcolepsy, enhanced by combining it with the Epworth Sleepiness Scale.
authors.affiliation: Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Astrid
authors.initials: A
authors.lastname: van der Heide
authors.affiliation: Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Mojca K M
authors.initials: MK
authors.lastname: van Schie
authors.affiliation: Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden, The Netherlands.|SleepWake Center SEIN, Heemstede, The Netherlands.
authors.forename: Gert Jan
authors.initials: GJ
authors.lastname: Lammers
authors.affiliation: Sleep Unit, Reference Center for Narcolepsy, Department of Neurology, Gui-de-Chauliac Hospital, University of Montpellier, Montpellier, France.
authors.forename: Yves
authors.initials: Y
authors.lastname: Dauvilliers
authors.affiliation: Sleep Disorder Unit, Pitié-Salpêtrière Hospital, Reference Center for Narcolepsy, and Pierre and Marie Curie University, Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Arnulf
authors.affiliation: Sleep Unit, Hephata Clinic, Schwalmstadt-Treysa, Germany.|Philipps University Marburg, Department of Neurology, Marburg, Germany.
authors.forename: Geert
authors.initials: G
authors.lastname: Mayer
authors.affiliation: Sleep Unit, Department of Neurology, University of Bern, Bern, Switzerland.
authors.forename: Claudio L
authors.initials: CL
authors.lastname: Bassetti
authors.affiliation: Bioprojet,Paris, France.
authors.forename: Claire-Li
authors.initials: CL
authors.lastname: Ding
authors.affiliation: University of Louvain, Faculty of Economics, Department of Statistics, Belgium.|University of Melbourne, Faculty of Medicine, Department of Statistics, Melbourne, Australia.
authors.forename: Philippe
authors.initials: P
authors.lastname: Lehert
authors.affiliation: Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: J Gert
authors.initials: JG
authors.lastname: van Dijk
mesh_terms: D000328:Adult; D001288:Attention / Q000187:drug effects*; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D002385:Cataplexy / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D000077408:Modafinil; D009290:Narcolepsy / Q000188:drug therapy* / Q000503:physiopathology* / Q000523:psychology; D010880:Piperidines / Q000627:therapeutic use*; D015203:Reproducibility of Results; D012894:Sleep Stages / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects*
chemical_list: D001559:Benzhydryl Compounds; D010880:Piperidines; C516975:pitolisant; D000077408:Modafinil
keywords: ESS; MWT; SART; narcolepsy; sleepiness; sustained attention; treatment effects; validation; vigilance