Astrid van der Heide1, Mojca K M van Schie1, Gert Jan Lammers1,2, Yves Dauvilliers3, Isabelle Arnulf4, Geert Mayer5,6, Claudio L Bassetti7, Claire-Li Ding8, Philippe Lehert9,10, J Gert van Dijk1. 1. Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden, The Netherlands. 2. SleepWake Center SEIN, Heemstede, The Netherlands. 3. Sleep Unit, Reference Center for Narcolepsy, Department of Neurology, Gui-de-Chauliac Hospital, University of Montpellier, Montpellier, France. 4. Sleep Disorder Unit, Pitié-Salpêtrière Hospital, Reference Center for Narcolepsy, and Pierre and Marie Curie University, Paris, France. 5. Sleep Unit, Hephata Clinic, Schwalmstadt-Treysa, Germany. 6. Philipps University Marburg, Department of Neurology, Marburg, Germany. 7. Sleep Unit, Department of Neurology, University of Bern, Bern, Switzerland. 8. Bioprojet,Paris, France. 9. University of Louvain, Faculty of Economics, Department of Statistics, Belgium. 10. University of Melbourne, Faculty of Medicine, Department of Statistics, Melbourne, Australia.
Abstract
STUDY OBJECTIVES: 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). DESIGN: Validation of treatment effect measurements within a randomized controlled trial (RCT). PATIENTS: Ninety-five patients with narcolepsy with or without cataplexy. INTERVENTIONS: 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). MEASUREMENTS AND 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.
RCT Entities:
STUDY OBJECTIVES: 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). DESIGN: Validation of treatment effect measurements within a randomized controlled trial (RCT). PATIENTS: Ninety-five patients with narcolepsy with or without cataplexy. INTERVENTIONS: 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). MEASUREMENTS AND 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: Mojca K M Van Schie; Roland D Thijs; Rolf Fronczek; Huub A M Middelkoop; Gert Jan Lammers; J Gert Van Dijk Journal: J Sleep Res Date: 2011-11-19 Impact factor: 3.981
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