title: Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial.
abstract: OBJECTIVE
  Patients with excessive daytime sleepiness (EDS) are at high risk for driving accidents, and physicians are concerned by the effect of alerting drugs on driving skills of sleepy patients. No study has up to now investigated the effect of modafinil (a reference drug to treat EDS in patients with hypersomnia) on on-road driving performance of patients suffering from central hypersomnia. The objective is to evaluate in patients with central hypersomnia the effect of a wake-promoting drug on real driving performance and to assess the relationship between objective sleepiness and driving performance.
  
  
  METHODS
  Randomized, crossover, double-blind placebo-controlled trial conducted among 13 patients with narcolepsy and 14 patients with idiopathic hypersomnia. Patients were randomly assigned to receive modafinil (400 mg) or placebo for 5 days prior to the driving test. Each condition was separated by at least 3 weeks of washout.
  
  
  METHODS
  Mean number of Inappropriate Line Crossings, Standard Deviation of Lateral Position of the vehicle and mean sleep latency in the Maintenance of Wakefulness Test were assessed.
  
  
  RESULTS
  Modafinil reduced the mean number of Inappropriate Line Crossings and Standard Deviation of Lateral Position of the vehicle compared to placebo (F(1,25) = 4.88, P < 0.05 and F(1,25) = 3.87, P = 0.06 tendency). Mean sleep latency at the Maintenance of Wakefulness Test significantly correlated with the mean number of Inappropriate Line Crossings (r = -0.41, P < 0.001).
  
  
  CONCLUSIONS
  Modafinil improves driving performance in patients with narcolepsy and idiopathic hypersomnia. The Maintenance of Wakefulness Test is a suitable clinical tool to assess fitness to drive in this population.
authors.affiliation: Université de Bordeaux, Sommeil, Attention et Neuropsychiatrie, USR 3413, Bordeaux, France ; CNRS, SANPSY, USR 3413, Bordeaux, France ; CHU Bordeaux, Centre Hypersomnies Rares, Bordeaux, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Philip
authors.affiliation: Université de Bordeaux, Sommeil, Attention et Neuropsychiatrie, USR 3413, Bordeaux, France ; CNRS, SANPSY, USR 3413, Bordeaux, France ; CHU Bordeaux, Centre Hypersomnies Rares, Bordeaux, France.
authors.forename: Cyril
authors.initials: C
authors.lastname: Chaufton
authors.affiliation: Université de Bordeaux, Sommeil, Attention et Neuropsychiatrie, USR 3413, Bordeaux, France ; CNRS, SANPSY, USR 3413, Bordeaux, France ; CHU Bordeaux, Centre Hypersomnies Rares, Bordeaux, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Taillard
authors.affiliation: Université de Bordeaux, Sommeil, Attention et Neuropsychiatrie, USR 3413, Bordeaux, France ; CNRS, SANPSY, USR 3413, Bordeaux, France.
authors.forename: Aurore
authors.initials: A
authors.lastname: Capelli
authors.affiliation: CHU Bordeaux, Centre Hypersomnies Rares, Bordeaux, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Coste
authors.affiliation: Université Paris Descartes, APHP, Hôtel Dieu de Paris, Centre du Sommeil et de la Vigilance, Centre Hypersomnies Rares, Paris, France.
authors.forename: Damien
authors.initials: D
authors.lastname: Léger
authors.affiliation: Département de Pharmacologie, Université de Bordeaux, Bordeaux, France ; INSERM CIC-P0005, Bordeaux, France ; INSERM U657, Bordeaux, France.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Moore
authors.affiliation: Université de Bordeaux, Sommeil, Attention et Neuropsychiatrie, USR 3413, Bordeaux, France ; CNRS, SANPSY, USR 3413, Bordeaux, France ; CHU Bordeaux, Centre Hypersomnies Rares, Bordeaux, France.
authors.forename: Patricia
authors.initials: P
authors.lastname: Sagaspe
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001334:Automobile Driving / Q000523:psychology*; D001559:Benzhydryl Compounds / Q000494:pharmacology* / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020177:Idiopathic Hypersomnia / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009290:Narcolepsy / Q000188:drug therapy* / Q000503:physiopathology; D012894:Sleep Stages / Q000187:drug effects / Q000502:physiology; D014851:Wakefulness / Q000187:drug effects; D055815:Young Adult
chemical_list: D001559:Benzhydryl Compounds; D000077408:Modafinil
keywords: Automobile driving; MWT; idiopathic hypersomnia; modafinil; narcolepsy; sleepiness