Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial.
SLEEP. 2014-03-01; :
DOI: 10.5665/sleep.3480
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1. Sleep. 2014 Mar 1;37(3):483-7. doi: 10.5665/sleep.3480.
Modafinil improves real driving performance in patients with hypersomnia: a
randomized double-blind placebo-controlled crossover clinical trial.
Philip P(1), Chaufton C(1), Taillard J(1), Capelli A(2), Coste O(3), Léger D(4),
Moore N(5), Sagaspe P(1).
Author information:
(1)Université de Bordeaux, Sommeil, Attention et Neuropsychiatrie, USR 3413,
Bordeaux, France ; CNRS, SANPSY, USR 3413, Bordeaux, France ; CHU Bordeaux,
Centre Hypersomnies Rares, Bordeaux, France.
(2)Université de Bordeaux, Sommeil, Attention et Neuropsychiatrie, USR 3413,
Bordeaux, France ; CNRS, SANPSY, USR 3413, Bordeaux, France.
(3)CHU Bordeaux, Centre Hypersomnies Rares, Bordeaux, France.
(4)Université Paris Descartes, APHP, Hôtel Dieu de Paris, Centre du Sommeil et de
la Vigilance, Centre Hypersomnies Rares, Paris, France.
(5)Département de Pharmacologie, Université de Bordeaux, Bordeaux, France ;
INSERM CIC-P0005, Bordeaux, France ; INSERM U657, Bordeaux, France.
STUDY 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.
DESIGN AND PARTICIPANTS: 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.
MEASUREMENTS: 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.
DOI: 10.5665/sleep.3480
PMCID: PMC3920313
PMID: 24587570 [Indexed for MEDLINE]