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The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, driver's supervision, virtual reality, pharmacology) among the RESAT network (Réseau Eveil Sommeil Attention Transport). It will stimulate data acquisition in technological reseach to better understand the difference between real and simulated driving
Excessive daytime sleepiness is responsible of 20% of traffic accidents and 2/3 of truck accidents on French Freeways. Since the publication of a new law (arrêté du 28 décembre 2005 du journal officiel) regulating fitness to drive, the Maintenance of Wakefulness Test (MWT) is now mandatory to evaluate driving skills of patients suffering of excessive daytime sleepiness. The MWT has shown a good predictability of driving handicap on simulators in patients suffering from obstructive sleep apnea syndrome. Nevertheless no study has proven yet the predictability of the MWT regarding real and simulated driving in narcoleptics and hypersomniacs. Furthermore, even if alerting drugs significantly improve MWT scores there is no data available concerning the impact of these drugs on fitness to drive. This lack of knowledge is a major handicap to evaluate driving skills of treated patients suffering from excessive daytime sleepiness. The main objective of our project is to test the predictive value of the MWT on real and simulated driving performances in untreated and treated sleepy patients suffering from narcolepsy and hypersomnia.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
GENNPHASS - CHU de Bordeaux
Not yet recruiting
University Hospital, Bordeaux
Published on BioPortfolio: 2014-07-23T21:14:16-0400
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be...
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This Phase 2 study is a 3-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil...
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A condition characterized by recurrent episodes of daytime somnolence and lapses in consciousness (microsomnias) that may be associated with automatic behaviors and AMNESIA. CATAPLEXY; SLEEP PARALYSIS, and hypnagogic HALLUCINATIONS frequently accompany narcolepsy. The pathophysiology of this disorder includes sleep-onset rapid eye movement (REM) sleep, which normally follows stage III or IV sleep. (From Neurology 1998 Feb;50(2 Suppl 1):S2-S7)
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
A central nervous system stimulant used most commonly in the treatment of attention-deficit disorders in children and for narcolepsy. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE.
Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. There is a weak association between the presence of the HLA-B7 antigen and the diseases of narcolepsy and idiopathic hemochromatosis. HLA-B7 is in linkage disequilibrium with HLA-A3 and HLA-DR2.
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