Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies
Condition: Narcolepsy; Hypersomnia
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence
Study type: Interventional

Summary: 
      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 research to better
      understand the difference between real and simulated driving
    

Detailed description: 
      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. Inclusion of healthy volunteers will
      allow to collect reference data about somnolence during MWT.
    

Intervention name(s): Modafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
during 3 days at home
during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day and 2 driving sessions (one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under treatment (Modafinil).; Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
during 3 days at home
during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day, and 2 driving sessions ( one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under Placebo.
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Sleep; real driving; simulated driving; MWT