Clinical Trial: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment.

Brief 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 Summary: 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.
Sponsor: University Hospital, Bordeaux

Current Primary Outcome: Sleep latency during MWT, number of vehicle's line crossing on the road, standard deviation of the vehicle's position on the road [ Time Frame: for each condition, at day 4 for patients or day 1 for healthy volonteers ]

Original Primary Outcome: Sleep latency during MWT, number of vehicle's line crossing on the road, standard deviation of the vehicle's position on the road [ Time Frame: for each condition, at day 4 ]

Current Secondary Outcome:

  • Subjective sleepiness (Karolinska and VAS scales) [ Time Frame: for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers ]
  • nocturnal sleep quality and quantity will be measured by PSG and Actimetry. [ Time Frame: For each condition, at day 4 and 5 for patients or day 1 for healthy volonteers ]


Original Secondary Outcome:

  • Subjective sleepiness (Karolinska and VAS scales) [ Time Frame: for each condition, at day 4 and 5 ]
  • nocturnal sleep quality and quantity will be measured by PSG and Actimetry. [ Time Frame: For each condition, at day 4 and 5 ]


Information By: University Hospital, Bordeaux

Dates:
Date Received: May 29, 2009
Date Started: March 2010
Date Completion:
Last Updated: April 24, 2013
Last Verified: April 2013