Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies

Not Applicable

Completed

• Conditions: Narcolepsy; Hypersomnia
• Interventions: Drug: Modafinil; Drug: Placebo

• Registration Number: NCT00916253
• Lead Sponsor: University Hospital, Bordeaux

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 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.

Study Timeline

• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-09
• Study Start: 2010-03
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Modafinil First	Placebo	Treatment by Modafinil during first condition then placebo during second condition
Placebo First	Placebo	Treatment by Placebo during first condition then Modafinil during second condition
Modafinil First	Modafinil	Treatment by Modafinil during first condition then placebo during second condition
Placebo First	Modafinil	Treatment by Placebo during first condition then Modafinil during second condition

Primary Outcome Measures

Name	Time	Method
Sleep latency during MWT, number of vehicle's line crossing on the road, standard deviation of the vehicle's position on the road	for each condition, at day 4 for patients or day 1 for healthy volonteers

Secondary Outcome Measures

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

Trial Locations

Locations (2)

GENNPHASS - CHU de Bordeaux; 🇫🇷 Bordeaux, France

AP-HP - Hôpital de l'Hôtel-Dieu; 🇫🇷 Paris, France