NCT01231828

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

Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. Impact of Lactulose and Carnitine Treatment.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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, drivers supervision, virtual reality, pharmacology) among the "Réseau Eveil Sommeil Attention et Transports" (RESAT) network.

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 (2005 december 28th - Official Journal) 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 patients suffering from hepatic encephalopathy. Furthermore, even if therapeutic drugs significantly improve MWT scores there is no data available concerning the impact of these drugs on fitness to drive. Lactulose, a treatment of hepatic encephalopathy, has not been tested as a counter measure to driving impairment. 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 hepatic encephalopathy.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DRUG	L-carnitine	L-carnitine 4g per day (4 bottles of 10ml).
DRUG	Lactulose	Lactulose (30-60 ml per day)

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2010-11-01
• Last updated: 2013-02-27

Locations

1 site across 1 country: France