Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. (AutoSop-Foie)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. Impact of Lactulose and Carnitine Treatment.|
- Sleep latency during Maintenance of Wakefulness Test (MWT) [ Time Frame: 40 min ] [ Designated as safety issue: No ]
- Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG). [ Time Frame: 1 night ] [ Designated as safety issue: No ]
- Nocturnal sleep quality and quantity measured by Actimetry. [ Time Frame: during 3 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
L-carnitine 4g per day (4 bottles of 10ml).
Other Name: Levocarnil.
Lactulose (30-60 ml per day)
Other Name: Duphalac.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231828
|University Hospital of Caen|
|Caen, France, 14033|
|Principal Investigator:||Marie-Astrid PIQUET||University Hospital, Caen|
|Study Director:||Thong DAO||University Hospital, Caen|