Clinical trial NCT01231828: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.
Official title: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. Impact of Lactulose and Carnitine Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: sleep
cirrhosis
encephalopathy
simulated driving
sleep disorders
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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, 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.

Eligibility criteria: Inclusion Criteria:

* Cirrhosis proved by histologic or clinico-biologics criteria, whatever its severity, its stability defined by a child stable score (variation \< 2 points for the last month) without any other disease which could be responsible of excessive daytime sleepiness
* driver's licence since at least 2 years
* driving more than 2000 Km/year
* registered to French national health and pensions organization
* having given their written light agreement in order to participate in the study.

Exclusion Criteria:

* Night workers
* neurologic disease
* recent strong complication (\< 30 days)
* recent antibiotics or lactulose intake
* substance abusers (alcohol)
* hepatoma more than 5 cm
* disorder associated which engaged life prognostic in a short time
* glycemia fasted \> 8 mmol/l
* haemoglobin \< 10g/l
* neurologic or psychiatric disorders associated which affect superiors functions,
* hepatic encephalopathy stage 3 or 4
* having participated in a clinical study during the last 6 months
* drugs abusers
* unable to drive.

Primary outcomes:
measure: Sleep latency during Maintenance of Wakefulness Test (MWT)
timeFrame: 40 min
Secondary outcomes:
measure: Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG).
timeFrame: 1 night
measure: Nocturnal sleep quality and quantity measured by Actimetry.
timeFrame: during 3 days
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital of Caen
Study officials:
affiliation: University Hospital, Caen
name: Marie-Astrid PIQUET
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Thong DAO
role: STUDY_DIRECTOR
References: