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Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. (AutoSop-Foie)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01231828
First received: October 4, 2010
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Cirrhosis
 Drug: L-carnitine
Drug: Lactulose

Study Type: Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Sleep latency during Maintenance of Wakefulness Test (MWT) [ Time Frame: 40 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carnitine
Versus placebo.
 Drug: L-carnitine
L-carnitine 4g per day (4 bottles of 10ml).
Other Name: Levocarnil.
Experimental: Lactulose
Versus placebo
 Drug: Lactulose
Lactulose (30-60 ml per day)
Other Name: Duphalac.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231828

Locations
France
University Hospital of Caen
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Marie-Astrid PIQUET University Hospital, Caen
Study Director: Thong DAO University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01231828     History of Changes
Other Study ID Numbers: A90591-34
Study First Received: October 4, 2010
Last Updated: February 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
sleep
cirrhosis
encephalopathy
simulated driving
sleep disorders

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Stress, Psychological
Liver Diseases
Digestive System Diseases
Pathologic Processes
Behavioral Symptoms
Carnitine
Lactulose
 Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013