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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01231828
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : February 27, 2013
Information provided by (Responsible Party):
University Hospital, Caen

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.

Condition or disease Intervention/treatment Phase
Cirrhosis Drug: L-carnitine Drug: Lactulose Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : September 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Sleep latency during Maintenance of Wakefulness Test (MWT) [ Time Frame: 40 min ]

Secondary Outcome Measures :
  1. Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG). [ Time Frame: 1 night ]
  2. Nocturnal sleep quality and quantity measured by Actimetry. [ Time Frame: during 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01231828

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University Hospital of Caen
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
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Principal Investigator: Marie-Astrid PIQUET University Hospital, Caen
Study Director: Thong DAO University Hospital, Caen
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Responsible Party: University Hospital, Caen Identifier: NCT01231828    
Other Study ID Numbers: A90591-34
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013
Keywords provided by University Hospital, Caen:
simulated driving
sleep disorders
Additional relevant MeSH terms:
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Pathologic Processes
Gastrointestinal Agents