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Completed

NCT Number: NCT01231828

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Caen

Caen, 14033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-carnitine

Drug

L-carnitine 4g per day (4 bottles of 10ml).

Other names: Levocarnil.

Lactulose

Drug

Lactulose (30-60 ml per day)

Other names: Duphalac.

Primary outcomes

  1. Sleep latency during Maintenance of Wakefulness Test (MWT)

    Time frame: 40 min

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: AutoSop-Foie

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2010
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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