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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carnitine | Experimental | Versus placebo. |
|
| Lactulose | Experimental | Versus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-carnitine | Drug | L-carnitine 4g per day (4 bottles of 10ml). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep latency during Maintenance of Wakefulness Test (MWT) | 40 min |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG). | 1 night | |
| Nocturnal sleep quality and quantity measured by Actimetry. | during 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Astrid PIQUET | University Hospital, Caen | Principal Investigator |
| Thong DAO | University Hospital, Caen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Caen | Caen | 14033 | France |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D001927 | Brain Diseases |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Lactulose | Drug | Lactulose (30-60 ml per day) |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |
| D004187 |
| Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |