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

What Was Tested

The trial (not phased) is built around L-Carnitine.

It will give for the first time an indication on the impact of alerting treatments on driving risks.

It had two arms (groups): Carnitine (experimental) and Lactulose (experimental).

Versus placebo.

Versus placebo.

The registry classes the interventions as drug.

More on the Plan

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.

Nevertheless no study has proven yet the predictability of the MWT regarding real and simulated driving in patients suffering from hepatic encephalopathy.

Lactulose, a treatment of hepatic encephalopathy, has not been tested as a counter measure to driving impairment.

The main objective of their 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 Took Part

55 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: night workers; neurologic disease; recent strong complication (\< 30 days).

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both L-Carnitine and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-09 with completion listed for 2012-06.

It ran at 1 site in France.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Sleep latency during Maintenance of Wakefulness Test (MWT) (time frame: 40 min).

It also tracked 2 secondary outcomes, for example Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG) and Nocturnal sleep quality and quantity measured by Actimetry.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 55 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.