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Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies (AUTOSOP)

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ClinicalTrials.gov Identifier: NCT00916253
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : April 25, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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, driver's supervision, virtual reality, pharmacology) among the RESAT network (Réseau Eveil Sommeil Attention Transport). It will stimulate data acquisition in technological research to better understand the difference between real and simulated driving

Condition or disease Intervention/treatment Phase
Narcolepsy Hypersomnia Drug: Modafinil Drug: Placebo 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 (arrêté du 28 décembre 2005 du journal officiel) 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 narcoleptics and hypersomniacs. Furthermore, even if alerting drugs significantly improve MWT scores there is no data available concerning the impact of these drugs on fitness to drive. 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 narcolepsy and hypersomnia. Inclusion of healthy volunteers will allow to collect reference data about somnolence during MWT.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment.
Study Start Date : March 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Modafinil First
Treatment by Modafinil during first condition then placebo during second condition
 Drug: Modafinil

Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):

  • during 3 days at home
  • during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day and 2 driving sessions (one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under treatment (Modafinil).
Drug: Placebo

Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):

  • during 3 days at home
  • during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day, and 2 driving sessions ( one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under Placebo.
Experimental: Placebo First
Treatment by Placebo during first condition then Modafinil during second condition
 Drug: Modafinil

Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):

  • during 3 days at home
  • during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day and 2 driving sessions (one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under treatment (Modafinil).
Drug: Placebo

Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):

  • during 3 days at home
  • during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day, and 2 driving sessions ( one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under Placebo.
No Intervention: H
Healthy Volunteers


Outcome Measures
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Primary Outcome Measures :
  1. Sleep latency during MWT, number of vehicle's line crossing on the road, standard deviation of the vehicle's position on the road [ Time Frame: for each condition, at day 4 for patients or day 1 for healthy volonteers ]

Secondary Outcome Measures :
  1. Subjective sleepiness (Karolinska and VAS scales) [ Time Frame: for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers ]
  2. nocturnal sleep quality and quantity will be measured by PSG and Actimetry. [ Time Frame: For each condition, at day 4 and 5 for patients or day 1 for healthy volonteers ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Patients:

  • Narcoleptic patients with or without cataplexy or hypersomniacs
  • aged from 18 to 65 years,
  • treated for attacks of cataplexy,
  • treated with a maximum dose of Modiodal: 400 mg per day (4 tablets of 100mg),
  • without any other disease which could be responsible of excessive daytime sleepiness,
  • having their driver's licence,
  • driving more than 5000 Km/year,
  • registered to French national health and pensions organization,
  • having regular timetables of life 7 days before beginning the study,
  • having given their written light agreement in order to participate in the study.

Inclusion Criteria for Healthy Volunteers:

  • without any sleep disorders,
  • having their driver's licence since at least 2 years,
  • driving more than 5000 Km/year,
  • registered to French national health and pensions organization,
  • having regular timetables of life 7 days before beginning the study,
  • having given their written light agreement in order to participate in the study.

Exclusion Criteria for Patients:

  • Night workers,
  • breast-feeding or pregnant women
  • Beck's scale score < 8,
  • neurologic disease,
  • cardiovascular disorders including cardiac arrhythmia,
  • sleep disorders except narcolepsy and hypersomnia,
  • pulmonary disorders,
  • renal disorders,
  • endocrinal disorders,
  • having participated in a clinical study during the last 6 months,
  • unable to drive.

Exclusion Criteria for Healthy Volunteers:

  • Night workers,
  • neurologic disease,
  • cardiovascular disorders,
  • sleep disorders,
  • pulmonary disorders,
  • renal disorders,
  • endocrinal disorders,
  • having participated in a clinical study during the last 6 months,
  • unable to drive.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00916253


Locations
France
GENNPHASS - CHU de Bordeaux
Bordeaux, France, 33076
AP-HP - Hôpital de l'Hôtel-Dieu
Paris, France, 75181
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Pierre PHILIP, MD, PHD University Hospital, Bordeaux
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00916253     History of Changes
Other Study ID Numbers: CHUBX 2008/37
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: April 25, 2013
Last Verified: April 2013

Keywords provided by University Hospital, Bordeaux:
Sleep
real driving
simulated driving
MWT

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Modafinil
 Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs