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

Narcolepsy Clinical Trial

— AUTOSOP  

Official title:

Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916253
• Other study ID #: CHUBX 2008/37
• Status: Completed
• Phase: N/A
• First received: May 29, 2009
• Last updated: April 24, 2013
• Start date: March 2010
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypersomnia
• Narcolepsy

Intervention

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).
• 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.

Locations

Country	Name	City	State
France	GENNPHASS - CHU de Bordeaux	Bordeaux
France	AP-HP - Hôpital de l'Hôtel-Dieu	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep latency during MWT, number of vehicle's line crossing on the road, standard deviation of the vehicle's position on the road		for each condition, at day 4 for patients or day 1 for healthy volonteers	No
Secondary	Subjective sleepiness (Karolinska and VAS scales)		for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers	No
Secondary	nocturnal sleep quality and quantity will be measured by PSG and Actimetry.		For each condition, at day 4 and 5 for patients or day 1 for healthy volonteers	No