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

Primary Purpose

Narcolepsy, Hypersomnia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Modafinil

Placebo

About this trial

This is an interventional diagnostic trial for Narcolepsy focused on measuring Sleep, real driving, simulated driving, MWT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GENNPHASS - CHU de Bordeaux
AP-HP - Hôpital de l'Hôtel-Dieu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Modafinil First

Placebo First

Arm Description

Treatment by Modafinil during first condition then placebo during second condition

Treatment by Placebo during first condition then Modafinil during second condition

Healthy Volunteers

Outcomes

Primary Outcome Measures

Sleep latency during MWT, number of vehicle's line crossing on the road, standard deviation of the vehicle's position on the road

Secondary Outcome Measures

Subjective sleepiness (Karolinska and VAS scales)

nocturnal sleep quality and quantity will be measured by PSG and Actimetry.

Full Information

NCT ID

NCT00916253

First Posted

May 29, 2009

Last Updated

April 24, 2013

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT00916253

Brief Title

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

Acronym

AUTOSOP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Narcolepsy, Hypersomnia

Keywords

Sleep, real driving, simulated driving, MWT

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Modafinil First

Arm Type

Experimental

Arm Description

Treatment by Modafinil during first condition then placebo during second condition

Arm Title

Placebo First

Arm Type

Experimental

Arm Description

Treatment by Placebo during first condition then Modafinil during second condition

Arm Title

Arm Type

No Intervention

Arm Description

Healthy Volunteers

Intervention Type

Drug

Intervention Name(s)

Modafinil

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Subjective sleepiness (Karolinska and VAS scales)

Time Frame

for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre PHILIP, MD, PHD

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Principal Investigator

Facility Information:

Facility Name

GENNPHASS - CHU de Bordeaux

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

AP-HP - Hôpital de l'Hôtel-Dieu

City

Paris

ZIP/Postal Code

75181

Country

France

12. IPD Sharing Statement

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

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