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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011302-41 | EudraCT Number |
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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, 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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modafinil First | Experimental | Treatment by Modafinil during first condition then placebo during second condition |
|
| Placebo First | Experimental | Treatment by Placebo during first condition then Modafinil during second condition |
|
| H | No Intervention | Healthy Volunteers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective sleepiness (Karolinska and VAS scales) | for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers | |
| 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 |
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Inclusion Criteria for Patients:
Inclusion Criteria for Healthy Volunteers:
Exclusion Criteria for Patients:
Exclusion Criteria for Healthy Volunteers:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre PHILIP, MD, PHD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GENNPHASS - CHU de Bordeaux | Bordeaux | 33076 | France | |||
| AP-HP - Hôpital de l'Hôtel-Dieu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7792492 | Background | Reyner LA, Horne JA, Reyner A. Gender- and age-related differences in sleep determined by home-recorded sleep logs and actimetry from 400 adults. Sleep. 1995 Feb;18(2):127-34. | |
| 11420413 | Background | Guilleminault C, Pelayo R, Leger D, Philip P, Ohayon M. Sleep-disordered breathing and upper-airway anomalies in first-degree relatives of ALTE children. Pediatr Res. 2001 Jul;50(1):14-22. doi: 10.1203/00006450-200107000-00006. |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Placebo | Drug | Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
|
|
| Paris |
| 75181 |
| France |
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| 17425229 | Background | Sagaspe P, Taillard J, Chaumet G, Guilleminault C, Coste O, Moore N, Bioulac B, Philip P. Maintenance of wakefulness test as a predictor of driving performance in patients with untreated obstructive sleep apnea. Sleep. 2007 Mar;30(3):327-30. |
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| 9743270 | Background | Mitler MM, Walsleben J, Sangal RB, Hirshkowitz M. Sleep latency on the maintenance of wakefulness test (MWT) for 530 patients with narcolepsy while free of psychoactive drugs. Electroencephalogr Clin Neurophysiol. 1998 Jul;107(1):33-8. doi: 10.1016/s0013-4694(98)00044-3. |
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| 24587570 | Result | Philip P, Chaufton C, Taillard J, Capelli A, Coste O, Leger D, Moore N, Sagaspe P. Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial. Sleep. 2014 Mar 1;37(3):483-7. doi: 10.5665/sleep.3480. |
| D001523 |
| Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |