NarcolepsyAUTOSOPNCT00916253
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies
A study testing Modafinil in people with Narcolepsy and Hypersomnia, run by University Hospital, Bordeaux at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy, Hypersomnia
- What is being tested?
- Modafinil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
- 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.
Who cannot join
- 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,
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- pulmonary disorders,
- renal disorders,
- endocrinal disorders,
- having participated in a clinical study during the last 6 months,
- unable to drive.
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
GENNPHASS - CHU de Bordeaux
Bordeaux, 33076
AP-HP - Hôpital de l'Hôtel-Dieu
Paris, 75181
About this study
Official title: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment.
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
Read the 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.
- Conditions
- Narcolepsy, Hypersomnia
- Being tested
- Modafinil, Placebo
- Keywords
- Sleep, real driving, simulated driving, MWT
- Medical subject headings
- Narcolepsy, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
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).
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Modafinil First | Experimental | Treatment by Modafinil during first condition then placebo during second condition Receives: Drug: Modafinil; Drug: Placebo |
| Placebo First | Experimental | Treatment by Placebo during first condition then Modafinil during second condition Receives: Drug: Modafinil; Drug: Placebo |
| H | No intervention | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep latency during MWT, number of vehicle's line crossing on the road, standard deviation of the vehicle's position on the road
Measured: for each condition, at day 4 for patients or day 1 for healthy volonteers
Secondary outcomes (2)
Subjective sleepiness (Karolinska and VAS scales)
Measured: 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.
Measured: For each condition, at day 4 and 5 for patients or day 1 for healthy volonteers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre PHILIP, MD, PHD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916253
- Sponsor's protocol ID
- CHUBX 2008/37
- Other IDs
- 2009-011302-41, 2009
- Acronym
- AUTOSOP
- Status last verified
- Apr 2013
- First submitted
- 29 May 2009
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7792492Guilleminault 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.
PubMed 11420413Philip P, Mitler M. Sleepiness at the wheel: symptom or behavior? Sleep. 2000 Jun 15;23 Suppl 4:S119-21. No abstract available.
PubMed 10893083Findley LJ, Unverzagt ME, Suratt PM. Automobile accidents involving patients with obstructive sleep apnea. Am Rev Respir Dis. 1988 Aug;138(2):337-40. doi: 10.1164/ajrccm/138.2.337.
PubMed 3195832Sleep apnea, sleepiness, and driving risk. American Thoracic Society. Am J Respir Crit Care Med. 1994 Nov;150(5 Pt 1):1463-73. doi: 10.1164/ajrccm.150.5.7952578. No abstract available.
PubMed 7952578Barbe, Pericas J, Munoz A, Findley L, Anto JM, Agusti AG. Automobile accidents in patients with sleep apnea syndrome. An epidemiological and mechanistic study. Am J Respir Crit Care Med. 1998 Jul;158(1):18-22. doi: 10.1164/ajrccm.158.1.9709135.
PubMed 9655701Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104.
PubMed 10080847Lloberes P, Levy G, Descals C, Sampol G, Roca A, Sagales T, de la Calzada MD. Self-reported sleepiness while driving as a risk factor for traffic accidents in patients with obstructive sleep apnoea syndrome and in non-apnoeic snorers. Respir Med. 2000 Oct;94(10):971-6. doi: 10.1053/rmed.2000.0869.
PubMed 11059950Masa JF, Rubio M, Findley LJ. Habitually sleepy drivers have a high frequency of automobile crashes associated with respiratory disorders during sleep. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1407-12. doi: 10.1164/ajrccm.162.4.9907019.
PubMed 11029353Sagaspe 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.
PubMed 17425229George CF, Boudreau AC, Smiley A. Effects of nasal CPAP on simulated driving performance in patients with obstructive sleep apnoea. Thorax. 1997 Jul;52(7):648-53. doi: 10.1136/thx.52.7.648.
PubMed 9246139Poceta JS, Timms RM, Jeong DU, Ho SL, Erman MK, Mitler MM. Maintenance of wakefulness test in obstructive sleep apnea syndrome. Chest. 1992 Apr;101(4):893-7. doi: 10.1378/chest.101.4.893.
PubMed 1555458Mitler 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.
PubMed 9743270Meurice JC, Marc I, Series F. Efficacy of auto-CPAP in the treatment of obstructive sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med. 1996 Feb;153(2):794-8. doi: 10.1164/ajrccm.153.2.8564134.
PubMed 8564134Tiihonen M, Partinen M. Polysomnography and maintenance of wakefulness test as predictors of CPAP effectiveness in obstructive sleep apnea. Electroencephalogr Clin Neurophysiol. 1998 Dec;107(6):383-6. doi: 10.1016/s0013-4694(98)00079-0.
PubMed 9922082
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment.
- ClinicalTrials.gov ID
- NCT00916253
- Acronym / sponsor ID
- AUTOSOP / CHUBX 2008/37
- Conditions
- Narcolepsy, Hypersomnia
- Keywords
- Sleep, real driving, simulated driving, MWT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Modafinil First | Experimental | Drug: Modafinil, Drug: PlaceboTreatment by Modafinil during first condition then placebo during second condition |
| Placebo First | Experimental | Drug: Modafinil, Drug: PlaceboTreatment by Placebo during first condition then Modafinil during second condition |
| H | No intervention | –Healthy Volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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,
Key exclusion criteria (20 listed)
- Night workers,
- breast-feeding or pregnant women
- Beck's scale score < 8,
- neurologic disease,
- cardiovascular disorders including cardiac arrhythmia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModafinilModafinil 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 | Modafinil First, Placebo First |
| PlaceboPlacebo 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. | Drug | Modafinil First, Placebo First |
Primary outcome
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
2 secondary outcomes
Subjective sleepiness (Karolinska and VAS scales)
Time frame: 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.
Time frame: For each condition, at day 4 and 5 for patients or day 1 for healthy volonteers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 7792492Reyner 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.
- Background: PubMed 11420413Guilleminault 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.
- Background: PubMed 10893083Philip P, Mitler M. Sleepiness at the wheel: symptom or behavior? Sleep. 2000 Jun 15;23 Suppl 4:S119-21. No abstract available.
- Background: PubMed 3195832Findley LJ, Unverzagt ME, Suratt PM. Automobile accidents involving patients with obstructive sleep apnea. Am Rev Respir Dis. 1988 Aug;138(2):337-40. doi: 10.1164/ajrccm/138.2.337.
- Background: PubMed 7952578Sleep apnea, sleepiness, and driving risk. American Thoracic Society. Am J Respir Crit Care Med. 1994 Nov;150(5 Pt 1):1463-73. doi: 10.1164/ajrccm.150.5.7952578. No abstract available.
- Background: PubMed 9655701Barbe, Pericas J, Munoz A, Findley L, Anto JM, Agusti AG. Automobile accidents in patients with sleep apnea syndrome. An epidemiological and mechanistic study. Am J Respir Crit Care Med. 1998 Jul;158(1):18-22. doi: 10.1164/ajrccm.158.1.9709135.
- Background: PubMed 10080847Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104.
- Background: PubMed 11059950Lloberes P, Levy G, Descals C, Sampol G, Roca A, Sagales T, de la Calzada MD. Self-reported sleepiness while driving as a risk factor for traffic accidents in patients with obstructive sleep apnoea syndrome and in non-apnoeic snorers. Respir Med. 2000 Oct;94(10):971-6. doi: 10.1053/rmed.2000.0869.
- Background: PubMed 11029353Masa JF, Rubio M, Findley LJ. Habitually sleepy drivers have a high frequency of automobile crashes associated with respiratory disorders during sleep. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1407-12. doi: 10.1164/ajrccm.162.4.9907019.
- Background: PubMed 17425229Sagaspe 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.
- Background: PubMed 9246139George CF, Boudreau AC, Smiley A. Effects of nasal CPAP on simulated driving performance in patients with obstructive sleep apnoea. Thorax. 1997 Jul;52(7):648-53. doi: 10.1136/thx.52.7.648.
- Background: PubMed 1555458Poceta JS, Timms RM, Jeong DU, Ho SL, Erman MK, Mitler MM. Maintenance of wakefulness test in obstructive sleep apnea syndrome. Chest. 1992 Apr;101(4):893-7. doi: 10.1378/chest.101.4.893.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre PHILIP, MD, PHD principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modafinil in people with Narcolepsy and Hypersomnia, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00916253, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.