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

NCT00916253 | Completed

• 2 other identifiers: CHUBX 2008/372009-011302-41
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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

Conditions

Narcolepsy; Hypersomnia

Keywords

Sleep; real driving; simulated driving; MWT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (3)

Modafinil First

EXPERIMENTAL

Treatment by Modafinil during first condition then placebo during second condition

Drug: Modafinil; Drug: Placebo

Placebo First

EXPERIMENTAL

Treatment by Placebo during first condition then Modafinil during second condition

Drug: Modafinil; Drug: Placebo

H

NO INTERVENTION

Healthy Volunteers

Interventions

Modafinil DRUG

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).

Modafinil First; Placebo First

Placebo DRUG

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.

Modafinil First; Placebo First

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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,

You may not qualify if:

• 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.
• Night workers,
• neurologic disease,
• cardiovascular disorders,
• sleep disorders,

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

GENNPHASS - CHU de Bordeaux

Bordeaux, 33076, France

Location

AP-HP - Hôpital de l'Hôtel-Dieu

Paris, 75181, France

Location

Related Publications (32)

• 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.

  PMID: 7792492 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.

  PMID: 11420413 BACKGROUND

• Philip P, Mitler M. Sleepiness at the wheel: symptom or behavior? Sleep. 2000 Jun 15;23 Suppl 4:S119-21. No abstract available.

  PMID: 10893083 BACKGROUND

• Findley 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.

  PMID: 3195832 BACKGROUND

• Sleep 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.

  PMID: 7952578 BACKGROUND

• Barbe, 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.

  PMID: 9655701 BACKGROUND

• Teran-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.

  PMID: 10080847 BACKGROUND

• Lloberes 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.

  PMID: 11059950 BACKGROUND

• Masa 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.

  PMID: 11029353 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.

  PMID: 17425229 BACKGROUND

• George 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.

  PMID: 9246139 BACKGROUND

• Poceta 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.

  PMID: 1555458 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.

  PMID: 9743270 BACKGROUND

• Meurice 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.

  PMID: 8564134 BACKGROUND

• Tiihonen 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.

  PMID: 9922082 BACKGROUND

• Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy. US Modafinil in Narcolepsy Multicenter Study Group. Ann Neurol. 1998 Jan;43(1):88-97. doi: 10.1002/ana.410430115.

  PMID: 9450772 BACKGROUND

• Findley LJ, Suratt PM, Dinges DF. Time-on-task decrements in "steer clear" performance of patients with sleep apnea and narcolepsy. Sleep. 1999 Sep 15;22(6):804-9. doi: 10.1093/sleep/22.6.804.

  PMID: 10505827 BACKGROUND

• Findley L, Unverzagt M, Guchu R, Fabrizio M, Buckner J, Suratt P. Vigilance and automobile accidents in patients with sleep apnea or narcolepsy. Chest. 1995 Sep;108(3):619-24. doi: 10.1378/chest.108.3.619.

  PMID: 7656606 BACKGROUND

• Grubb TC. Narcolepsy and highway accidents. JAMA. 1969 Sep 15;209(11):1720. No abstract available.

  PMID: 5820175 BACKGROUND

• Bartels EC, Kusakcioglu O. Narcolepsy: a possible cause of automobile accidents. Lahey Clin Found Bull. 1965;14(1):21-6. No abstract available.

  PMID: 5828637 BACKGROUND

• Aldrich MS. Automobile accidents in patients with sleep disorders. Sleep. 1989 Dec;12(6):487-94. doi: 10.1093/sleep/12.6.487.

  PMID: 2595172 BACKGROUND

• O'Hanlon JF, Volkerts ER. Hypnotics and actual driving performance. Acta Psychiatr Scand Suppl. 1986;332:95-104. doi: 10.1111/j.1600-0447.1986.tb08985.x.

  PMID: 3554901 BACKGROUND

• Ramaekers JG, O'Hanlon JF. Acrivastine, terfenadine and diphenhydramine effects on driving performance as a function of dose and time after dosing. Eur J Clin Pharmacol. 1994;47(3):261-6. doi: 10.1007/BF02570506.

  PMID: 7867679 BACKGROUND

• Philip P, Sagaspe P, Moore N, Taillard J, Charles A, Guilleminault C, Bioulac B. Fatigue, sleep restriction and driving performance. Accid Anal Prev. 2005 May;37(3):473-8. doi: 10.1016/j.aap.2004.07.007.

  PMID: 15784201 BACKGROUND

• Philip P, Sagaspe P, Taillard J, Valtat C, Moore N, Akerstedt T, Charles A, Bioulac B. Fatigue, sleepiness, and performance in simulated versus real driving conditions. Sleep. 2005 Dec;28(12):1511-6. doi: 10.1093/sleep/28.12.1511.

  PMID: 16408409 BACKGROUND

• Philip P, Taillard J, Moore N, Delord S, Valtat C, Sagaspe P, Bioulac B. The effects of coffee and napping on nighttime highway driving: a randomized trial. Ann Intern Med. 2006 Jun 6;144(11):785-91. doi: 10.7326/0003-4819-144-11-200606060-00004.

  PMID: 16754920 BACKGROUND

• Mitler MM, Gujavarty KS, Browman CP. Maintenance of wakefulness test: a polysomnographic technique for evaluation treatment efficacy in patients with excessive somnolence. Electroencephalogr Clin Neurophysiol. 1982 Jun;53(6):658-61. doi: 10.1016/0013-4694(82)90142-0.

  PMID: 6177511 BACKGROUND

• Sangal RB, Thomas L, Mitler MM. Maintenance of wakefulness test and multiple sleep latency test. Measurement of different abilities in patients with sleep disorders. Chest. 1992 Apr;101(4):898-902. doi: 10.1378/chest.101.4.898.

  PMID: 1555459 BACKGROUND

• Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. doi: 10.1016/0165-1781(91)90027-m.

  PMID: 2062970 BACKGROUND

• Vallieres A, Morin CM. Actigraphy in the assessment of insomnia. Sleep. 2003 Nov 1;26(7):902-6. doi: 10.1093/sleep/26.7.902.

  PMID: 14655927 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• 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.

  PMID: 24587570 RESULT

MeSH Terms

Conditions

Narcolepsy; Disorders of Excessive Somnolence

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Pierre PHILIP, MD, PHD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 9, 2009
• Study Start: March 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 14, 2026

Record last verified: 2013-04

Locations

FR (2)