drugset / Trial / NCT00916253
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies
RandomizedCrossoverDouble-blindDiagnostic
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
Timeline
- Start
- 2010-03
- Primary completion
- 2012-07
- Completion
- 2012-08
Publications
- 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.
- 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.
- Background Philip P, Mitler M. Sleepiness at the wheel: symptom or behavior? Sleep. 2000 Jun 15;23 Suppl 4:S119-21. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Background Findley LJ, Suratt PM, Dinges DF; New Collective Author. 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.
- 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.
- Background Grubb TC. Narcolepsy and highway accidents. JAMA. 1969 Sep 15;209(11):1720. No abstract available.
- Background Bartels EC, Kusakcioglu O. Narcolepsy: a possible cause of automobile accidents. Lahey Clin Found Bull. 1965;14(1):21-6. No abstract available.
- Background Aldrich MS. Automobile accidents in patients with sleep disorders. Sleep. 1989 Dec;12(6):487-94. doi: 10.1093/sleep/12.6.487.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Modafinil | Small molecule | 400 mg | — |