Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies - Full Text View

Purpose

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

Condition	Intervention
Narcolepsy Hypersomnia	Drug: Modafinil Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
Official Title:	Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment.

Resource links provided by NLM:

Genetics Home Reference related topics: narcolepsy

Drug Information available for: Modafinil Armodafinil

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

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 [ Time Frame: for each condition, at day 4 for patients or day 1 for healthy volonteers ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjective sleepiness (Karolinska and VAS scales) [ Time Frame: for each condition, at day 4 and 5 for patients or day 1 for healthy volonteers ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	March 2010
Study Completion Date:	August 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Modafinil First Treatment by Modafinil during first condition then placebo during second condition	Drug: Modafinil 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). Drug: Placebo 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.
Experimental: Placebo First Treatment by Placebo during first condition then Modafinil during second condition	Drug: Modafinil 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). Drug: Placebo 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.
No Intervention: H Healthy Volunteers

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916253

Locations

France
GENNPHASS - CHU de Bordeaux
Bordeaux, France, 33076
AP-HP - Hôpital de l'Hôtel-Dieu
Paris, France, 75181

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator:

Pierre PHILIP, MD, PHD

University Hospital, Bordeaux

More Information

Publications:

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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.

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

Findley LJ, Unverzagt ME, Suratt PM. Automobile accidents involving patients with obstructive sleep apnea. Am Rev Respir Dis. 1988 Aug;138(2):337-40.

[No authors listed] Sleep apnea, sleepiness, and driving risk. American Thoracic Society. Am J Respir Crit Care Med. 1994 Nov;150(5 Pt 1):1463-73. No abstract available.

Barbé, Pericás J, Muñoz A, Findley L, Antó JM, Agustí 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.

Terán-Santos J, Jiménez-Gómez 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.

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.

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.

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 1;30(3):327-30.

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.

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.

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.

Meurice JC, Marc I, Sériès 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.

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.

[No authors listed] 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.

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.

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.

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

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O'Hanlon JF, Volkerts ER. Hypnotics and actual driving performance. Acta Psychiatr Scand Suppl. 1986;332:95-104.

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.

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.

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 1;28(12):1511-6.

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. Summary for patients in: Ann Intern Med. 2006 Jun 6;144(11):I11.

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.

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.

Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8.

Vallières A, Morin CM. Actigraphy in the assessment of insomnia. Sleep. 2003 Nov 1;26(7):902-6.

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.

Responsible Party:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00916253 History of Changes
Other Study ID Numbers:	CHUBX 2008/37
Study First Received:	May 29, 2009
Last Updated:	April 24, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:

Sleep
real driving
simulated driving
MWT

Additional relevant MeSH terms:

Narcolepsy
Stress, Psychological
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Behavioral Symptoms

Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013

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