Modafinil for the treatment of daytime sleepiness in Parkinson's disease: A double-blind, randomized, crossover, placebo-controlled polygraphic trial

Sleep

Volumn 25, Issue 8, 2002, Pages 905-909

  Hogl B ^a   Saletu, M ^a   Brandauer, E ^a   Glatzl, S ^a   Frauscher, B ^a   Seppi, K ^a   Ulmer, H ^a   Wenning, G ^a   Poewe, Werner ^a,b  

^a UNIVERSITY OF INNSBRUCK   (Austria)

^b Universitatsklinik fur Neurochirurgie Innsbruck   (Austria)

Author keywords

Epworth sleepiness scale; Maintenance of wakefulness test; Modafinil; Parkinson's disease; Polysomnography; Sleep; Sleepiness

Indexed keywords

MODAFINIL; PLACEBO;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; FEMALE; FLATULENCE; HUMAN; INSOMNIA; LATENT PERIOD; MAJOR CLINICAL STUDY; MALE; PARKINSON DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SLEEP TIME; SOMNOLENCE; VERTIGO; WAKEFULNESS;

EID: 0037114678     PISSN: 01618105     EISSN: None     Source Type: Journal    
DOI: 10.1093/sleep/25.8.62     Document Type: Article

References (44)

1. Rye DB, Bliwise DL. Movement disorders specific to sleep and the nocturnal manifestations of waking movement disorders. In: Watts RL, Koller WC, eds. Movement Disorders, Neurological Principles and Practice. Mc Graw-Hill; 1997:687-713
2. Rye DB, Bliwise DL, Dihenia B, Gurecki P. Daytime sleepiness in Parkinson's disease. J Sleep Res 2000;9:63-9
3. Factor SA, McAlarney T, Sanchez-Ramos JR, Weiner WJ. Sleep disorders and sleep effect in Parkinson's disease. Mov Disord 1990;5:280-5
4. Poewe W, Hogl B. Parkinson's disease and sleep. Curr Opin Neurol 2000:13:423-6
5. Ondo WG, Dat Vuong K, Khan H, Atassi F, Kwak C, Jankovic J. Daytime sleepiness and other sleep disorders in Parkinson's disease. Neurology 2001;57:1392-6
6. Frucht S, Rogers JD, Greene PE, Gordon MF, Fahn S. Falling asleep at the wheel: Motor vehicle mishaps in persons taking pramipexole and ropinirole. Neurology 1999;52:1908-10
7. Rye DB, Johnston LH, Watts RL, Bliwise DL. Juvenile Parkinson's disease with REM sleep behavior disorder, sleepiness, and daytime REM onset. Neurology 1999;53:1868-70
8. Arnulf I, Bonnet AM, Damier P, Bejjani BP, Seilhean D, Derenne JP, Agid Y. Hallucinations, REM sleep, and Parkinson's disease: A medical hypothesis. Neurology 2000;55:281-8
9. Hauser RA, Wahba MN, Zesiewicz TA, McDowell Anderson W. Modafinil treatment of pramipexole-associated somnolence. Mov Disord 2000;15:1269-71
10. Happe S, Pirker W, Sauter C, Klösch G, Zeitlhofer J. Successful treatment of excessive daytime sleepiness in Parkinson's disease with modafinil. J Neurol 2001;248:632-4
11. Rabinstein A, Shulman LM, Weiner WJ. Modafinil for the treatment of excessive daytime sleepiness in Parkinson's disease: A case report. Parkinsonism Relat Disord 2001;7:287-8
12. Johns MW. A new method for measuring daytime sleepiness: The epworth sleepiness scale. Sleep 1991;14:540-5
13. ASDA Standard of Practice Committee: Practice parameters for the indications for polysomnography and related procedures. Polysomnography task force. Sleep 1997;20:406-22
14. Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: A clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry 1992;55:181-4
15. Beck AT. Inventory for measuring depression. Arch Gen Psychiat 1961;4:561-71
16. Fahn S, Elton RL, and members of the UPDRS Development Committee. Unified Parkinson's Disease Rating Scale. In: Fahn S, Marsden CD, Calne DB, Goldstein M, eds. Recent developments in Parkinson's disease. Florham Park, NJ: MacMillan Healthcare Information. 1987;2:153-163;293-304
17. Johns MW. Reliability and factor analysis of the Epworth Sleepiness Scale. Sleep 1992;15:376-81
18. Doghramji K. Maintenance of wakefulness test. In: Chokroverty S, ed. Sleep Disorders Medicine, 2th Ed. Woburn: Butterworth-Heinemann 1999:231-6
19. Jasper HH: The Ten Twenty Electrode System of the International Federation. Electroenceph Clin Neurophysiol 1958:10:371-5
20. Rechtschaffen A, Kales A. A Manual of Standardized Techniques and Scoring System for Sleep Stages of Human Sleep. Los Angeles: UCLA Brain Information Service/Brain Research Institute, 1968.
21. Chervin RD, Aldrich MS. The Epworth Sleepiness Scale may not reflect objective measures of sleepiness or sleep apnea. Neurology 1999;52:125-31
22. Pack A, Black JE, Schwartz JR, Matheson JK. Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea. Am J Respir Crit Care Med. 2001;164:1675-81
23. Hobson DE, Lang AE, Martin WR, Razmy A, Rivest J, Fleming J. Excessive daytime sleepiness and sudden-onset sleep in Parkinson disease: A survey by the Canadian Movement Disorders Group. JAMA. 2002;287:455-63
24. Sangal RB, Mitler MM, Sangal JM. Subjective sleepiness ratings (Epworth sleepiness scale) do not reflect the same parameter of sleepiness as objective sleepiness (maintenance of wakefulness test) in patients with narcolepsy. Clin Neurophysiol 1999;110:2131-5
25. Olson LG, Cole MF, Ambrogetti A. Corrrelations among Epworth Sleepiness Scale scores, multiple sleep latency tests and psychological symptoms. J Sleep Res 1998;7:248-53
26. Johns MW. Sensitivity and specificity of the multiple sleep latency test (MSLT), the maintenance of wakefulness test and the epworth sleepiness scale: Failure of the MSLT as a gold standard. J Sleep Res 2000;9:5-11
27. Chervin RD. The multiple sleep latency test and Epworth sleepiness scale in the assessment of daytime sleepiness. J Sleep Res 2000;9:399-401
28. Johns MW. Reply. J of Sleep Res 2000;9:400-1
29. Mitler MM, Doghramji K, Shapiro C. The maintenance of wakefulness test normative data by age. J of Psychosom Res 2000;49:363-5
30. Veasey SC, Valladares O, Fenik P, Kapfhamer D, Sanford L, Benington J, Bucan M. An automated system for recording and analysis of sleep in mice. Sleep 2000;23:1025-40
31. Tobler I, Deboer T, Fischer M. Sleep and sleep regulation in normal and prion protein-deficient mice. J Neurosci 1997;17:1869-79
32. Toth LA. Identifying genetic influences on sleep: An approach to discovering the mechanisms of sleep regulation. Behav Genet 2001;31:39-46
33. Montastruc JL, Rascol O. Modafinil and pramipexole-associated somnolence. Mov Disord 2001;16:783-4
34. Adler CH, Caviness JN, Hentz JG, Lind M, Tiede J. Effect of modafinil on excessive daytime sleepiness associated with Parkinson disease. Sleep 2001; 24 Abstract Supplement:A368
35. Jouvet M, Albarede JL, Lubin S, Meyrignac C. Noradrenaline and cerebral aging. Encephale 1991, 17:187-95
36. Saletu B, Saletu M, Gränberger J, Frey R, Zatschek I, Mader R. On the treatment of the alcoholic organic brain syndrome with an alphaadrenergic agonist modafinil: Double-blind, placebo-controlled, clinical, psychometric and neurophysiological study. Prog Neuropsychopharmacol Biol Psychiat 1990;14:195-214
37. Ferraro L, Antonelli T, O'Connor WT, Tanganelli S, Rambert FA, Fuxe K. The effects of modafinil on striatal, pallidal and nigral GABA and glutamate release in the conscious rat: Evidence for a preferential inhibition of striato-pallidal GABA transmission. Neurosci Lett 1998;253:135-8
38. Chemelli RM, Willie JT, Sinton CM et al. Narcolepsy in orexin knockout mice: Molecular genetics of sleep regulation. Cell 1999;98:437-51
39. Lin JS, Hou Y, Jouvet M. Potential brain neuronal targets for amphetamine-, methylphenidate-, and modafinil-induced wakefulness, evidenced by c-fos immunocytochemistry in the cat. Proc Natl Acad Sci USA 1996;93:14128-33
40. Wisor JP, Nishino S, Sora I, Uhl GH, Mignot E, Edgar DM. Dopaminergic role in stimulant-induced wakefulness. J of Neurosci 2001;21:1787-94
41. Mahowald MW. Eyes wide shut. The dangers of sleepy driving. Minn Med 2000;83:25-30
42. Connor J, Whitlock G, Norton R, Jackson R. The role of driver sleepiness in car crashes: a systematic review of epidemiological studies. Accid Anal Prev 2001;33:31-41
43. Broughton R, Ghanem Q, Hishikawa Y, et al: Life effects of narcolepsy in 180 patients from North America, Asia and Europe compared to matched controls. Can J Neurol Sci 1981;8:299-304
44. Nieves AV, Lang AE. Treatment of excessive daytime sleepiness in patients with Parkinson's disease with modafinil. Clin Neuropharmacol 2002;25:111-4