Idiopathic Parkinson Disease Clinical Trial
— SA&M-IOfficial title:
Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study
Verified date | February 2024 |
Source | Neurocenter of Southern Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory improvement in motor function reported by around 50% of patients affected by Parkinson's Disease (PD) after sleep and before taking their first dose of dopaminergic medications. This study aims at systematically characterizing SB in PD patients in an ecological setting and to explore the relationships between nocturnal and diurnal sleep and subjective and objective measures of motor function. A better understanding of this phenomenon is mandatory for future research on this topic.
Status | Completed |
Enrollment | 67 |
Est. completion date | February 9, 2024 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years and older |
Eligibility | PARKINSON'S DISEASE GROUP: Inclusion Criteria: - Diagnostic criteria of idiopathic Parkinson's disease (UKPDBB) - Mild to moderate disease (Hoehn & Yahr score = 1 and <= 3) - Mentally and physically capable to give informed consent - Stable antiparkinsonian and psychotropic therapy for the last 30 days HEALTHY GROUP: Inclusion Criteria: - Absence of Parkinson's disease - Mentally and physically capable to give informed consent ALL SUBJECTS: Exclusion Criteria: - Atypical parkinsonian syndrome - Cognitive impairment (MMSE = 26) - History of cerebro-vascular disease, epilepsy, or other disabling neurological diseases - Psychiatric disorders, excepting mild depression (BDI score <14) - Alcohol abuse - Other clinically significant severe concomitant disease states - Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, etc.) - Participation in another study with investigational drug within the 60 days preceding and during the present project. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland | Lugano |
Lead Sponsor | Collaborator |
---|---|
Neurocenter of Southern Switzerland | Ente Ospedaliero Cantonale, Bellinzona, Parkinson Schweiz, Penn State University |
Switzerland,
Bateman DE, Levett K, Marsden CD. Sleep benefit in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1999 Sep;67(3):384-5. doi: 10.1136/jnnp.67.3.384. No abstract available. — View Citation
Currie LJ, Bennett JP Jr, Harrison MB, Trugman JM, Wooten GF. Clinical correlates of sleep benefit in Parkinson's disease. Neurology. 1997 Apr;48(4):1115-7. doi: 10.1212/wnl.48.4.1115. — View Citation
De Cock VC, Vidailhet M, Leu S, Texeira A, Apartis E, Elbaz A, Roze E, Willer JC, Derenne JP, Agid Y, Arnulf I. Restoration of normal motor control in Parkinson's disease during REM sleep. Brain. 2007 Feb;130(Pt 2):450-6. doi: 10.1093/brain/awl363. — View Citation
Factor SA, Weiner WJ. 'Sleep benefit' in Parkinson's disease. Neurology. 1998 May;50(5):1514-5. doi: 10.1212/wnl.50.5.1514-b. No abstract available. — View Citation
Hogl B, Gershanik O. Sleep benefit in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2000 Jun;68(6):798-9. doi: 10.1136/jnnp.68.6.798a. No abstract available. — View Citation
Hogl B, Peralta C, Wetter TC, Gershanik O, Trenkwalder C. Effect of sleep deprivation on motor performance in patients with Parkinson's disease. Mov Disord. 2001 Jul;16(4):616-21. doi: 10.1002/mds.1138. — View Citation
Hogl BE, Gomez-Arevalo G, Garcia S, Scipioni O, Rubio M, Blanco M, Gershanik OS. A clinical, pharmacologic, and polysomnographic study of sleep benefit in Parkinson's disease. Neurology. 1998 May;50(5):1332-9. doi: 10.1212/wnl.50.5.1332. — View Citation
Merello M, Hughes A, Colosimo C, Hoffman M, Starkstein S, Leiguarda R. Sleep benefit in Parkinson's disease. Mov Disord. 1997 Jul;12(4):506-8. doi: 10.1002/mds.870120405. — View Citation
Noyce AJ, Nagy A, Acharya S, Hadavi S, Bestwick JP, Fearnley J, Lees AJ, Giovannoni G. Bradykinesia-akinesia incoordination test: validating an online keyboard test of upper limb function. PLoS One. 2014 Apr 29;9(4):e96260. doi: 10.1371/journal.pone.0096260. eCollection 2014. Erratum In: PLoS One. 2014;9(8):e105488. — View Citation
Sherif E, Valko PO, Overeem S, Baumann CR. Sleep benefit in Parkinson's disease is associated with short sleep times. Parkinsonism Relat Disord. 2014 Jan;20(1):116-8. doi: 10.1016/j.parkreldis.2013.09.005. Epub 2013 Sep 12. — View Citation
Stefani A, Galati S, Peppe A, Bassi A, Pierantozzi M, Hainsworth AH, Bernardi G, Orlacchio A, Stanzione P, Mazzone P. Spontaneous sleep modulates the firing pattern of parkinsonian subthalamic nucleus. Exp Brain Res. 2006 Jan;168(1-2):277-80. doi: 10.1007/s00221-005-0175-y. Epub 2005 Nov 18. — View Citation
Tandberg E, Larsen JP, Karlsen K. Excessive daytime sleepiness and sleep benefit in Parkinson's disease: a community-based study. Mov Disord. 1999 Nov;14(6):922-7. doi: 10.1002/1531-8257(199911)14:63.0.co;2-7. — View Citation
Urrestarazu E, Iriarte J, Alegre M, Clavero P, Rodriguez-Oroz MC, Guridi J, Obeso JA, Artieda J. Beta activity in the subthalamic nucleus during sleep in patients with Parkinson's disease. Mov Disord. 2009 Jan 30;24(2):254-60. doi: 10.1002/mds.22351. — View Citation
van Gilst MM, Bloem BR, Overeem S. "Sleep benefit" in Parkinson's disease: a systematic review. Parkinsonism Relat Disord. 2013 Jul;19(7):654-9. doi: 10.1016/j.parkreldis.2013.03.014. Epub 2013 Apr 21. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective prospective and repeated assessment of motor function | Finger tapping test | from day 0 to day 15 | |
Secondary | Objective prospective and repeated assessment of motor function | Tri-axial accelerometry (from wrist actigraphy) | from day 0 to day 15 | |
Secondary | Subjective prospective and repeated assessment of motor function | Visual analogue scale (VAS) | from day 0 to day 15 | |
Secondary | Objective prospective assessment of sleep and wakefulness | Wrist actigraphy | from day 0 to day 15 | |
Secondary | Subjective prospective assessment of sleep and wakefulness | Electronic sleep diary | from day 0 to day 15 | |
Secondary | Subjective prospective assessment of sleepiness | Stanford Sleepiness Scale (SSS) | from day 0 to day 15 |
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