Study Results
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Basic Information
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COMPLETED
67 participants
OBSERVATIONAL
2016-03-16
2024-02-09
Brief Summary
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Detailed Description
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Since is still unknown if a spontaneous, subclinical improvement in motor performance might also occur in healthy subjects or if the SB is a phenomenon only involving subjects with PD, we had the idea to test this hypothesis comparing a subgroup of PD patients with age- and sex-matched healthy volunteers, employing the same assessments as in the Sleep \& Move study.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Parkinson
Prospective observation of a cohort of consecutive patients with idiopathic PD in an ecological setting.
No interventions assigned to this group
Healthy
The same assessments will be performed in a subgroup of age- and sex-matched healthy volunteers.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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:
* Absence of Parkinson's disease
* Mentally and physically capable to give informed consent
ALL SUBJECTS:
Exclusion Criteria
* 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.
35 Years
ALL
Yes
Sponsors
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Parkinson Schweiz
OTHER
Ente Ospedaliero Cantonale, Bellinzona
OTHER
Penn State University
OTHER
Neurocenter of Southern Switzerland
OTHER
Responsible Party
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Pietro Luca Ratti
MD, PhD
Principal Investigators
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Pietro Luca Ratti, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Neurocenter of Southern Switzerland
Locations
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Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland
Lugano, , Switzerland
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Mascheroni A, Choe EK, Luo Y, Marazza M, Ferlito C, Caverzasio S, Mezzanotte F, Kaelin-Lang A, Faraci F, Puiatti A, Ratti PL. The SleepFit Tablet Application for Home-Based Clinical Data Collection in Parkinson Disease: User-Centric Development and Usability Study. JMIR Mhealth Uhealth. 2021 Jun 8;9(6):e16304. doi: 10.2196/16304.
Other Identifiers
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EOC.NSI.LS.15.3.I
Identifier Type: -
Identifier Source: org_study_id
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