Sleep, Awake & Move - Part I

NCT02723396 | Completed

• 1 other identifier: EOC.NSI.LS.15.3.I
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Parkinson Disease

Keywords

Parkinson's disease; Sleep Benefit

Outcome Measures

Primary Outcomes (1)

• Objective prospective and repeated assessment of motor function

  Finger tapping test

  from day 0 to day 15

Secondary Outcomes (5)

• Objective prospective and repeated assessment of motor function

  from day 0 to day 15

• Subjective prospective and repeated assessment of motor function

  from day 0 to day 15

• Objective prospective assessment of sleep and wakefulness

  from day 0 to day 15

• Subjective prospective assessment of sleep and wakefulness

  from day 0 to day 15

• Subjective prospective assessment of sleepiness

  from day 0 to day 15

Study Arms (2)

Parkinson

Prospective observation of a cohort of consecutive patients with idiopathic PD in an ecological setting.

Healthy

The same assessments will be performed in a subgroup of age- and sex-matched healthy volunteers.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients with mild to moderate idiopathic Parkinson's Disease Control group (n=30): age-and sex-matched healthy volunteers, matched with the first 30 subjects with Parkinson's Disease enrolled in the study and with a complete dataset available.

You may qualify if:

• 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:
• Absence of Parkinson's disease
• Mentally and physically capable to give informed consent
• ALL SUBJECTS:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurocenter of Southern Switzerland: lead
• Parkinson Schweiz: collaborator
• Ente Ospedaliero Cantonale, Bellinzona: collaborator
• Penn State University: collaborator

Study Sites (1)

Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland

Lugano, 6903, Switzerland

Location

Related Publications (15)

• 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.

  PMID: 17235126 BACKGROUND

• 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.

  PMID: 16328297 BACKGROUND

• 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.

  PMID: 18951542 BACKGROUND

• 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.

  PMID: 23615667 BACKGROUND

• 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.

  PMID: 9251067 BACKGROUND

• 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.

  PMID: 9109914 BACKGROUND

• 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.

  PMID: 10584665 BACKGROUND

• 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.

  PMID: 10449564 BACKGROUND

• 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.

  PMID: 24084381 BACKGROUND

• 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.

  PMID: 9595983 BACKGROUND

• 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.

  PMID: 11481684 BACKGROUND

• 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.

  PMID: 10877630 BACKGROUND

• 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.

  PMID: 9596032 BACKGROUND

• 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.

  PMID: 24781810 BACKGROUND

• 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.

  PMID: 34100767 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Pietro Luca Ratti, MD, PhD

  Neurocenter of Southern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 12, 2016
• First Posted: March 30, 2016
• Study Start: March 16, 2016
• Primary Completion: May 31, 2019
• Study Completion: February 9, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)