Sleep, Awake & Move - Part I

Idiopathic Parkinson Disease Clinical Trial

— SA&M-I  

Official title:

Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723396
• Other study ID #: EOC.NSI.LS.15.3.I
• Status: Completed
• Start date: March 16, 2016
• Est. completion date: February 9, 2024

Study information

• Verified date: February 2024
• Source: Neurocenter of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The "Sleep & Move" study is the first part of the Sleep, Awake & Move project. In this observational study we plan to systematically investigate SB and the day-to-day variation in this phenomenon in PD patients by a prospective, repeated assessment for 14 days of both subjective and objective measures of motor function and sleep at patients' home, by an Android app developed ad hoc by our group and named "SleepFit". 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Idiopathic Parkinson Disease
• Parkinson Disease

Locations

Country	Name	City	State
Switzerland	Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland	Lugano

Sponsors (4)

Lead Sponsor	Collaborator
Neurocenter of Southern Switzerland	Ente Ospedaliero Cantonale, Bellinzona, Parkinson Schweiz, Penn State University

Country where clinical trial is conducted

Switzerland, 

References & Publications (14)

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

Outcome

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