Sleep, Awake & Move - Part II

Idiopathic Parkinson's Disease Clinical Trial

— SA&M-II  

Official title:

Awake & Move. Role of Nocturnal Sleep and Rapid Eye Movement Sleep at Morning Awakening on Sleep Benefit in Parkinson's Disease. An Interventional Cross-over Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710487
• Other study ID #: EOC.NSI.LS.15.3.II
• Status: Completed
• Phase: N/A
• Start date: March 3, 2016
• Est. completion date: July 27, 2018

Study information

• Verified date: August 2018
• Source: Neurocenter of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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. The aim of this study is to test the hypothesis that objective and/or subjective improvement of motor function might be due to a carry-over effect of Rapid Eye Movements (REM) sleep at awakening from this sleep phase.

Description:

The "Awake & Move" study is the second part of the Sleep, Awake & Move project. This study will be conducted in a subgroup of unselected, consecutive patients having completed the part I of the Sleep, Awake & Move project (i.e. the "Sleep & Move" study). The investigators plan to explore the carry-over effect of REM sleep on motor function in a subgroup of PD subjects p. In this interventional study the investigators expect to induce SB by awakening the subjects from nocturnal REM sleep in a sleep laboratory setting, but not from Non-Rapid Eye Movements (NREM) sleep (control intervention).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 27, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Exclusion Criteria:

• Atypical parkinsonian syndrome

• Cognitive impairment (MMSE = 26)

• Deep brain stimulation

• History of cerebro-vascular disease, epilepsy, or other disabling neurological diseases

• Psychiatric disorders, excepting mild depression

• 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.

• subjects with (a) sleep-disordered breathing [Respiratory Disorder Index (RDI)= 5] and (b) with no clear-cut distinction of REM and NREM sleep, based on a video-polysomongraphical recording.

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Behavioral:
• REMSA
Awakening from REM sleep during the last hour of the sleep period
• NREMSA
Awakening from N2 (NREM) sleep during the last hour of the sleep period

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. — 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. — 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. — View Citation

Factor SA, Weiner WJ. 'Sleep benefit' in Parkinson's disease. Neurology. 1998 May;50(5):1514-5. — View Citation

Högl B, Gershanik O. Sleep benefit in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2000 Jun;68(6):798-9. — View Citation

Högl 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. — View Citation

Högl BE, Gómez-Arévalo G, García 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. — 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. — 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. 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. — View Citation

Urrestarazu E, Iriarte J, Alegre M, Clavero P, Rodríguez-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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overnight change in objective motor performance	The change of objective measures of morning motor performance at awakening from REM sleep compared to the morning motor performance at awakening from NREM sleep (stage N2), within the same subjects, by mean of an electronic finger tapping test and the Movement Disorders Society Unified Parkinson's Disease Rating Scale motor examination (MDS-UPDRS-III).	12 hours
Secondary	Overnight change in subjective motor performance	The change of subjective measures of morning motor performance at awakening from REM sleep compared to the morning motor performance at awakening from NREM sleep (stage N2), within the same subjects, by mean of the Scale for Outcome in Parkinson's Disease Diary Card (SCOPA-DC) and a visual analogue scale (VAS)	12 hours