Sleep, Awake & Move - Part II

NCT02710487 | Completed

• 1 other identifier: EOC.NSI.LS.15.3.II
• Study Type: interventional
• Target: 24
• 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. 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.

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's disease, Sleep Benefit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overnight change in subjective motor performance

  12 hours

Study Arms (2)

REM Sleep Awakening (REMSA)

EXPERIMENTAL

The investigators will actively awaken each subject from nocturnal REM sleep in a sleep laboratory setting, in the hour preceding her/his habitual wake time.

Behavioral: REMSA

NREM Sleep Awakening (NREMSA)

EXPERIMENTAL

Awakening from the NREM sleep stage N2 will be the control intervention.

Behavioral: NREMSA

Interventions

REMSA BEHAVIORAL

Awakening from REM sleep during the last hour of the sleep period

REM Sleep Awakening (REMSA)

NREMSA BEHAVIORAL

Awakening from N2 (NREM) sleep during the last hour of the sleep period

NREM Sleep Awakening (NREMSA)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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.

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 (14)

• 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

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: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The sleep technician in charge to apply the study intervention was the only person to be aware of the sleep phase the patient was awaken from.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Awakening from NREM vs. REM sleep.

Study Record Dates

• First Submitted: March 12, 2016
• First Posted: March 16, 2016
• Study Start: March 3, 2016
• Primary Completion: January 12, 2018
• Study Completion: July 27, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)