Back to results

Sleep, Awake & Move - Part II (SA&M-II)

Primary Purpose

Idiopathic Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

REMSA

NREMSA

About this trial

This is an interventional other trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's disease, Sleep Benefit

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

REM Sleep Awakening (REMSA)

NREM Sleep Awakening (NREMSA)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT02710487

First Posted

March 12, 2016

Last Updated

August 23, 2018

Sponsor

Neurocenter of Southern Switzerland

Collaborators

Parkinson Schweiz, Ente Ospedaliero Cantonale, Bellinzona, Penn State University

1. Study Identification

Unique Protocol Identification Number

NCT02710487

Brief Title

Sleep, Awake & Move - Part II

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

March 3, 2016 (Actual)

Primary Completion Date

January 12, 2018 (Actual)

Study Completion Date

July 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Neurocenter of Southern Switzerland

Collaborators

Parkinson Schweiz, Ente Ospedaliero Cantonale, Bellinzona, Penn State University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Parkinson's Disease

Keywords

Parkinson's disease, Sleep Benefit

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Awakening from NREM vs. REM sleep.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

REM Sleep Awakening (REMSA)

Arm Type

Experimental

Arm Description

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.

Arm Title

NREM Sleep Awakening (NREMSA)

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

REMSA

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

NREMSA

Intervention Description

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

Primary Outcome Measure Information:

Title

Overnight change in objective motor performance

Description

Time Frame

12 hours

Secondary Outcome Measure Information:

Title

Overnight change in subjective motor performance

Description

Time Frame

12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pietro Luca Ratti, MD, PhD

Organizational Affiliation

Neurocenter of Southern Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Lugano

ZIP/Postal Code

6903

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17235126

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.

Results Reference

background

PubMed Identifier

16328297

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.

Results Reference

background

PubMed Identifier

18951542

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.

Results Reference

background

PubMed Identifier

23615667

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.

Results Reference

background

PubMed Identifier

9251067

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.

Results Reference

background

PubMed Identifier

9109914

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.

Results Reference

background

PubMed Identifier

10584665

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.

Results Reference

background

PubMed Identifier

10449564

Citation

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.

Results Reference

background

PubMed Identifier

24084381

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.

Results Reference

background

PubMed Identifier

9595983

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.

Results Reference

background

PubMed Identifier

11481684

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.

Results Reference

background

PubMed Identifier

10877630

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.

Results Reference

background

PubMed Identifier

9596032

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.

Results Reference

background

PubMed Identifier

24781810

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.

Results Reference

background

Learn more about this trial

Sleep, Awake & Move - Part II

We'll reach out to this number within 24 hrs