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Idiopathic Parkinson's DiseaseSA&M-IINCT02710487

Sleep, Awake & Move - Part II

A study testing REMSA and NREMSA in people with Idiopathic Parkinson's Disease, run by Neurocenter of Southern Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
REMSA and NREMSA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSwitzerland
Study dates
3 Mar 2016to 27 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

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

    Lugano, 6903

Other trials in Switzerland

About this study

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.

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.

Read the 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).

Being tested
REMSA, NREMSA
Keywords
Parkinson's disease, Sleep Benefit
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REMSABehavioural

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

  • NREMSABehavioural

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

Study groups in NCT02710487
Study groupRoleWhat they receive
REM Sleep Awakening (REMSA)ExperimentalThe investigators will actively awaken each subject from nocturnal REM sleep in a sleep laboratory setting, in the hour preceding her/his habitual wake time.
Receives: Behavioral: REMSA
NREM Sleep Awakening (NREMSA)ExperimentalAwakening from the NREM sleep stage N2 will be the control intervention.
Receives: Behavioral: NREMSA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 hours

Secondary outcomes (1)

  1. 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)

    Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2016 (estimated)
  2. Study start3 Mar 2016
  3. Primary completion12 Jan 2018
  4. Study completion27 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Crossover
Model description
Awakening from NREM vs. REM sleep.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02710487
Sponsor's protocol ID
EOC.NSI.LS.15.3.II
Acronym
SA&M-II
Status last verified
Aug 2018
First submitted
12 Mar 2016
Last updated
27 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17235126

  • 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.

    PubMed 16328297

  • 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.

    PubMed 18951542

  • 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.

    PubMed 23615667

  • 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.

    PubMed 9251067

  • 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.

    PubMed 9109914

  • 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.

    PubMed 10584665

  • 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.

    PubMed 10449564

  • 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.

    PubMed 24084381

  • 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.

    PubMed 9595983

  • 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.

    PubMed 11481684

  • 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.

    PubMed 10877630

  • 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.

    PubMed 9596032

  • 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.

    PubMed 24781810

Questions about this trial

What is this clinical trial studying?

A study testing REMSA and NREMSA in people with Idiopathic Parkinson's Disease, run by Neurocenter of Southern Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overnight change in objective motor performance (time frame: 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02710487, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.

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