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Idiopathic Parkinson DiseaseSA&M-INCT02723396

Sleep, Awake & Move - Part I

An observational study of Idiopathic Parkinson 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 olderHealthy volunteers can take part
Conditions the study is for
Idiopathic Parkinson Disease
How many people
67 participants
Where
1 siteSwitzerland
Study dates
16 Mar 2016to 9 Feb 2024
Phase
Observational
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Outpatients with mild to moderate idiopathic Parkinson's Disease Control group (n=30): age-and sex-matched healthy volunteers, matched with the first 30 subjects with Parkinson's Disease enrolled in the study and with a complete dataset available.

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
  • HEALTHY GROUP:
  • Absence of Parkinson's disease
  • Mentally and physically capable to give informed consent
  • ALL SUBJECTS:

Who cannot join

  • 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.

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

Read the detailed 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.

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.

Study groups in NCT02723396
Study groupRoleWhat they receive
ParkinsonProspective observation of a cohort of consecutive patients with idiopathic PD in an ecological setting.
HealthyThe same assessments will be performed in a subgroup of age- and sex-matched healthy volunteers.

What is being measured

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

  1. Objective prospective and repeated assessment of motor function

    Finger tapping test

    Measured: from day 0 to day 15

Secondary outcomes (5)

  1. Objective prospective and repeated assessment of motor function

    Tri-axial accelerometry (from wrist actigraphy)

    Measured: from day 0 to day 15

  2. Subjective prospective and repeated assessment of motor function

    Visual analogue scale (VAS)

    Measured: from day 0 to day 15

  3. Objective prospective assessment of sleep and wakefulness

    Wrist actigraphy

    Measured: from day 0 to day 15

  4. Subjective prospective assessment of sleep and wakefulness

    Electronic sleep diary

    Measured: from day 0 to day 15

  5. Subjective prospective assessment of sleepiness

    Stanford Sleepiness Scale (SSS)

    Measured: from day 0 to day 15

Timeline

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

  1. First posted30 Mar 2016 (estimated)
  2. Study start16 Mar 2016
  3. Primary completion31 May 2019
  4. Study completion9 Feb 2024

Resources

More details

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

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02723396
Sponsor's protocol ID
EOC.NSI.LS.15.3.I
Acronym
SA&M-I
Status last verified
Feb 2024
First submitted
12 Mar 2016
Last updated
13 Feb 2024
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

  • Mascheroni A, Choe EK, Luo Y, Marazza M, Ferlito C, Caverzasio S, Mezzanotte F, Kaelin-Lang A, Faraci F, Puiatti A, Ratti PL. The SleepFit Tablet Application for Home-Based Clinical Data Collection in Parkinson Disease: User-Centric Development and Usability Study. JMIR Mhealth Uhealth. 2021 Jun 8;9(6):e16304. doi: 10.2196/16304.

    PubMed 34100767

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Parkinson 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 8 inclusion and 8 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 13 Feb 2024. 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?

Objective prospective and repeated assessment of motor function (time frame: from day 0 to day 15). 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 NCT02723396, which also lists 15 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 13 Feb 2024.

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