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

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ClinicalTrials.gov Identifier: NCT02723396
Recruitment Status : Unknown
Verified August 2018 by Pietro Luca Ratti, Neurocenter of Southern Switzerland.
Recruitment status was:  Recruiting
First Posted : March 30, 2016
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
Parkinson Schweiz
Ente Ospedaliero Cantonale, Bellinzona
Penn State University
Information provided by (Responsible Party):
Pietro Luca Ratti, Neurocenter of Southern Switzerland

Study Description
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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. 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.

Condition or disease
Idiopathic Parkinson Disease

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study
Actual Study Start Date : March 16, 2016
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Parkinson
Prospective observation of a cohort of consecutive patients with idiopathic PD in an ecological setting.
Healthy
The same assessments will be performed in a subgroup of age- and sex-matched healthy volunteers.


Outcome Measures
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Primary Outcome Measures :
  1. Objective prospective and repeated assessment of motor function [ Time Frame: from day 0 to day 15 ]
    Finger tapping test


Secondary Outcome Measures :
  1. Objective prospective and repeated assessment of motor function [ Time Frame: from day 0 to day 15 ]
    Tri-axial accelerometry (from wrist actigraphy)

  2. Subjective prospective and repeated assessment of motor function [ Time Frame: from day 0 to day 15 ]
    Visual analogue scale (VAS)

  3. Objective prospective assessment of sleep and wakefulness [ Time Frame: from day 0 to day 15 ]
    Wrist actigraphy

  4. Subjective prospective assessment of sleep and wakefulness [ Time Frame: from day 0 to day 15 ]
    Electronic sleep diary

  5. Subjective prospective assessment of sleepiness [ Time Frame: from day 0 to day 15 ]
    Stanford Sleepiness Scale (SSS)


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

PARKINSON'S DISEASE GROUP:

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

HEALTHY GROUP:

Inclusion Criteria:

  • Absence of Parkinson's disease
  • Mentally and physically capable to give informed consent

ALL SUBJECTS:

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723396


Contacts
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Contact: Pietro Luca Ratti, MD, PhD +41(0)918116849 PietroLuca.Ratti@eoc.ch
Contact: Francesco Mezzanotte, PhD +41(0)918116374 Francesco.Mezzanotte@eoc.ch

Locations
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Switzerland
Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland Recruiting
Lugano, Switzerland, 6903
Contact: Pietro Luca Ratti, MD, PhD    +41(0)918116849    PietroLuca.Ratti@eoc.ch   
Contact: Francesco Mezzanotte, PhD    +41(0)918116374    Francesco.Mezzanotte@eoc.ch   
Principal Investigator: Pietro Luca Ratti, MD, PhD         
Sub-Investigator: Alain Kälin-Lang, Pr, MD, PhD         
Sub-Investigator: Francesco Mezzanotte, Med. Stud.         
Sub-Investigator: Paulo Edson Nunes Ferreira         
Sub-Investigator: Sandra Hackethal, MD         
Sponsors and Collaborators
Neurocenter of Southern Switzerland
Parkinson Schweiz
Ente Ospedaliero Cantonale, Bellinzona
Penn State University
Investigators
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Principal Investigator: Pietro Luca Ratti, MD, PhD Neurocenter of Southern Switzerland
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pietro Luca Ratti, MD, PhD, Neurocenter of Southern Switzerland
ClinicalTrials.gov Identifier: NCT02723396    
Other Study ID Numbers: EOC.NSI.LS.15.3.I
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pietro Luca Ratti, Neurocenter of Southern Switzerland:
Parkinson's disease
Sleep Benefit
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases