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SA&M-I: Sleep, Awake & Move - Part I

Sponsor
Neurocenter of Southern Switzerland (Other)
Overall Status
Unknown status
CT.gov ID
NCT02723396
Collaborator
Parkinson Schweiz (Other), Ente Ospedaliero Cantonale, Bellinzona (Other), Penn State University (Other)
80
Enrollment
1
Location
39.5
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

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. 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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated 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 :
    Mar 16, 2016
    Anticipated Primary Completion Date :
    May 31, 2019
    Anticipated Study Completion Date :
    Jun 30, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. Objective prospective and repeated assessment of motor function [from day 0 to day 15]

      Finger tapping test

    Secondary Outcome Measures

    1. Objective prospective and repeated assessment of motor function [from day 0 to day 15]

      Tri-axial accelerometry (from wrist actigraphy)

    2. Subjective prospective and repeated assessment of motor function [from day 0 to day 15]

      Visual analogue scale (VAS)

    3. Objective prospective assessment of sleep and wakefulness [from day 0 to day 15]

      Wrist actigraphy

    4. Subjective prospective assessment of sleep and wakefulness [from day 0 to day 15]

      Electronic sleep diary

    5. Subjective prospective assessment of sleepiness [from day 0 to day 15]

      Stanford Sleepiness Scale (SSS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland Lugano Switzerland 6903

    Sponsors and Collaborators

    • Neurocenter of Southern Switzerland
    • Parkinson Schweiz
    • Ente Ospedaliero Cantonale, Bellinzona
    • Penn State University

    Investigators

    • Principal Investigator: Pietro Luca Ratti, MD, PhD, Neurocenter of Southern Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Mar 30, 2016
    Last Update Posted:
    Aug 27, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pietro Luca Ratti, MD, PhD, Neurocenter of Southern Switzerland
    Parkinson's disease
    Sleep Benefit
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Aug 27, 2018