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Completed

NCT Number: NCT02723396

Sleep, Awake & Move - Part I

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lugano, 6903, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Objective prospective and repeated assessment of motor function

    Time frame: from day 0 to day 15

    Finger tapping test

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Neurocenter of Southern Switzerland

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SA&M-I

Important dates

Study start
2016
Primary completion
2019
Study completion
2024
First posted
Mar 30, 2016
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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