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Completed

NCT Number: NCT02710487

Sleep, Awake & Move - Part II

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lugano, 6903, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

REMSA

Behavioral

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

NREMSA

Behavioral

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

Primary outcomes

  1. Overnight change in objective motor performance

    Time frame: 12 hours

    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).

Secondary outcomes

  1. Overnight change in subjective motor performance

    Time frame: 12 hours

    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)

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

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.

Acronym: SA&M-II

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2016
Registry last updated
Aug 27, 2018

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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