Sleep, Awake & Move - Part II

Neurocenter of Southern Switzerland24 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Idiopathic Parkinson's Disease

Interventions

REMSABEHAVIORAL

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

NREMSABEHAVIORAL

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

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Lugano, Switzerland

Outcomes

Primary Outcomes

Overnight change in objective motor performance

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).

Time frame: 12 hours

Secondary Outcomes

Overnight change in subjective motor performance

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)

Time frame: 12 hours

Data from ClinicalTrials.gov

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