Sleep, Awake & Move - Part II

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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.

Conditions
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Idiopathic Parkinson's Disease

Intervention / Treatment
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* Behavioral: REMSA
* Behavioral: NREMSA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Awakening from NREM vs. REM sleep.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REM Sleep Awakening (REMSA)<br>The investigators will actively awaken each subject from nocturnal REM sleep in a sleep laboratory setting, in the hour preceding her/his habitual wake time. | Behavioral: REMSA<br>* Awakening from REM sleep during the last hour of the sleep period<br>|
| Experimental: NREM Sleep Awakening (NREMSA)<br>Awakening from the NREM sleep stage N2 will be the control intervention. | Behavioral: NREMSA<br>* Awakening from N2 (NREM) sleep during the last hour of the sleep period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Sleep Benefit