Clinical trial NCT02710487: Sleep, Awake & Move - Part II
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's disease, Sleep Benefit
Lead sponsor: Neurocenter of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: Parkinson Schweiz
name: Ente Ospedaliero Cantonale, Bellinzona
name: Penn State University
First posted: 2016-03-16
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Awakening from NREM vs. REM sleep.
Primary purpose: OTHER

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. 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Overnight change in objective motor performance
timeFrame: 12 hours
Secondary outcomes:
measure: Overnight change in subjective motor performance
timeFrame: 12 hours
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland
Study officials:
affiliation: Neurocenter of Southern Switzerland
name: Pietro Luca Ratti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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