Sleep, Awake & Move - Part II
- Conditions
- Idiopathic Parkinson's Disease
- Interventions
- Behavioral: NREMSABehavioral: REMSA
- Registration Number
- NCT02710487
- Lead Sponsor
- Neurocenter of Southern Switzerland
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NREM Sleep Awakening (NREMSA) NREMSA Awakening from the NREM sleep stage N2 will be the control intervention. REM Sleep Awakening (REMSA) REMSA 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.
- Primary Outcome Measures
Name Time Method Overnight change in objective motor performance 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 Outcome Measures
Name Time Method Overnight change in subjective motor performance 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)
Trial Locations
- Locations (1)
Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland
🇨🇭Lugano, Switzerland