Idiopathic Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Sleep Benefit
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).
Interventions
BEHAVIORALREMSA
Awakening from REM sleep during the last hour of the sleep period
BEHAVIORALNREMSA
Awakening from N2 (NREM) sleep during the last hour of the sleep period
Sponsors
Parkinson Schweiz
Ente Ospedaliero Cantonale, Bellinzona
Penn State University
Neurocenter of Southern Switzerland
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The sleep technician in charge to apply the study intervention was the only person to be aware of the sleep phase the patient was awaken from.
Intervention model description
Awakening from NREM vs. REM sleep.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Switzerland
Outcome results
None listed