Idiopathic Parkinson 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. This study aims at systematically characterizing SB in PD patients in an ecological setting and to explore the relationships between nocturnal and diurnal sleep and subjective and objective measures of motor function. A better understanding of this phenomenon is mandatory for future research on this topic.
Detailed description
The Sleep & Move study is the first part of the Sleep, Awake & Move project. In this observational study we plan to systematically investigate SB and the day-to-day variation in this phenomenon in PD patients by a prospective, repeated assessment for 14 days of both subjective and objective measures of motor function and sleep at patients' home, by an Android app developed ad hoc by our group and named SleepFit. Since is still unknown if a spontaneous, subclinical improvement in motor performance might also occur in healthy subjects or if the SB is a phenomenon only involving subjects with PD, we had the idea to test this hypothesis comparing a subgroup of PD patients with age- and sex-matched healthy volunteers, employing the same assessments as in the Sleep & Move study.
Interventions
None listed
Sponsors
Parkinson Schweiz
Ente Ospedaliero Cantonale, Bellinzona
Penn State University
Neurocenter of Southern Switzerland
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
PARKINSON'S DISEASE GROUP: 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 HEALTHY GROUP: Inclusion Criteria: * Absence of Parkinson's disease * Mentally and physically capable to give informed consent ALL SUBJECTS:
Exclusion criteria
* Atypical parkinsonian syndrome * Cognitive impairment (MMSE ≥ 26) * History of cerebro-vascular disease, epilepsy, or other disabling neurological diseases * Psychiatric disorders, excepting mild depression (BDI score \<14) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective prospective and repeated assessment of motor function | from day 0 to day 15 | Finger tapping test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective prospective and repeated assessment of motor function | from day 0 to day 15 | Tri-axial accelerometry (from wrist actigraphy) |
| Subjective prospective and repeated assessment of motor function | from day 0 to day 15 | Visual analogue scale (VAS) |
| Objective prospective assessment of sleep and wakefulness | from day 0 to day 15 | Wrist actigraphy |
| Subjective prospective assessment of sleep and wakefulness | from day 0 to day 15 | Electronic sleep diary |
| Subjective prospective assessment of sleepiness | from day 0 to day 15 | Stanford Sleepiness Scale (SSS) |
Countries
Switzerland
Outcome results
None listed