Sleep, Awake & Move - Part I

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. 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
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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.

Official Title
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Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study

Conditions
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Idiopathic Parkinson Disease

Participation Criteria
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Eligibility Criteria
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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.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson<br>Prospective observation of a cohort of consecutive patients with idiopathic PD in an ecological setting. | |
| Healthy<br>The same assessments will be performed in a subgroup of age- and sex-matched healthy volunteers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective prospective and repeated assessment of motor function | Finger tapping test | from day 0 to day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective prospective and repeated assessment of motor function | Tri-axial accelerometry (from wrist actigraphy) | from day 0 to day 15 | 
| Subjective prospective and repeated assessment of motor function | Visual analogue scale (VAS) | from day 0 to day 15 | 
| Objective prospective assessment of sleep and wakefulness | Wrist actigraphy | from day 0 to day 15 | 
| Subjective prospective assessment of sleep and wakefulness | Electronic sleep diary | from day 0 to day 15 | 
| Subjective prospective assessment of sleepiness | Stanford Sleepiness Scale (SSS) | from day 0 to day 15 | 

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