Clinical trial NCT02723396: Sleep, Awake & Move - Part I
Official title: Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson 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: 2016-03-30
Enrollment: 67
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with mild to moderate idiopathic Parkinson's Disease

Control group (n=30): age-and sex-matched healthy volunteers, matched with the first 30 subjects with Parkinson's Disease enrolled in the study and with a complete dataset available.

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.

Eligibility 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.

Primary outcomes:
measure: Objective prospective and repeated assessment of motor function
timeFrame: from day 0 to day 15
Secondary outcomes:
measure: Objective prospective and repeated assessment of motor function
timeFrame: from day 0 to day 15
measure: Subjective prospective and repeated assessment of motor function
timeFrame: from day 0 to day 15
measure: Objective prospective assessment of sleep and wakefulness
timeFrame: from day 0 to day 15
measure: Subjective prospective assessment of sleep and wakefulness
timeFrame: from day 0 to day 15
measure: Subjective prospective assessment of sleepiness
timeFrame: from day 0 to day 15
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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