Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland
Lugano, 6903, Switzerland
NCT Number: NCT02723396
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.
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Notify Me35 year and older
All sexes
Observational
Lugano, 6903, Switzerland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
PARKINSON'S DISEASE GROUP:
Inclusion criteria
HEALTHY GROUP:
Inclusion criteria
ALL SUBJECTS:
Exclusion criteria
Time frame: from day 0 to day 15
Finger tapping test
Time frame: from day 0 to day 15
Tri-axial accelerometry (from wrist actigraphy)
Time frame: from day 0 to day 15
Visual analogue scale (VAS)
Time frame: from day 0 to day 15
Wrist actigraphy
Time frame: from day 0 to day 15
Electronic sleep diary
Time frame: from day 0 to day 15
Stanford Sleepiness Scale (SSS)
Neurocenter of Southern Switzerland
Other
Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study
Acronym: SA&M-I
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