NCT02723396

Sleep, Awake & Move - Part I

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 67 (actual)
• Sponsor: Neurocenter of Southern Switzerland · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Idiopathic Parkinson Disease

Timeline

• Start date: 2016-03-16
• Primary completion: 2019-05-31
• Completion: 2024-02-09
• First posted: 2016-03-30
• Last updated: 2024-02-13

Locations

1 site across 1 country: Switzerland