Sleep, Awake & Move - Part I (SA&M-I)
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|ClinicalTrials.gov Identifier: NCT02723396|
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : August 27, 2018
|Condition or disease|
|Idiopathic Parkinson Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study|
|Actual Study Start Date :||March 16, 2016|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Prospective observation of a cohort of consecutive patients with idiopathic PD in an ecological setting.
The same assessments will be performed in a subgroup of age- and sex-matched healthy volunteers.
- Objective prospective and repeated assessment of motor function [ Time Frame: from day 0 to day 15 ]Finger tapping test
- Objective prospective and repeated assessment of motor function [ Time Frame: from day 0 to day 15 ]Tri-axial accelerometry (from wrist actigraphy)
- Subjective prospective and repeated assessment of motor function [ Time Frame: from day 0 to day 15 ]Visual analogue scale (VAS)
- Objective prospective assessment of sleep and wakefulness [ Time Frame: from day 0 to day 15 ]Wrist actigraphy
- Subjective prospective assessment of sleep and wakefulness [ Time Frame: from day 0 to day 15 ]Electronic sleep diary
- Subjective prospective assessment of sleepiness [ Time Frame: from day 0 to day 15 ]Stanford Sleepiness Scale (SSS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723396
|Contact: Pietro Luca Ratti, MD, PhD||+41(0)918116849||PietroLuca.Ratti@eoc.ch|
|Contact: Francesco Mezzanotte, PhD||+41(0)918116374||Francesco.Mezzanotte@eoc.ch|
|Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland||Recruiting|
|Lugano, Switzerland, 6903|
|Contact: Pietro Luca Ratti, MD, PhD +41(0)918116849 PietroLuca.Ratti@eoc.ch|
|Contact: Francesco Mezzanotte, PhD +41(0)918116374 Francesco.Mezzanotte@eoc.ch|
|Principal Investigator: Pietro Luca Ratti, MD, PhD|
|Sub-Investigator: Alain Kälin-Lang, Pr, MD, PhD|
|Sub-Investigator: Francesco Mezzanotte, Med. Stud.|
|Sub-Investigator: Paulo Edson Nunes Ferreira|
|Sub-Investigator: Sandra Hackethal, MD|
|Principal Investigator:||Pietro Luca Ratti, MD, PhD||Neurocenter of Southern Switzerland|