dBM-dev study is a multicentre low-intervention research study which concerns REM sleep behaviour disorder (RBD) who is the best predictor for neurodegenerative diseases including Parkinson's disease (PD). RBD can only be confirmed by polysomnography, which is a cumbersome procedure. The main objective of this study is to identify a novel, robust dBM for the detection of RBD using smartwatch-based recordings of passive data.The study is conducted step-wise on two subsequent cohorts referred to as the development cohort and the confirmation cohort.
The development cohort comprises 30 patients with RBD and 30 matched controls on sex and age with patients RBD. The confirmation cohort comprises 30 patients with PD. Following a baseline visit comprising standard clinical evaluation and Parkinson questionnaires, participants will undergo daily-life dBM tracking over a duration of 4 weeks for development cohort and 3 months for confirmation cohort. Additionally, PD patients enrolled in the confirmation cohort will receive a polysomnography which permits to verificate if they have a RBD. The investigation is conducted in four European sites.
Study Type
OBSERVATIONAL
Enrollment
90
The smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD.
Neurology Toulouse Hospital
Toulouse, France
Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pending)
Dresden, Germany
Hospital Ruber Internacional
Madrid, Spain
King's college of London (Regulatory authorization pending)
London, United Kingdom
Incidence of nights in a confirmation cohort in which RBD episodes are indicated by a score (digital biomarker) derived from passive actigraphy and photoplethysmography data captured by a smartwatch
the digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort
Time frame: 4 weeks
correlation between a) and b)
1. the incidence of daytime somnolence episodes per week indicated by a score (digital biomarker) derived from passive actigraphy and photoplethysmography data captured by a smartwatch. The digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort 2. the score of the Epworth Sleepiness Scale at baseline, measured by the Spearman correlation coefficient, in a confirmation cohort
Time frame: 4 weeks for a) 3 months for b)
Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments.
Time frame: 4 weeks (for development cohort) and 3 months (for confirmation cohort)
Number of cognitive tasks completed by each participant relative to the number of scheduled cognitive tasks.
Time frame: 4 weeks (for development cohort) and 3 months (for confirmation cohort)
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