AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)
- Conditions
- Parkinson Disease
- Interventions
- Device: connected smartwatch
- Registration Number
- NCT06444789
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Development cohort of matched controls = people who don't have RBD age and sex matched connected smartwatch Detection of RBD signs by using the connected smartwach during 4 weeks Development cohort of patients with known RBD connected smartwatch Detection of RBD signs by using the connected smartwach during 4 weeks Confirmation cohort of parkinson disease patients = people who are supposed to have RBD connected smartwatch Detection of RBD signs by using the connected smartwach during 3 months
- Primary Outcome Measures
Name Time Method 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 4 weeks the digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort
- Secondary Outcome Measures
Name Time Method Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments. 4 weeks (for development cohort) and 3 months (for confirmation cohort) correlation between a) and b) 4 weeks for a) 3 months for 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 cohortNumber of cognitive tasks completed by each participant relative to the number of scheduled cognitive tasks. 4 weeks (for development cohort) and 3 months (for confirmation cohort)
Trial Locations
- Locations (4)
Hospital Ruber Internacional
🇪🇸Madrid, Spain
King's college of London (Regulatory authorization pending)
🇬🇧London, United Kingdom
Neurology Toulouse Hospital
🇫🇷Toulouse, France
Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pending)
🇩🇪Dresden, Germany