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NOT YET RECRUITING
NCT06444789

AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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.

Official title: AI-based Parkinson's Disease Risk Assessment and Prognosis - Digital Biomarkers Development, Validation and Verification Study (AI-PROGNOSIS dBM-DEV Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

90

Start Date

2024-09-20

Completion Date

2025-07-15

Last Updated

2024-08-27

Healthy Volunteers

Yes

Interventions

DEVICE

connected smartwatch

The smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD.

Locations (4)

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