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

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

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.

Inclusion Criteria for development cohort:

Group of RBD patients

• Diagnosis of RBD (confirmed by polysomnography)
• Able to use a compatible smartphone with the study app
• Having a care partner with whom they share their bedroom at night

Group of Healthy matched controls:

• Healthy volunteers age and sex matched to the enrolled RBD patients.
• Able to use a compatible smartphone with the study app
• No history of RBD.

Inclusion Criteria for confirmation cohort

• Clinical confirmed diagnosis of PD
• RBD Screening Questionnaire score : 3 - 12 points
• Absence of dementia
• Able to use a compatible smartphone with the study app
• Having a care partner with whom they share their bedroom at night

Exclusion Criteria for all cohorts:

Inability to consent for study procedures as judged by the investigator. Lacking motivation to participate in study procedures as judged by the investigator.

Lack of social security.