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

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.