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

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Device: connected smartwatch

Study type: Observational

Funder types: Other

Identifiers

NCT06444789

RC31/23/0184 - RC31/24/0031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

90 participants in 3 patient groups

Development cohort of patients with known RBD

Description:

Detection of RBD signs by using the connected smartwach during 4 weeks

Treatment:

Device: connected smartwatch

Development cohort of matched controls = people who don't have RBD age and sex matched

Description:

Detection of RBD signs by using the connected smartwach during 4 weeks

Treatment:

Device: connected smartwatch

Confirmation cohort of parkinson disease patients = people who are supposed to have RBD

Description:

Detection of RBD signs by using the connected smartwach during 3 months

Treatment:

Device: connected smartwatch