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

Not yet recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06444789
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-14
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Inclusion Criteria for development cohort:<br><br>Group of RBD patients<br><br> - Diagnosis of RBD (confirmed by polysomnography)<br><br> - Able to use a compatible smartphone with the study app<br><br> - Having a care partner with whom they share their bedroom at night<br><br>Group of Healthy matched controls:<br><br> - Healthy volunteers age and sex matched to the enrolled RBD patients.<br><br> - Able to use a compatible smartphone with the study app<br><br> - No history of RBD.<br><br>Inclusion Criteria for confirmation cohort<br><br> - Clinical confirmed diagnosis of PD<br><br> - RBD Screening Questionnaire score : 3 - 12 points<br><br> - Absence of dementia<br><br> - Able to use a compatible smartphone with the study app<br><br> - Having a care partner with whom they share their bedroom at night<br><br>Exclusion Criteria for all cohorts:<br><br>Inability to consent for study procedures as judged by the investigator. Lacking<br>motivation to participate in study procedures as judged by the investigator.<br><br>Lack of social security.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

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

Secondary Outcome Measures

Name	Time	Method
correlation between a) and b);Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments.;Number of cognitive tasks completed by each participant relative to the number of scheduled cognitive tasks.