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

Not yet recruiting

• Conditions: Parkinson Disease

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

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-30
• Study First Posted: 2024-06-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Start: 2024-09-20
• Primary Completion: 2025-07-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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	4 weeks	the digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort

Secondary Outcome Measures

Name	Time	Method
Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments.	4 weeks (for development cohort) and 3 months (for confirmation cohort)
correlation between a) and b)	4 weeks for a) 3 months for b)	1. the incidence of daytime somnolence episodes per week indicated by a score (digital biomarker) derived from passive actigraphy and photoplethysmography data captured by a smartwatch. The digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort; 2. the score of the Epworth Sleepiness Scale at baseline, measured by the Spearman correlation coefficient, in a confirmation cohort
Number of cognitive tasks completed by each participant relative to the number of scheduled cognitive tasks.	4 weeks (for development cohort) and 3 months (for confirmation cohort)

Trial Locations

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