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

Parkinson Disease Clinical Trial

— dBM-DEV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444789
• Other study ID #: RC31/23/0184 - RC31/24/0031
• Status: Not yet recruiting
• Start date: July 15, 2024
• Est. completion date: July 15, 2025

Study information

• Verified date: June 2024
• Source: University Hospital, Toulouse
• Contact: Nadege ALGANS
• Phone: 33-561777204
• Email: algans.n[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 15, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• connected smartwatch
The smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD.

Locations

Country	Name	City	State
France	Neurology Toulouse Hospital	Toulouse
Germany	Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pending)	Dresden
Spain	Hospital Ruber Internacional	Madrid
United Kingdom	King's college of London (Regulatory authorization pending)	London

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Aristotle University Of Thessaloniki, European Union, University Hospital Carl Gustav Carus

Countries where clinical trial is conducted

France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort	4 weeks
Secondary	correlation between a) and b)	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; the score of the Epworth Sleepiness Scale at baseline, measured by the Spearman correlation coefficient, in a confirmation cohort	4 weeks for a) 3 months for b)
Secondary	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)
Secondary	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)

External Links

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