Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444789
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-14
Brief Title:
AI-PROGNOSIS - Digital Biomarkers Development Study dBM-DEV
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
AI-based Parkinsons Disease Risk Assessment and Prognosis - Digital Biomarkers Development Validation and Verification Study AI-PROGNOSIS dBM-DEV Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
dBM-DEV
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 Parkinsons 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 dataThe 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None