AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: connected smartwatch.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Germany, Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
AI-based Parkinson's Disease Risk Assessment and Prognosis - Digital Biomarkers Development, Validation and Verification Study (AI-PROGNOSIS dBM-DEV Study)
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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 [Time frame: 4 weeks]
Secondary outcome measures (3)
- correlation between a) and b) [Time frame: 4 weeks for a) 3 months for b)]
- Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments. [Time frame: 4 weeks (for development cohort) and 3 months (for confirmation cohort)]
- Number of cognitive tasks completed by each participant relative to the number of scheduled cognitive tasks. [Time frame: 4 weeks (for development cohort) and 3 months (for confirmation cohort)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Neurology Toulouse Hospital — Toulouse
Germany · 1 center
- Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pendi — Dresden
Spain · 1 center
- Hospital Ruber Internacional — Madrid
United Kingdom · 1 center
- King's college of London (Regulatory authorization pending) — London
Identifiers
NCT: NCT06444789 · RC31/23/0184 - RC31/24/0031