Clinical trial NCT06444789: AI-PROGNOSIS - Digital Biomarkers Development Study (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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parkinson Disease
Keywords: REM sleep behaviour disorder
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: European Union
name: University Hospital Carl Gustav Carus
name: Aristotle University Of Thessaloniki
First posted: 2024-06-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1 group of persons with RBD

1 group of persons without RBD

1 group of persons with Parkinson disease

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.

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.

Primary outcomes:
measure: 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
timeFrame: 4 weeks
Secondary outcomes:
measure: correlation between a) and b)
timeFrame: 4 weeks for a) 3 months for b)
measure: Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments.
timeFrame: 4 weeks (for development cohort) and 3 months (for confirmation cohort)
measure: Number of cognitive tasks completed by each participant relative to the number of scheduled cognitive tasks.
timeFrame: 4 weeks (for development cohort) and 3 months (for confirmation cohort)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Neurology Toulouse Hospital
city: Dresden
country: Germany
facility: Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pending)
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: London
country: United Kingdom
facility: King's college of London (Regulatory authorization pending)
Study officials:
affiliation: Toulouse Hospital
name: Margherita FABBRI
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Carl Gustav Carus of Dresden
name: Björn FALKENBURGER
role: STUDY_CHAIR
References: