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

NCT06444789 | Not Yet Recruiting

• 1 other identifier: RC31/23/0184 - RC31/24/0031
• Study Type: observational
• Target: 90
• Locations: 4 countries
• Sites: 4

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.

Conditions

Parkinson Disease

Keywords

REM sleep behaviour disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• correlation between a) and b)

  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.

  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.

  4 weeks (for development cohort) and 3 months (for confirmation cohort)

Study Arms (3)

Development cohort of patients with known RBD

Detection of RBD signs by using the connected smartwach during 4 weeks

Device: connected smartwatch

Development cohort of matched controls = people who don't have RBD age and sex matched

Detection of RBD signs by using the connected smartwach during 4 weeks

Device: connected smartwatch

Confirmation cohort of parkinson disease patients = people who are supposed to have RBD

Detection of RBD signs by using the connected smartwach during 3 months

Device: connected smartwatch

Interventions

connected smartwatch DEVICE

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

Confirmation cohort of parkinson disease patients = people who are supposed to have RBD; Development cohort of matched controls = people who don't have RBD age and sex matched; Development cohort of patients with known RBD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• European Union: collaborator
• University Hospital Carl Gustav Carus: collaborator
• Aristotle University Of Thessaloniki: collaborator

Study Sites (4)

Neurology Toulouse Hospital

Toulouse, France

Location

Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pending)

Dresden, Germany

Location

Hospital Ruber Internacional

Madrid, Spain

Location

King's college of London (Regulatory authorization pending)

London, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Margherita FABBRI

  Toulouse Hospital

  PRINCIPAL INVESTIGATOR

• Björn FALKENBURGER

  University Hospital Carl Gustav Carus of Dresden

  STUDY CHAIR

Central Study Contacts

Nadege ALGANS

CONTACT

33-561777204; algans.n@chu-toulouse.fr

Anna RIBYCKA

CONTACT

33-561778252; ribycka.a@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 6, 2024
• Study Start: September 20, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

ES (1); DE (1); GB (1); FR (1)