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

NCT06444789 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2024-08-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • University Hospital Carl Gustav Carus

    collaborator OTHER

  • Aristotle University Of Thessaloniki

    collaborator OTHER

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Margherita FABBRI · Toulouse Hospital

  • Björn FALKENBURGER · University Hospital Carl Gustav Carus of Dresden

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2025-07-15
Completion
2025-07-15

Countries

  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06444789 on ClinicalTrials.gov