Trials
Search / Trial NCT06444789

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

Launched by UNIVERSITY HOSPITAL, TOULOUSE · May 30, 2024

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

Rem Sleep Behaviour Disorder

ClinConnect Summary

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.

Gender

ALL

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.

Trial Officials

Margherita FABBRI

Principal Investigator

Toulouse Hospital

Björn FALKENBURGER

Study Chair

University Hospital Carl Gustav Carus of Dresden

About University Hospital, Toulouse

The University Hospital of Toulouse is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the hospital integrates cutting-edge scientific inquiry with comprehensive clinical services. Its multidisciplinary team of healthcare professionals collaborates with renowned researchers to facilitate pioneering studies across various medical fields, aiming to enhance treatment options and improve patient outcomes. As a prominent institution in the region, the University Hospital of Toulouse is committed to fostering an environment of excellence in both education and research within the healthcare community.

Locations

Madrid, , Spain

Toulouse, , France

Dresden, , Germany

London, , United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0