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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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