AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)
NCT ID: NCT06444789
Last Updated: 2024-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
90 participants
OBSERVATIONAL
2024-09-20
2025-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Development cohort of patients with known RBD
Detection of RBD signs by using the connected smartwach during 4 weeks
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.
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
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.
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
Lack of social security.
18 Years
ALL
Yes
Sponsors
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European Union
OTHER
University Hospital Carl Gustav Carus
OTHER
Aristotle University Of Thessaloniki
OTHER
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Margherita FABBRI
Role: PRINCIPAL_INVESTIGATOR
Toulouse Hospital
Björn FALKENBURGER
Role: STUDY_CHAIR
University Hospital Carl Gustav Carus of Dresden
Locations
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Neurology Toulouse Hospital
Toulouse, , France
Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pending)
Dresden, , Germany
Hospital Ruber Internacional
Madrid, , Spain
King's college of London (Regulatory authorization pending)
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Björn FALKENBURGER
Role: primary
Monica KURTIS
Role: primary
Dhaval TRIVEDI
Role: primary
Related Links
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Related Info
Other Identifiers
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RC31/23/0184 - RC31/24/0031
Identifier Type: -
Identifier Source: org_study_id
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