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| Name | Class |
|---|---|
| European Union | OTHER |
| University Hospital Carl Gustav Carus | OTHER |
| Aristotle University Of Thessaloniki | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Development cohort of patients with known RBD | Detection of RBD signs by using the connected smartwach during 4 weeks |
| |
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| correlation between a) and b) |
|
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Inclusion Criteria for development cohort:
Group of RBD patients
Group of Healthy matched controls:
Inclusion Criteria for confirmation cohort
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.
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1 group of persons with RBD
1 group of persons without RBD
1 group of persons with Parkinson disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadege ALGANS | Contact | 33-561777204 | algans.n@chu-toulouse.fr | |
| Anna RIBYCKA | Contact | 33-561778252 | ribycka.a@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Margherita FABBRI | Toulouse Hospital | Principal Investigator |
| Björn FALKENBURGER | University Hospital Carl Gustav Carus of Dresden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Toulouse Hospital | Toulouse | France |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020187 | REM Sleep Behavior Disorder |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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) |
| 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 |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |