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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02473-52 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Société Française de Recherche et Médecine du Sommeil | UNKNOWN |
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REM (Rapid Eye Movements) Sleep Behavior Disorder (RBD) is a parasomnia characterized by episodes of elaborate or violent motor activity during dreams, which can lead to injury and sleep disruption in patient and / or his/her spouse. This is due to the loss of the normal muscle atonia during REM Sleep. RBD is often associated to neurodegenerative diseases, and may even precede them for several years as an early marker. Currently, there is no scale or tool for assessing the severity of RBD. Nevertheless, it is crucial to have a tool of severity when one wants to study the natural evolution of this disorder, as well as the possible effect of a drug in the context of a clinical trial. A Severity Scale of RBD has recently been proposed within the International RBD Study Group and an international validation study in several languages is being considered.
The main objective of this study is to validate a new scale of severity of the REM sleep behavior disorder (RBD Severity Scale or RBDSS) and to characterize its metrological properties, in particular its concurrent validity, internal consistency and reproducibility
Research involving the human person, non-interventional, category 3
80 patients with RBD of any etiology (eg Idiopathic RBD, RBD associated with Parkinson's Disease, Multiple System Atrophy, Narcolepsy etc.) and their bedpartners (if available) will be include in 5 French centers (Clermont-Ferrand, Paris, Nantes, Montpellier et Lyon) Patients, and their bedpartners (if available), will be seen 2 times at 1 week intervals.
For the patients Visit 1 (Day 0): duration : 60 minutes
Visit 2 (J7) : duration : 20 minutes
At home, patients will fill :
D8 à D36 :
• Weekly Severity Agenda (wRBDQ) for 4 weeks
D36 :
Visit 2 (D7- retest) : duration : 20 minutes
At home: bedpartners will fill:
D8 à D36 :
• Weekly Severity Agenda for 4 weeks, in common with patient
D36 :
• RBDSS-BP + Impression Global Clinique-Severity scale These documents will be mailed back in a pre-payed envelop.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | patients with RBD |
| |
| Bedpartners | Subjects which are the bedpartners of patients with RBD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scale vaidation | Other | It's just filling a scale in order to validate it in French |
|
| Measure | Description | Time Frame |
|---|---|---|
| French validation of a new scale of severity of REM Sleep behavior disorder for patient | The scale contains 8 items in the patient version. Each of them focusing on one RBD symptom, are evaluated in terms of their frequency and severity. This scale was administered at Day7 to evaluate concurrent validity, internal consistency and reproducibility | Day 7 |
| French validation of a new scale of severity of REM Sleep behavior disorder for patient | The scale contains 8 items in the patient version. Each of them focusing on one RBD symptom, are evaluated in terms of their frequency and severity. This scale was administered at Day 0 to evaluate concurrent validity, internal consistency and reproducibility | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners | The scale contains 6 items in the patient version. After two introductory questions that are not scored, the scale includes items concerning the spouse's RBD symptoms and are evaluated in terms of their frequency and severity. This scale was administered at Day 7 to to evaluate concurrent validity, internal consistency and reproducibility |
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Inclusion Criteria:
RBD patients:
Exclusion Criteria:
-- RBD patients:
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Patients with RBD and their bedpartner
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | +334.73.751.195 | drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Maria-Livia Fantini | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39327269 | Derived | Fantini ML, Postuma RB, Puligheddu M, Rieu I, Venel E, Figorilli M, Cochen-DeCock V, Leclair-Visonneau L, Arnaldi D, Mattioli P, Peter-Derex L, Ricordeau F, Terzaghi M, Arnulf I, Stefani A, Videnovic A, Chirol C, Pereira B; International RBD Study Group. Validation of the International REM Sleep Behavior Disorder Study Group Symptoms Severity Scale (IRBD-SSS): a new tool to assess RBD clinical severity. J Neurol. 2024 Nov;271(11):7264-7271. doi: 10.1007/s00415-024-12702-9. Epub 2024 Sep 27. |
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| ID | Term |
|---|---|
| D020187 | REM Sleep Behavior Disorder |
| ID | Term |
|---|---|
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Day 7 |
| French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners | The scale contains 6 items in the patient version. After two introductory questions that are not scored, the scale includes items concerning the spouse's RBD symptoms and are evaluated in terms of their frequency and severity. This scale was administered at Day 0 to to evaluate concurrent validity, internal consistency and reproducibility | Day 0 |
| Evaluation of the psychometric properties of the patient scale according to the etiology of the RBD | The total pool of patients will be divided into different groups according to the etiology (RBD-Idiopathic, RBD-parkinsons disease, RBD- Multiple System Atrophy, RBD-Narcolepsy etc.) and the validity in each condition will be evaluated | Day 7 |
| Evaluation of the fluctuations in the frequency and severity of RBD symptoms and their "night-to-night" variability through the collection of daily data over a four-week period | In order to control variability of symptoms, patients and their bed partners will complete a Weekly Symptom Diary (weekly-RBD Questionnaire), measuring the frequency and severity of symptoms daily for 4 weeks to determine the fluctuation of symptoms over a long period | Day 28 |
| Evaluation of the RBD severity using Clinical Global Impression-Severity | This scale is s the only currently available measure of severity of RBD. It includes 7 categories that are from 1 to 7: Normal (no symptoms), Minimal, Light, Moderate, Marked, Severe, Very Severe | Day 7 |
| Hôpital de la Croix Rousse | Recruiting | Lyon | 69004 | France |
|
| Clinique beausoleil | Recruiting | Montpellier | 34070 | France |
|
| CHU Nantes | Recruiting | Nantes | 44000 | France |
|
| AP-HP | Recruiting | Paris | 75013 | France |
|
| D001523 |
| Mental Disorders |