Informations générales (source: ClinicalTrials.gov)
French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)
Observational
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
mai 2019
septembre 2020
29 juin 2024
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
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Clermont-Ferrand - 63000 - Clermont-Ferrand - France | Maria Livia Fantini | Contact (sur clinicalTrials) | |||
| CHU Nantes - 44000 - Nantes - France | Laurène LECLAIR-VISONNEAU | Contact (sur clinicalTrials) | |||
| Clinique beausoleil - 34070 - Montpellier - France | Valérie COCHEN DE COCK | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - 75013 - Paris - France | Isabelle Arnulf | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix Rousse - 69004 - Lyon - France | Laure PETER-DEREX | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- RBD patients:
- Men or women aged 30 to 80
- Patients with idiopathic and secondary RBD (including RBD associated with
Parkinson's disease, Narcolepsy, Multiple System Atrophy or other neurological
diseases) diagnosed according to the latest international criteria
Classification of Sleep Disorders (ICSD-3 ).
- Cooperation and understanding to strictly comply with the conditions laid down
in the protocol
- Affiliated to a social security system
- bedpartners
- Men or women aged 30 to 80
- Subjects sharing the same bed as the patient for ≥70% of the time (e.g. at
least 5 nights / week, or 20 nights / month)
- -Cooperation and understanding to strictly comply with the conditions described
in the protocol
- Affiliated to a social security system
- RBD patients:
- Men or women aged 30 to 80
- Patients with idiopathic and secondary RBD (including RBD associated with
Parkinson's disease, Narcolepsy, Multiple System Atrophy or other neurological
diseases) diagnosed according to the latest international criteria
Classification of Sleep Disorders (ICSD-3 ).
- Cooperation and understanding to strictly comply with the conditions laid down
in the protocol
- Affiliated to a social security system
- bedpartners
- Men or women aged 30 to 80
- Subjects sharing the same bed as the patient for ≥70% of the time (e.g. at
least 5 nights / week, or 20 nights / month)
- -Cooperation and understanding to strictly comply with the conditions described
in the protocol
- Affiliated to a social security system
-- RBD patients:
- Clinically defined dementia according to the criteria of DSM-V2 (Major
Neurocognitive Disorder)
- Untreated Obstructive Sleep Apnea Syndrome (OSAS) (with IAH> 15 / h at vPSG)
- Patients under tutorship or curatorship or safeguard of justice
- No change in treatment should have occurred during the 4 weeks prior to inclusion in
the study and no change in treatment should be expected a priori within one week of
inclusion
- Bedpartners
- Clinically defined dementia according to the criteria of DSM-V2 (Major
Neurocognitive Disorder)
- Patients under tutorship or curatorship or safeguard of justice