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About
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
Full description
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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Inclusion criteria
RBD patients:
Exclusion criteria
-- RBD patients:
80 participants in 2 patient groups
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Central trial contact
Lise Laclautre
Data sourced from clinicaltrials.gov
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