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French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)

NCT04071899 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2019-08-28

No results posted yet for this study

Summary

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

Conditions

  • REM Sleep Behavior Disorder

Interventions

OTHER

Scale vaidation

It's just filling a scale in order to validate it in French

Sponsors & Collaborators

  • Société Française de Recherche et Médecine du Sommeil

    collaborator UNKNOWN

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Maria-Livia Fantini · University Hospital, Clermont-Ferrand

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-24
Primary Completion
2020-06-24
Completion
2020-09-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071899 on ClinicalTrials.gov