French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)
SEV-TCSP
2 other identifiers
observational
80
1 country
5
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2019
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2019
CompletedFirst Submitted
Initial submission to the registry
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2020
CompletedAugust 28, 2019
July 1, 2019
1.1 years
July 29, 2019
August 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (5)
French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners
Day 7
French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners
Day 0
Evaluation of the psychometric properties of the patient scale according to the etiology of the RBD
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
Day 28
Evaluation of the RBD severity using Clinical Global Impression-Severity
Day 7
Study Arms (2)
Patients
patients with RBD
Bedpartners
Subjects which are the bedpartners of patients with RBD
Interventions
Eligibility Criteria
Patients with RBD and their bedpartner
You may qualify if:
- 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
You may not qualify if:
- \-- 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
- Bedpartners
- Clinically defined dementia according to the criteria of DSM-V2 (Major Neurocognitive Disorder)
- Patients under tutorship or curatorship or safeguard of justice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CHU Clermont-Ferrand
Clermont-Ferrand, 63000, France
Hôpital de la Croix Rousse
Lyon, 69004, France
Clinique beausoleil
Montpellier, 34070, France
CHU Nantes
Nantes, 44000, France
AP-HP
Paris, 75013, France
Related Publications (1)
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.
PMID: 39327269DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria-Livia Fantini
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2019
First Posted
August 28, 2019
Study Start
May 24, 2019
Primary Completion
June 24, 2020
Study Completion
September 24, 2020
Last Updated
August 28, 2019
Record last verified: 2019-07