French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)
NCT ID: NCT04071899
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2019-05-24
2020-09-24
Brief Summary
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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
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Detailed Description
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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
* Information to patient and collection of non-opposition
* Collection of socio-demographic data: age, sex, level of education
* Clinical data collection: duration of RBD, duration and severity of the concomitant disease:, medical and surgical history
* Assessment of cognitive functions: Mini Mental State Examination
* Verification of inclusion / exclusion criteria
* Ongoing treatments and calculation of Levodopa Equivalent Daily Dose (LEDD) for PD patients.
* RBD severity scale for Patient (RBDSS-PT) + Global Clinical Impression-Severity Scale
Visit 2 (J7) : duration : 20 minutes
* Ongoing treatments
* RBDSS PT + Global Clinical Impression-Severity Scale (CGI-S-PT)
* Patient will be given a Weekly Severity Agenda for 4 weeks plus a copy of the RBSSS-PT + Global Clinical Impression-Severity Scale
At home, patients will fill :
D8 à D36 :
• Weekly Severity Agenda (wRBDQ) for 4 weeks
D36 :
* RBDSS-PT + Clinical Global Impression-Severity These documents will be mailed back in a pre-payed envelop. For the Bed Partners Visit 1 (D0- baseline): duration: 30 minutes
* Information of and collection of non opposition
* Collection of socio-demographic data: age, sex, level of education
* Assessment of cognitive functions: Mini Mental State Examination
* Verification of inclusion / exclusion criteria
* Ongoing Treatments
* RBD severity scale of the bed partner (RBDSS BP)+ Global Clinical Impression-Severity Scale
Visit 2 (D7- retest) : duration : 20 minutes
* Ongoing treatments
* RBDSS-BP + Clinical Overall Impression Severity Scale
* Patient will be given a Weekly Joint Severity Agenda to be completed together with the patient, (wRBDQ) for 4 weeks, plus a copy of the RBDSS-BP + CGI-S-BP
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
patients with RBD
Scale vaidation
It's just filling a scale in order to validate it in French
Bedpartners
Subjects which are the bedpartners of patients with RBD
Scale vaidation
It's just filling a scale in order to validate it in French
Interventions
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Scale vaidation
It's just filling a scale in order to validate it in French
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Years
80 Years
ALL
Yes
Sponsors
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Société Française de Recherche et Médecine du Sommeil
UNKNOWN
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Maria-Livia Fantini
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital de la Croix Rousse
Lyon, , France
Clinique beausoleil
Montpellier, , France
CHU Nantes
Nantes, , France
AP-HP
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2018-A02473-52
Identifier Type: OTHER
Identifier Source: secondary_id
RNI 2018 FANTINI (SEV-TCSP)
Identifier Type: -
Identifier Source: org_study_id
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