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

Phase

N/A

Condition

Sleep Disorders

Treatment

N/A

Clinical Study ID

NCT04071899

RNI 2018 FANTINI (SEV-TCSP)

2018-A02473-52

Ages 30-80
All Genders
Accepts Healthy Volunteers

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

RBD patients:
Men or women aged 30 to 80
Patients with idiopathic and secondary RBD (including RBD associated withParkinson's disease, Narcolepsy, Multiple System Atrophy or other neurologicaldiseases) diagnosed according to the latest international criteria Classificationof Sleep Disorders (ICSD-3 ).
Cooperation and understanding to strictly comply with the conditions laid down inthe 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 describedin the protocol
Affiliated to a social security system

Exclusion

Exclusion Criteria:

-- RBD patients:

Clinically defined dementia according to the criteria of DSM-V2 (Major NeurocognitiveDisorder)
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 inthe study and no change in treatment should be expected a priori within one week ofinclusion
Bedpartners
Clinically defined dementia according to the criteria of DSM-V2 (Major NeurocognitiveDisorder)
Patients under tutorship or curatorship or safeguard of justice

Study Design

May 24, 2019

September 24, 2020

Study 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

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.

Connect with a study center

CHU Clermont-Ferrand
Clermont-Ferrand, 63000
France
Active - Recruiting
Hôpital de la Croix Rousse
Lyon, 69004
France
Active - Recruiting
Clinique beausoleil
Montpellier, 34070
France
Active - Recruiting
CHU Nantes
Nantes, 44000
France
Active - Recruiting
AP-HP
Paris, 75013
France
Active - Recruiting

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