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

REM Sleep Behavior Disorder Clinical Trial

— SEV-TCSP  

Official title:

French Validation of a Severity Scale in REM Sleep Behavior Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071899
• Other study ID #: RNI 2018 FANTINI (SEV-TCSP)
• Secondary ID: 2018-A02473-52
• Status: Recruiting
• Start date: May 24, 2019
• Est. completion date: September 24, 2020

Study information

• Verified date: July 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: +334.73.751.195
• Email: drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

-- 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

• 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

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• REM Sleep Behavior Disorder

Intervention

Other:
• Scale vaidation
It's just filling a scale in order to validate it in French

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Hôpital de la Croix Rousse	Lyon
France	Clinique beausoleil	Montpellier
France	CHU Nantes	Nantes
France	AP-HP	Paris

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Société Française de Recherche et Médecine du Sommeil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners	The scale contains 6 items in the patient version. After two introductory questions that are not scored, the scale includes items concerning the spouse's RBD symptoms and are evaluated in terms of their frequency and severity. This scale was administered at Day 7 to to evaluate concurrent validity, internal consistency and reproducibility	Day 7
Secondary	French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners	The scale contains 6 items in the patient version. After two introductory questions that are not scored, the scale includes items concerning the spouse's RBD symptoms and are evaluated in terms of their frequency and severity. This scale was administered at Day 0 to to evaluate concurrent validity, internal consistency and reproducibility	Day 0
Secondary	Evaluation of the psychometric properties of the patient scale according to the etiology of the RBD	The total pool of patients will be divided into different groups according to the etiology (RBD-Idiopathic, RBD-parkinsons disease, RBD- Multiple System Atrophy, RBD-Narcolepsy etc.) and the validity in each condition will be evaluated	Day 7
Secondary	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	In order to control variability of symptoms, patients and their bed partners will complete a Weekly Symptom Diary (weekly-RBD Questionnaire), measuring the frequency and severity of symptoms daily for 4 weeks to determine the fluctuation of symptoms over a long period	Day 28
Secondary	Evaluation of the RBD severity using Clinical Global Impression-Severity	This scale is s the only currently available measure of severity of RBD. It includes 7 categories that are from 1 to 7: Normal (no symptoms), Minimal, Light, Moderate, Marked, Severe, Very Severe	Day 7