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

August 27, 2019 updated by: University Hospital, Clermont-Ferrand

French Validation of a Severity Scale in REM Sleep Behavior Disorder

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • CHU Clermont-Ferrand
        • Contact:
        • Principal Investigator:
          • Maria Livia Fantini
      • Lyon, France, 69004
        • Recruiting
        • Hopital de La Croix Rousse
        • Contact:
        • Principal Investigator:
          • Laure PETER-DEREX
      • Montpellier, France, 34070
        • Recruiting
        • Clinique BEAUSOLEIL
        • Contact:
        • Principal Investigator:
          • Valérie COCHEN DE COCK
      • Nantes, France, 44000
      • Paris, France, 75013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with RBD and their bedpartner

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
patients with RBD
Other: 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
Other: Scale vaidation
It's just filling a scale in order to validate it in French

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
French validation of a new scale of severity of REM Sleep behavior disorder for patient
Time Frame: Day 7
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
Time Frame: Day 0
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners
Time Frame: Day 7
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
French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners
Time Frame: Day 0
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
Evaluation of the psychometric properties of the patient scale according to the etiology of the RBD
Time Frame: Day 7
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
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
Time Frame: Day 28
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
Evaluation of the RBD severity using Clinical Global Impression-Severity
Time Frame: Day 7
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Société Française de Recherche et Médecine du Sommeil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2019

Primary Completion (Anticipated)

June 24, 2020

Study Completion (Anticipated)

September 24, 2020

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2018 FANTINI (SEV-TCSP)
  • 2018-A02473-52 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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