Clinical trial NCT04071899: French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)
Official title: French Validation of a Severity Scale in REM Sleep Behavior Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: REM Sleep Behavior Disorder
Keywords: REM Sleep Behavior Disorder
Validation scale
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Société Française de Recherche et Médecine du Sommeil
First posted: 2019-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with RBD and their bedpartner

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: French validation of a new scale of severity of REM Sleep behavior disorder for patient
timeFrame: Day 7
measure: French validation of a new scale of severity of REM Sleep behavior disorder for patient
timeFrame: Day 0
Secondary outcomes:
measure: French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners
timeFrame: Day 7
measure: French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners
timeFrame: Day 0
measure: Evaluation of the psychometric properties of the patient scale according to the etiology of the RBD
timeFrame: Day 7
measure: 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
timeFrame: Day 28
measure: Evaluation of the RBD severity using Clinical Global Impression-Severity
timeFrame: Day 7
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Montpellier
country: France
facility: Clinique beausoleil
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: AP-HP
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Maria-Livia Fantini
role: PRINCIPAL_INVESTIGATOR
References: