REM Sleep Behavior Disorder Clinical Trial
— SEV-TCSPOfficial title:
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Société Française de Recherche et Médecine du Sommeil |
France,
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 |
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