Clinical Trials Logo

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04071899
Study type Observational
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone +334.73.751.195
Email drci@chu-clermontferrand.fr
Status Recruiting
Phase
Start date May 24, 2019
Completion date September 24, 2020

See also
  Status Clinical Trial Phase
Completed NCT03671772 - Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the FDRs of Patients With RBD
Recruiting NCT05109364 - Terazosin and Parkinson's Disease Extension Study Phase 2
Recruiting NCT03288909 - Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease
Completed NCT04006925 - Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate Phase 4
Completed NCT03353207 - Striatal Dopamine Transmission in Individuals With Isolated Rapid Eye Movement Sleep With Atonia: a Search for Precursor Biomarker for Neurodegeneration
Completed NCT02824341 - Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder N/A
Recruiting NCT03671798 - Establish a National Registry of REM Sleep Behavior Disorder
Enrolling by invitation NCT01453127 - DaTSCAN Imaging in Aging and Neurodegenerative Disease Phase 4
Terminated NCT02871427 - Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder Phase 2
Completed NCT03595475 - Prodromal Markers of First-degree Relatives of Patients With Psychiatric Disorders Comorbid With RBD
Recruiting NCT03660982 - Familial Aggregation and Biomarkers in REM Sleep Behaviour Disorder.
Completed NCT03255642 - Efficacy and Safety of Melatonin and Clonazepam for IRBD N/A
Recruiting NCT05904717 - Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder Phase 2
Not yet recruiting NCT06140511 - DREAMER - IsolateD REM Sleep Without Atonia as a Risk Factor for REM Sleep Behavior disordER
Recruiting NCT04386317 - Terazosin Effect on Cardiac Changes in Early Parkinson's Disease Phase 2
Enrolling by invitation NCT05514106 - MIBG in Aging and Neurologic Disorders Phase 4
Completed NCT03645226 - Gut Microbiota Across Early Stages of Synucleinopathy: From High-risk Relatives, REM Sleep Behavior Disorder to Early Parkinson's Disease
Recruiting NCT05262543 - PREdictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study
Recruiting NCT04048603 - Search for Biomarkers of Neurodegenerative Diseases in Idiopathic REM Sleep Behavior Disorder
Completed NCT02708186 - Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD) Phase 2