REM Sleep Behavior Disorder Clinical Trial
Official 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
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.
;
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 |