Status:
UNKNOWN
French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Société Française de Recherche et Médecine du Sommeil
Conditions:
REM Sleep Behavior Disorder
Eligibility:
All Genders
30-80 years
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...
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, Narcolep...
Eligibility Criteria
Inclusion
- 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
- \-- 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
Key Trial Info
Start Date :
May 24 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 24 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04071899
Start Date
May 24 2019
End Date
September 24 2020
Last Update
August 28 2019
Active Locations (5)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
2
Hôpital de la Croix Rousse
Lyon, France, 69004
3
Clinique beausoleil
Montpellier, France, 34070
4
CHU Nantes
Nantes, France, 44000