Clinical trial: French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP) (NCT04071899)

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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 25-year-old woman comes to the clinic with her roommate.  The roommate says that the patient has twice fallen asleep while they were talking.  The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap.  She also reveals that she sometimes hears a voice prior to falling asleep.  She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately.

Patient description (patient's own words): I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep.

Does the patient match the trial criteria? Entailment