Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease (NCT06582121) | Clinical Trial Compass
RecruitingNot Applicable
Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
France457 participantsStarted 2025-03-18
Plain-language summary
Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\'s disease (SOMPARK)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Common to all groups:
* Age superior 18 years
* Patients who have received complete information about the study from an investigator and who fully consent to participate.
For Parkinson Disease (PD):
* Patients followed for PD diagnosed according to international criteria for the diagnosis of PD (MDS criteria),
* A MoCA score greater than 20/30
* No treatment with deep brain stimulation.
For REM Sleep Behavior Disorder (RBD):
* Diagnosis of RBD according to ICSD-3 criteria: presence on polysomnography of an abnormal elevation of muscle tone during REM sleep (more than 18% of REM sleep without chin atonia) and/or the presence of REM sleep behaviors on video-polysomnography,
* Absence of progressive neurodegenerative pathology: absence of diagnostic criteria for PD, multiple system atrophy, or Lewy body dementia.
For healthy controls:
\- No neurological or psychiatric disease
Exclusion Criteria:
Common to all groups:
* Pregnant or breastfeeding women
* Subjects under guardianship/conservatorship
* Persons deprived of liberty.