RecruitingNot ApplicableNCT06582121
Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
Controlled, Multicenter Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
457 participants
Start Date
Mar 18, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\'s disease (SOMPARK)
Eligibility
Min Age: 18 Years
Inclusion Criteria12
- 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 Criteria4
- Common to all groups:
- Pregnant or breastfeeding women
- Subjects under guardianship/conservatorship
- Persons deprived of liberty.
Interventions
OTHERPolysomnography
An overnight sleep study
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06582121
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