Clinical Trials in France / NCT06582121
Recruiting
Not applicable
Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
NCT06582121 · tracked via the Priya Life Science France tracker
Condition(s) studied
Parkinson DiseaseREM Sleep Behavior Disorder (iRBD)
Investigational drug(s) / intervention(s)
Polysomnography
Polysomnography: An overnight sleep study
Study summary
Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\'s disease (SOMPARK)
Eligibility
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.
Primary outcome measure(s)
- Polysomnography to compare sleep efficiency — 25 months
Using polysomnography to compare sleep efficiency in the 3 study populations during the first night
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | France | Recruiting |
| CHU de Lille | Lille | France | Recruiting |
| CHU de Lyon | Lyon | France | Recruiting |
| CHU de Nantes | Nantes | France | Recruiting |
| CHU de Nîmes | Nîmes | France | Recruiting |
| CHU Pitié Salpêtrière | Paris | France | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06582121 on ClinicalTrials.gov ↗ ← All trials in France