Status:
RECRUITING
Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Parkinson Disease
REM Sleep Behavior Disorder (iRBD)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\'s disease (SOMPARK)
Detailed Description
Sleep disturbances are common and understudied in established or prodromal Parkinson\'s disease. The purpose of this study is to systematically and comprehensively determine the clinical character...
Eligibility Criteria
Inclusion
- 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
- Common to all groups:
- Pregnant or breastfeeding women
- Subjects under guardianship/conservatorship
- Persons deprived of liberty.
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
457 Patients enrolled
Trial Details
Trial ID
NCT06582121
Start Date
March 18 2025
End Date
April 1 2028
Last Update
May 8 2025
Active Locations (6)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
2
CHU de Lille
Lille, France, 59037
3
CHU de Lyon
Lyon, France, 69004
4
CHU de Nantes
Nantes, France, 44093