Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease

Recruiting now · Not applicable

Conditions studied: Parkinson Disease, REM Sleep Behavior Disorder (iRBD)

In brief

Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\'s disease (SOMPARK)

Key facts

Study ID

NCT06582121

Run by

Assistance Publique - Hôpitaux de Paris

People needed

457

Starts

2025-03-18

Expected to finish

2028-04-01

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Common to all groups:
• Pregnant or breastfeeding women
• Subjects under guardianship/conservatorship
• Persons deprived of liberty.

Where it is running

• CHU de Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
• CHU de Lille — Lille, France (enrolling)
• CHU de Lyon — Lyon, France (enrolling)
• CHU de Nantes — Nantes, France (enrolling)
• CHU de Nîmes — Nîmes, France (enrolling)
• CHU Pitié Salpêtrière — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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