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)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

CHU de Lille

Lille, France

CHU de Lyon

Lyon, France

CHU de Nantes

Nantes, France

CHU de Nîmes

Nîmes, France

CHU Pitié Salpêtrière

Paris, France

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NCT06582121


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