Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease

Last updated: May 7, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Disorders

Treatment

Polysomnography

Clinical Study ID

NCT06582121
APHP230127
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Common to all groups:

  • Age superior 18 years

  • Patients who have received complete information about the study from an investigatorand who fully consent to participate.

For Parkinson Disease (PD):

  • Patients followed for PD diagnosed according to international criteria for thediagnosis 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 anabnormal elevation of muscle tone during REM sleep (more than 18% of REM sleepwithout chin atonia) and/or the presence of REM sleep behaviors onvideo-polysomnography,

  • Absence of progressive neurodegenerative pathology: absence of diagnostic criteriafor PD, multiple system atrophy, or Lewy body dementia.

For healthy controls:

  • No neurological or psychiatric disease

Exclusion

Exclusion Criteria:

Common to all groups:

  • Pregnant or breastfeeding women

  • Subjects under guardianship/conservatorship

  • Persons deprived of liberty.

Study Design

Total Participants: 457
Treatment Group(s): 1
Primary Treatment: Polysomnography
Phase:
Study Start date:
March 18, 2025
Estimated Completion Date:
April 30, 2028

Study 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 characteristics and electrophysiologic patterns of the major sleep disorders in PD and isolated RBD.

Connect with a study center

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • CHU de Lille

    Lille, 59037
    France

    Site Not Available

  • CHU de Lyon

    Lyon, 69004
    France

    Site Not Available

  • CHU de Nantes

    Nantes, 44093
    France

    Site Not Available

  • CHU de Nîmes

    Nîmes, 30000
    France

    Site Not Available

  • CHU Pitié Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

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