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Recruiting NCT06582121

Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease

No phase Interventional Parkinson Disease REM Sleep Behavior Disorder (iRBD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polysomnography.
Who it may be relevant to
Registry conditions: Parkinson Disease, REM Sleep Behavior Disorder (iRBD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Controlled, Multicenter Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease

Overview

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

Interventions

  • Other Polysomnography
    An overnight sleep study

Primary outcome measures

  • Polysomnography to compare sleep efficiency [Time frame: 25 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 6 centers
  • CHU de Clermont-Ferrand — Clermont-Ferrand
  • CHU de Lille — Lille
  • CHU de Lyon — Lyon
  • CHU de Nantes — Nantes
  • CHU de Nîmes — Nîmes
  • CHU Pitié Salpêtrière — Paris

Identifiers

NCT: NCT06582121 · APHP230127

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗