Ireland
--:--IST
Recruiting Not applicable

Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease

NCT06582121 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-03-18
Last updated
2026-03-06

Condition(s) studied

Parkinson DiseaseREM Sleep Behavior Disorder (iRBD)

Investigational drug(s) / intervention(s)

Polysomnography

Polysomnography: An overnight sleep study

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Polysomnography to compare sleep efficiency — 25 months
    Using polysomnography to compare sleep efficiency in the 3 study populations during the first night

Trial sites (6)

FacilityCityRegionStatus
CHU de Clermont-Ferrand Clermont-Ferrand France Recruiting
CHU de Lille Lille France Recruiting
CHU de Lyon Lyon France Recruiting
CHU de Nantes Nantes France Recruiting
CHU de Nîmes Nîmes France Recruiting
CHU Pitié Salpêtrière Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06582121 on ClinicalTrials.gov ↗ ← All trials in France