Controlled, Multicenter Study of Sleep Disorders in Prodromal and Definite Parkinson's Disease

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease; REM Sleep Behavior Disorder (iRBD)
• Interventions: Other: Polysomnography

• Registration Number: NCT06582121
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Study Start: 2024-10
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 457

Inclusion Criteria

Common to all groups:

• Age > 18 years
• Patients who have received complete information about the study from an investigator and who fully consent to participate.

For Parkinson's 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

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Exclusion Criteria

Common to all groups:

• Pregnant or breastfeeding women
• Subjects under guardianship/conservatorship
• Persons deprived of liberty.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	Polysomnography	Study of the sleep with polysomnography during a 2-days stay in hospital. Other exam will be done during the 2 days.

Primary Outcome Measures

Name	Time	Method
Polysomnography to compare sleep efficiency	25 months	Using polysomnography to compare sleep efficiency in the 3 study populations during the first night

Trial Locations

Locations (6)

CHU de Nîmes; 🇫🇷 Nîmes, France

CHU Pitié Salpêtrière; 🇫🇷 Paris, France

CHU de Lyon; 🇫🇷 Lyon, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Lille; 🇫🇷 Lille, France