Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease (SOMPARK)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Parkinson Disease; REM Sleep Behavior Disorder (iRBD)

Treatments: Other: Polysomnography

Study type: Interventional

Funder types: Other

Identifiers

NCT06582121

APHP230127

Details and patient eligibility

About

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

Full 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.

Enrollment: 457 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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457 participants in 1 patient group

Participants

Experimental group

Description:

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

Treatment:

Other: Polysomnography