Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-18

Study Completion Date

2028-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Parkinson Disease REM Sleep Behavior Disorder (iRBD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participant will do polysomnographies during a 2-days stay in hospital with electroencephalogram, electromyogram and questionnaries. The urine will be also collected during 2 days.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Participants

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

Group Type EXPERIMENTAL

Polysomnography

Intervention Type OTHER

An overnight sleep study

Interventions

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Polysomnography

An overnight sleep study

Intervention Type OTHER

Other Intervention Names

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Biology (urine, blood, faeces) Questionnaries electromyogram electroencephalogram

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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