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

March 4, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

457

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • CHU de Clermont-Ferrand
        • Contact:
        • Principal Investigator:
          • Maria-Livia FANTINI, MD
      • Lille, France, 59037
        • Recruiting
        • CHU de Lille
        • Contact:
        • Principal Investigator:
          • Lise LANVIN, MD
      • Lyon, France, 69004
        • Recruiting
        • CHU de Lyon
        • Contact:
        • Principal Investigator:
          • Laure PETER-DEREX, MD
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
        • Principal Investigator:
          • Laurène LECLAIR-VISONNEAU, MD
        • Contact:
      • Nîmes, France, 30000
        • Recruiting
        • CHU de Nîmes
        • Contact:
        • Principal Investigator:
          • Beatriz ABRIL, MD
      • Paris, France, 75013
        • Recruiting
        • CHU Pitie Salpetriere
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pauline DODET, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants
Study of the sleep with polysomnography during a 2-days stay in hospital. Other exam will be done during the 2 days.
Other: Polysomnography
An overnight sleep study
Other Names:
  • electroencephalogram
  • Biology (urine, blood, faeces)
  • Questionnaries
  • electromyogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography to compare sleep efficiency
Time Frame: 25 months
Using polysomnography to compare sleep efficiency in the 3 study populations during the first night
25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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