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NCT Number: NCT06582121

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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polysomnography

Other

An overnight sleep study

Other names: Biology (urine, blood, faeces), Questionnaries, electromyogram, electroencephalogram

Primary outcomes

  1. Polysomnography to compare sleep efficiency

    Time frame: 25 months

    Using polysomnography to compare sleep efficiency in the 3 study populations during the first night

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle ARNULF, Prof

CONTACT

[email protected]

+33 (0)1 42 16 77 04

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SOMPARK

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 3, 2024
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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