Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease

NCT06582121 — Not applicable, Recruiting, 457 participants, Assistance Publique - Hôpitaux de Paris

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

RegistryNCT06582121, acronym SOMPARK
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
Enrollment457 (Estimated)
SponsorAssistance Publique - Hôpitaux de Paris (Other)
ConditionsParkinson Disease, REM Sleep Behavior Disorder (iRBD)
InterventionsPolysomnography (Other)
Datesstart 2025-03-18, primary completion 2028-04-01 (estimated), completion 2028-04-01 (estimated), first posted 2024-09-03, last updated 2026-03-06
Locations6 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Parkinson Disease All trials for REM Sleep Behavior Disorder (iRBD) All trials of Polysomnography

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
ParticipantsExperimentalOther: PolysomnographyStudy of the sleep with polysomnography during a 2-days stay in hospital. Other exam will be done during the 2 days.
  • Polysomnography (Other), also known as Biology (urine, blood, faeces), Questionnaries, electromyogram, electroencephalogram: An overnight sleep study

+Outcome measures

Primary outcomes

  • Polysomnography to compare sleep efficiency [25 months]: Using polysomnography to compare sleep efficiency in the 3 study populations during the first night

+Eligibility

Sex: All, ages: 18 Years to any, 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.

+Locations (6)

FacilityCityCountryStatus
CHU de Clermont-FerrandClermont-FerrandFranceRecruiting
CHU de LilleLilleFranceRecruiting
CHU de LyonLyonFranceRecruiting
CHU de NantesNantesFranceRecruiting
CHU de NîmesNîmesFranceRecruiting
CHU Pitié SalpêtrièreParisFranceRecruiting