Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06582121

Acronym

SOMPARK

Enrollment

457

Registered

2024-09-03

Start date

2025-03-18

Completion date

2028-04-01

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, REM Sleep Behavior Disorder (iRBD)

Keywords

Parkinson disease, isolated RBD, Sleep

Brief summary

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

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.

Interventions

OTHERPolysomnography

An overnight sleep study

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

France

Contacts

CONTACTIsabelle ARNULF, Prof

isabelle.arnulf@aphp.fr+33 (0)1 42 16 77 04

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026