Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease

NCT06582121 | Recruiting

• 1 other identifier: APHP230127
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Parkinson Disease; REM Sleep Behavior Disorder (iRBD)

Keywords

Parkinson disease; isolated RBD; Sleep

Outcome Measures

Primary Outcomes (1)

• Polysomnography to compare sleep efficiency

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

  25 months

Study Arms (1)

Participants

EXPERIMENTAL

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

Other: Polysomnography

Interventions

Polysomnography OTHER

An overnight sleep study

Also known as: Biology (urine, blood, faeces), Questionnaries, electromyogram, electroencephalogram

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Common to all groups:
• Pregnant or breastfeeding women
• Subjects under guardianship/conservatorship
• Persons deprived of liberty.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (6)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CHU de Lille

Lille, 59037, France

RECRUITING

CHU de Lyon

Lyon, 69004, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

CHU de Nîmes

Nîmes, 30000, France

RECRUITING

CHU Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder

Interventions

Biological Factors; Urination; Blood Specimen Collection; Defecation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Isabelle ARNULF, Prof

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: March 18, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)