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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
France
CHU de Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
CHU de Lille
NOT_YET_RECRUITING
Lille
CHU de Lyon
NOT_YET_RECRUITING
Lyon
CHU de Nantes
NOT_YET_RECRUITING
Nantes
CHU de Nîmes
NOT_YET_RECRUITING
Nîmes
CHU Pitié Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Isabelle ARNULF, Prof
isabelle.arnulf@aphp.fr
+33 (0)1 42 16 77 04
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2028-04
Participants
Target number of participants: 457
Treatments
Experimental: Participants
Study of the sleep with polysomnography during a 2-days stay in hospital. Other exam will be done during the 2 days.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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