Examining sleep disorders in Parkinson's disease and related conditions
Controlled, Multicenter Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
This study is testing how sleep problems affect people with Parkinson's disease and REM sleep behavior disorder to better understand their sleep patterns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 457 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 6 sites (Clermont-Ferrand and 5 other locations) |
| Trial ID | NCT06582121 on ClinicalTrials.gov |
What this trial studies
This study investigates sleep disturbances in patients with isolated REM Behavior Disorder and Parkinson's disease. It aims to systematically assess the clinical characteristics and electrophysiological patterns of major sleep disorders associated with these conditions. Participants will undergo polysomnography to gather detailed sleep data. The study includes individuals diagnosed with Parkinson's disease, those with REM sleep behavior disorder, and healthy controls for comparison.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of Parkinson's disease or isolated REM sleep behavior disorder.
Not a fit: Patients with progressive neurodegenerative diseases other than isolated RBD or Parkinson's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of sleep disorders in patients with Parkinson's disease.
How similar studies have performed: Other studies have explored sleep disorders in Parkinson's disease, but this specific approach focusing on isolated RBD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Clermont-Ferrand and 5 other locations
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CHU de Lille — Lille, France (Recruiting)
- CHU de Lyon — Lyon, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Recruiting)
- CHU Pitié Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Isabelle ARNULF, Prof
- Email: isabelle.arnulf@aphp.fr
- Phone: +33 (0)1 42 16 77 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.