Cohort for chronic sleep disorders causing excessive daytime sleepiness
Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence
This study is trying to learn more about the causes of excessive daytime sleepiness in people with chronic sleep disorders to help improve their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT03998020 on ClinicalTrials.gov |
What this trial studies
This study aims to create a comprehensive clinical, neurophysiological, and biological cohort for individuals suffering from chronic sleep disorders that lead to excessive daytime sleepiness. It focuses on understanding the various pathophysiological mechanisms behind hypersomnolence, which can be secondary to conditions like restless leg syndrome, parasomnias, or Attention-Deficit/Hyperactivity Disorder. Participants will undergo assessments including severity scales and blood samples to gather data that may help elucidate the underlying causes of their symptoms. The goal is to improve the understanding and treatment of these debilitating conditions.
Who should consider this trial
Good fit: Ideal candidates are individuals experiencing chronic hypersomnolence, identified by a sleep specialist, who may or may not have a diagnosed chronic sleep disorder.
Not a fit: Patients who are incarcerated, living in medical institutions, or do not have a social security system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and treatment options for patients suffering from chronic sleep disorders and hypersomnolence.
How similar studies have performed: While there have been studies on chronic sleep disorders, this cohort approach focusing on multiple pathophysiological mechanisms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a complaint of chronic hypersomnolence on questioning, identified by a sleep specialist and requiring objective explorations in the Centre de Hypersomnias Rares, with or without a diagnosis of chronic sleep disorder according to the International Classification scale in force at the time of diagnosis * can be treated or not for chronic sleep disorder. * speak and understand french * should have a social security system * should not have infectious or inflammatory pathology Exclusion Criteria: * be private of liberty * live in medical institution * be a major protected by law * not have social security system * refuse to participate in protocol
Where this trial is running
Montpellier
- UH Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Pôle Recherche et Innovation
- Email: depotac@chu-montpellier.fr
- Phone: 0033467330913
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.