Comparing two methods for measuring orexin-A in patients with excessive sleepiness
Multiple Reaction Monitoring (MRM) Versus I 125 Radioimmunoassay (RIA) for the Quantification of Orexin-A/Hypocretin-1 Levels in Cerebrospinal Fluid: a Prospective Diagnostic Validation Study in Patients With Hypersomnolence
This study is testing two different ways to measure orexin-A levels in people with excessive sleepiness to see if it helps improve diagnosis and treatment for conditions like narcolepsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 117 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05615584 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of mass spectrometry and radioimmunoassay in quantifying orexin-A levels in patients suffering from hypersomnolence, including narcolepsy and idiopathic hypersomnia. The research focuses on understanding the role of orexin deficiency in these conditions, which are characterized by excessive daytime sleepiness. Participants will undergo a lumbar puncture to collect cerebrospinal fluid for analysis, allowing researchers to assess the correlation between orexin levels and hypersomnolence symptoms. The findings could enhance diagnostic accuracy and treatment approaches for these sleep disorders.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 8 years and older who experience excessive daytime sleepiness and are suspected of having central hypersomnolence.
Not a fit: Patients with secondary hypersomnolence or those unable to undergo a lumbar puncture may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for hypersomnolence disorders, enabling better-targeted treatments.
How similar studies have performed: While the approach of measuring orexin levels is established, the specific comparison of these two methods in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 8 years * Complaint of hypersomnolence and suspected central hypersomnolence * Benefiting from a standardised assessment: clinical, biological and neurophysiological * Lumbar puncture necessary for the assessment * Sufficient cerebrospinal fluid taken for biological analysis (at least 1 ml) * Signed informed consent Exclusion Criteria: * Contraindication to lumbar puncture * Secondary hypersomnolence * Refusal to participate in the study or refusal of the lumbar puncture * Adult protected by law, or subject deprived of liberty, by judicial or administrative decision or patient under guardianship or curatorship * Subject not affiliated to the French social security system * Pregnant or breastfeeding woman
Where this trial is running
Montpellier
- University Hospital of Montpellier — Montpellier, France (Recruiting)
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.