Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Nov 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for measuring a substance called orexin-A in the spinal fluid of patients who experience excessive daytime sleepiness, a condition known as hypersomnolence. Orexin-A is important because low levels of this substance are linked to narcolepsy type 1, a condition characterized by extreme sleepiness and sudden muscle weakness (cataplexy). The trial aims to see if a new technique called mass spectrometry is as effective as the current standard method, known as radioimmunoassay, for measuring orexin-A levels.

To participate in this trial, candidates must be at least 8 years old and show signs of hypersomnolence that is believed to be from a central cause, meaning it's related to the brain's function. Participants will undergo a procedure called a lumbar puncture to collect spinal fluid, which is necessary for the analysis. Those who might be eligible should also be willing to give consent and have enough spinal fluid available for testing. It's important to note that individuals with certain medical conditions or those who are pregnant or breastfeeding cannot participate. This trial is currently recruiting participants, and it offers a chance to contribute to understanding and diagnosing conditions linked to excessive sleepiness.

Gender

ALL

Eligibility 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