Actively Recruiting
Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence
Led by University Hospital, Montpellier · Updated on 2024-05-29
117
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome. The International Classification of Sleep Disorders 3rd edition (ICSD-3) distinguishes between hypersomnolence of central origin: NT1, narcolepsy type 2 (NT2), or narcolepsy without cataplexy, and idiopathic hypersomnia (HI). These rare conditions are all characterised by hypersomnolence (excessive daytime sleepiness, or excessive need for sleep), which is the primary and often most disabling symptom. A level of ORX-A in cerebrospinal fluid (CSF) (\<110 pg/mL) is a very sensitive and specific biomarker of NT1, currently sufficient for the diagnosis of this condition. In contrast, ORX neurons are thought to be intact in IH and NT2, and the pathophysiological mechanisms underlying these diseases remain unknown. Thus, their diagnosis is based solely on clinical and electrophysiological criteria. The objective of this project is to determine the validity of a mass spectrometric technique for the determination of ORX-A in the cerebral spinal fluid of patients suffering from hypersomnolence in comparison with the radioimmunoassay which is the reference technique.
CONDITIONS
Official Title
Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8 years
- Complaint of hypersomnolence and suspected central hypersomnolence
- Undergoing standardized clinical, biological, and neurophysiological assessment
- Lumbar puncture required for assessment
- At least 1 ml of cerebrospinal fluid collected for analysis
- Signed informed consent
You will not qualify if you...
- Contraindication to lumbar puncture
- Secondary hypersomnolence
- Refusal to participate or refusal of lumbar puncture
- Adults protected by law, or subjects deprived of liberty by judicial or administrative decision, or under guardianship or curatorship
- Not affiliated with the French social security system
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Montpellier
Montpellier, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
0
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