Actively Recruiting

Phase Not Applicable
Age: 8Years +
All Genders
NCT05615584

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

Age: 8Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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