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

NCT ID: NCT05615584

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2025-10-30

Brief Summary

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

Narcolepsy; Idiopathic Hypersomnia; Cataplexy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Quantitative mass spectrometry assay

ORX-A determination by quantitative mass spectrometry

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Lucie BARATEAU

Role: primary

l-barateau@chu-montpellier.fr

0467333165

Other Identifiers

RECHMPL22_0072

Identifier Type: -

Identifier Source: org_study_id