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

Primary Purpose

Narcolepsy, Idiopathic Hypersomnia, Cataplexy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Quantitative mass spectrometry assay
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Narcolepsy focused on measuring orexin/hypocretin, sleepiness

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Orexin-A dosage by Multiple Reaction Monitoring Mass Spectrometry
    Multiple Reaction Monitoring mass spectrometry for orexin-A dosage in cerebrospinal fluid
    Orexin-A dosage by radioimmunoassay
    Radioimmunoassay for orexin-A dosage in cerebrospinal fluid

    Secondary Outcome Measures

    Age of onset of hypersomnia symptoms
    Frequency of cataplexy
    Characteristics of cataplexy
    Average duration of cataplexy
    Epworth sleepiness scale (ESS)
    the score will be between 0 and 24, higher scores mean a worse outcome
    Narcolepsy severity scale (NSS)
    the score will be between 0 and 57, higher scores mean a worse outcome
    Hypersomnolence severity scale (IHSS)
    the score will be between 0 and 50, higher scores mean a worse outcome
    Insomnia severity index
    the score will be between 0 and 32, higher scores mean a worse outcome
    Iterative sleep latency tests (TILE)
    Presence of the HLA allele DQB1*06:02

    Full Information

    First Posted
    October 26, 2022
    Last Updated
    November 7, 2022
    Sponsor
    University Hospital, Montpellier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05615584
    Brief Title
    Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence
    Acronym
    MRM-OREX
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 30, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2025 (Anticipated)
    Study Completion Date
    October 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Narcolepsy, Idiopathic Hypersomnia, Cataplexy
    Keywords
    orexin/hypocretin, sleepiness

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    117 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Quantitative mass spectrometry assay
    Intervention Description
    ORX-A determination by quantitative mass spectrometry
    Primary Outcome Measure Information:
    Title
    Orexin-A dosage by Multiple Reaction Monitoring Mass Spectrometry
    Description
    Multiple Reaction Monitoring mass spectrometry for orexin-A dosage in cerebrospinal fluid
    Time Frame
    Day 1 (=day of inclusion)
    Title
    Orexin-A dosage by radioimmunoassay
    Description
    Radioimmunoassay for orexin-A dosage in cerebrospinal fluid
    Time Frame
    Day 1
    Secondary Outcome Measure Information:
    Title
    Age of onset of hypersomnia symptoms
    Time Frame
    Day 1
    Title
    Frequency of cataplexy
    Time Frame
    Up to 24 hours
    Title
    Characteristics of cataplexy
    Time Frame
    Up to 24 hours
    Title
    Average duration of cataplexy
    Time Frame
    Up to 24 hours
    Title
    Epworth sleepiness scale (ESS)
    Description
    the score will be between 0 and 24, higher scores mean a worse outcome
    Time Frame
    Day 1
    Title
    Narcolepsy severity scale (NSS)
    Description
    the score will be between 0 and 57, higher scores mean a worse outcome
    Time Frame
    Day 1
    Title
    Hypersomnolence severity scale (IHSS)
    Description
    the score will be between 0 and 50, higher scores mean a worse outcome
    Time Frame
    Day 1
    Title
    Insomnia severity index
    Description
    the score will be between 0 and 32, higher scores mean a worse outcome
    Time Frame
    Day 1
    Title
    Iterative sleep latency tests (TILE)
    Time Frame
    Up to 24 hours
    Title
    Presence of the HLA allele DQB1*06:02
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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