An interventional study of Quantitative mass spectrometry assay in Narcolepsy, Idiopathic Hypersomnia and Cataplexy, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic
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.
31 studies on the registry are indexed under Cataplexy; 5 are open to participants now.
This study's enrollment of 117 is close to the median of 117 across 27 interventional studies indexed under Cataplexy.
Browse Cataplexy studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
Compared within Cataplexy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Narcolepsy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ORX-A determination by quantitative mass spectrometry
Orexin-A dosage by Multiple Reaction Monitoring Mass Spectrometry
Multiple Reaction Monitoring mass spectrometry for orexin-A dosage in cerebrospinal fluid
Time frame: Day 1 (=day of inclusion)
Orexin-A dosage by radioimmunoassay
Radioimmunoassay for orexin-A dosage in cerebrospinal fluid
Time frame: Day 1
Age of onset of hypersomnia symptoms
Time frame: Day 1
Frequency of cataplexy
Time frame: Up to 24 hours
Characteristics of cataplexy
Time frame: Up to 24 hours
Average duration of cataplexy
Time frame: Up to 24 hours
Epworth sleepiness scale (ESS)
the score will be between 0 and 24, higher scores mean a worse outcome
Time frame: Day 1
Narcolepsy severity scale (NSS)
the score will be between 0 and 57, higher scores mean a worse outcome
Time frame: Day 1
Hypersomnolence severity scale (IHSS)
the score will be between 0 and 50, higher scores mean a worse outcome
Time frame: Day 1
Insomnia severity index
the score will be between 0 and 32, higher scores mean a worse outcome
Time frame: Day 1
Iterative sleep latency tests (TILE)
Time frame: Up to 24 hours
Presence of the HLA allele DQB1*06:02
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2023 to primary completion in Oct 2024, 19 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier →