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New test could sharpen diagnosis of narcolepsy and related sleep disorders

NCT ID NCT05615584

Diagnosis Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study compares a new mass spectrometry technique to the standard radioimmunoassay for measuring orexin-A levels in cerebrospinal fluid. Orexin-A is a key brain chemical that is low in people with type 1 narcolepsy. The study involves 117 people with excessive daytime sleepiness who are undergoing a lumbar puncture as part of their evaluation. If the new method proves accurate, it could provide a more reliable and widely available diagnostic tool for narcolepsy and related hypersomnia disorders.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the new mass spectrometry test proves accurate, it could offer a more accessible and reliable way to diagnose narcolepsy and other hypersomnia disorders.
What could go wrong
This is a diagnostic validation study, not a treatment trial. The new test may not be as accurate as the current method, and results may not change clinical practice immediately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

117 people

The number who actually took part.

Started

Feb 2023

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cataplexy idiopathic hypersomnia narcolepsy narcolepsy 1 narcolepsy without cataplexy narcolepsy-cataplexy syndrome Sleepiness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cataplexy Idiopathic hypersomnia Narcolepsy

Contacts and locations

Locations

  • University Hospital of Montpellier

    Montpellier, France

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