ClinicalTrials.gg
CompletedNCT05967832NARCO7TUpdated Oct 21, 2026

Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy

An interventional study of 7T MRI in Narcolepsy Type 1, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

Updated Oct 21, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 47 studies in Narcolepsy with a site in France — 10 open to participants now, 11 under way, 4 of them phase 3. Narcolepsy · France.

Enrollment
34th of 37
30 · median 102
Started
2024
with 6 others
No phase
10 of 47
2 open now
Registered
32nd of 47
by date
Lead sponsor
1 of 47
Assistance Publique Hopitaux De Marseille

Among the 47 studies in Narcolepsy with a site in France, this one is the 34th largest by enrollment of the 37 interventional ones, is one of 7 that started in 2024, is one of 10 with no phase, and was the 32nd registered.

By phase

47 studies; the count open now beside each. This study's row is marked.

Phase 315 · 1 open
No phasethis study10 · 2 open
Observational10 · 3 open
Phase 29 · 2 open
Phase 2/32 · 2 open
Phase 41 · 0 open

By the year they started

First in 2003; this study’s year is marked. 7 started in 2024.

Size and results

Median enrollment 102 across the 37 interventional studies, 120 across the 10 observational. Of the 34 that completed or were terminated, 16 (47%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 47 studies in Narcolepsy with a site in France, or all of them as a file.
02

Study summary

This study is part of the research on type 1 narcolepsy, a neurological pathology affecting mostly young subjects. The only biomarker currently available is the hypocretin assay, which shows a level below 110 pg/mL. However, the interpretation of this biomarker has limitations: the test is not widely available and it is rarely performed by practitioners. Even when performed, the interpretation of the level may not be consistent with the phenotype compatible with type 1 narcolepsy.

This study therefore aims to develop new tools to reduce the diagnostic delay. This would be the first study with 7T MRI that could achieve a level of spatial resolution sufficient to highlight volume changes in small brain structures such as the lateral hypothalamus whose narcolepsy-induced changes are not detected by lower resolution MRI.

03

Conditions studied

  • Narcolepsy Type 1

Browse trials for

Keywords

  • narcolepsy
  • 7T MRI
  • hypothalamus
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for patients :

  1. Diagnosis of narcolepsy type 1 according to the diagnostic criteria of the International Classification of sleep disorders version 3 (ICSD-3, American Academy of Sleep Medicine, 2014) including a mean sleep latency of less than 8 minutes on the iterative sleep latency test associated with at least two direct REM sleep onset and the presence of cataplexy, and a cerebrospinal fluid hypocretin assay of less than 110 pg/ml performed by the reference radioimmunology (RIA) technique.
  2. Patient at least 18 years old
  3. Patient followed at the Narcolepsy and Rare Hypersomnias Competence Center, Timone Hospital, Marseille
  4. Patient having signed an
  5. Patient who is a beneficiary of or affiliated to a social security system

Exclusion Criteria for patient:

  1. Diagnosis of type 1 narcolepsy according to ICSD-3 criteria but without hypocretin assay
  2. Narcolepsy secondary to another neurological pathology or presence of a comorbid neurological pathology (multiple sclerosis, Steinert's myotonic dystrophy, head trauma, epilepsy)
  3. Protected patient: pregnant or breastfeeding woman, adult under guardianship or curatorship
  4. to the realization of a 7T MRI: patient wearing a pacemaker, neurosurgical clips, artificial heart valve, surgical material or metal fragments in the body, dental or hearing prostheses, insulin pump, patient wearing an IUD, claustrophobic patient
  5. Patient unable to maintain decubitus position for the duration of the MRI (= 50 minutes)

Inclusion criteria for healthy volunteers:

  1. Subject 18 years of age or older
  2. Subject free of general illness, psychiatric disorders, and infectious, inflammatory, tumor, vascular, degenerative, or traumatic pathology of the central nervous system as determined during the medical interview.
  3. Subject who has signed an informed consent ;
  4. Subjects who are beneficiaries of or affiliated with a social security plan

Exclusion criteria for healthy volunteers:

  1. Protected subject: pregnant or breastfeeding woman, adult under guardianship or curatorship
  2. Subjects presenting a contraindication to the realization of a 7T MRI: patient with a pacemaker, neurosurgical clips, artificial heart valve, surgical material or metal fragments in the body, dental or auditory prostheses, insulin pump, patient with an IUD, claustrophobic patient
  3. Subject unable to maintain a decubitus position for the duration of the MRI (= 50 minutes)
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Patients with type 1 narcolepsy

    Patients with type 1 narcolepsy

    Other: 7T MRI

  • Active comparator
    Healthy volunteers

    Other: 7T MRI

Interventions

  • Other7T MRI

    Patients and healthy volunteers will have a 7T MRI

06

What researchers measure

Primary outcomes

  1. Hypothalamic morphological difference

    Significant structural size difference between right and left lateral hypothalamus

    Time frame: Month 0

Secondary outcomes

  1. Microstructural abnormalities other than volume differences

    Significant difference in Diffusion and T2\* values in the lateral hypothalamus

    Time frame: Month 0

  2. Structural changes in hypothalamic nuclei other than the lateral hypothalamus

    Significant difference in volumes and T1 values in other regions of the posterior hypothalamus

    Time frame: Month 0

07

Study locations

1 site
  • Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil
    Marseille, 13005, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Jan 2026, 23 months.

Of 21 interventional studies with no phase under Narcolepsy, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's 23 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2023
First posted
Aug 1, 2023
StartActual
Jan 29, 2024
Primary completionActual
Jan 22, 2026
CompletionActual
Jan 22, 2026
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 21, 2026
Primary completion
Jan 29, 2026→Jan 22, 2026 (actual)
Oct 21, 2026
Study completion
Jan 29, 2026→Jan 22, 2026 (actual)
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    Recruiting→Completed
    Primary completion Jan 29, 2026→Jan 22, 2026 (now actual)
    Study completion Jan 29, 2026→Jan 22, 2026 (now actual)
    + 4 other changes: verification date, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05967832
Responsible party
Sponsor
First posted
Aug 1, 2023
Start date
Jan 29, 2024
Primary completion
Jan 22, 2026
Completion
Jan 22, 2026
Last update
Oct 21, 2026

Study contacts

François Crémieux
study director · AP-HM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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