Narcolepsy Type 1NARCO7TNCT05967832
Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy
A study testing 7T MRI in people with Narcolepsy Type 1, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy Type 1
- What is being tested?
- 7T MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2024to 22 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Patient at least 18 years old
- Patient followed at the Narcolepsy and Rare Hypersomnias Competence Center, Timone Hospital, Marseille
- Patient having signed an informed consent
- Patient who is a beneficiary of or affiliated to a social security system
- Subject 18 years of age or older
Show all 9Show fewer
- 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.
- Subject who has signed an informed consent ;
- Subjects who are beneficiaries of or affiliated with a social security plan
Who cannot join
- Diagnosis of type 1 narcolepsy according to ICSD-3 criteria but without hypocretin assay
- Narcolepsy secondary to another neurological pathology or presence of a comorbid neurological pathology (multiple sclerosis, Steinert's myotonic dystrophy, head trauma, epilepsy)
- Protected patient: pregnant or breastfeeding woman, adult under guardianship or curatorship
- Contraindication 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
- Patient unable to maintain decubitus position for the duration of the MRI (= 50 minutes)
- Protected subject: pregnant or breastfeeding woman, adult under guardianship or curatorship
- 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
- Subject unable to maintain a decubitus position for the duration of the MRI (= 50 minutes)
Trial locations and contacts
1 site in 1 country.
France1 site
Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil
Marseille, 13005
About this study
Official title: Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy: Pilot Study
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.
- Conditions
- Narcolepsy Type 1
- Being tested
- 7T MRI
- Keywords
- narcolepsy, 7T MRI, hypothalamus
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T MRIOther
Patients and healthy volunteers will have a 7T MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 1 narcolepsy | Experimental | Patients with type 1 narcolepsy Receives: Other: 7T MRI |
| Healthy volunteers | Active comparator | Not described Receives: Other: 7T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothalamic morphological difference
Significant structural size difference between right and left lateral hypothalamus
Measured: Month 0
Secondary outcomes (2)
Microstructural abnormalities other than volume differences
Significant difference in Diffusion and T2* values in the lateral hypothalamus
Measured: Month 0
Structural changes in hypothalamic nuclei other than the lateral hypothalamus
Significant difference in volumes and T1 values in other regions of the posterior hypothalamus
Measured: Month 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start29 Jan 2024
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Crémieux, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967832
- Sponsor's protocol ID
- RCAPHM22_0378
- Other IDs
- ID-RCB
- Acronym
- NARCO7T
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy: Pilot Study
- ClinicalTrials.gov ID
- NCT05967832
- Acronym / sponsor ID
- NARCO7T / RCAPHM22_0378
- Conditions
- Narcolepsy Type 1
- Keywords
- narcolepsy, 7T MRI, hypothalamus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 1 narcolepsy | Experimental | Other: 7T MRIPatients with type 1 narcolepsy |
| Healthy volunteers | Active comparator | Other: 7T MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Patient at least 18 years old
- Patient followed at the Narcolepsy and Rare Hypersomnias Competence Center, Timone Hospital, Marseille
- Patient having signed an informed consent
- Patient who is a beneficiary of or affiliated to a social security system
Key exclusion criteria (8 listed)
- Diagnosis of type 1 narcolepsy according to ICSD-3 criteria but without hypocretin assay
- Narcolepsy secondary to another neurological pathology or presence of a comorbid neurological pathology (multiple sclerosis, Steinert's myotonic dystrophy, head trauma, epilepsy)
- Protected patient: pregnant or breastfeeding woman, adult under guardianship or curatorship
- Contraindication 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
- Patient unable to maintain decubitus position for the duration of the MRI (= 50 minutes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7T MRIPatients and healthy volunteers will have a 7T MRI | Other | Healthy volunteers, Patients with type 1 narcolepsy |
Primary outcome
Hypothalamic morphological difference
Time frame: Month 0
Significant structural size difference between right and left lateral hypothalamus
2 secondary outcomes
Microstructural abnormalities other than volume differences
Time frame: Month 0
Structural changes in hypothalamic nuclei other than the lateral hypothalamus
Time frame: Month 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Crémieux study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7T MRI in people with Narcolepsy Type 1, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothalamic morphological difference (time frame: Month 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.