An observational study in Narcolepsy Type 1, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by University Hospital, Toulouse · Observational
The main objective is to examine the potential mentalization impairments affecting a population suffering from narcolepsy type 1. Indeed, the hypothesis of this research is that mentalization could be impaired in narcoleptic patients.
Narcolepsy type 1 (NT1) is a rare and still poorly understood pathology which can have a significant impact on patient's daily life. Beyond the experience of their chronic illness, their feelings about the difficulties they go through during their lives seem relatively blunted, as if what could be described as restrictive could be acceptable for them. Moreover, the response generated by constraint, even if it is a refusal, rarely turns out to be impulsive or aggressive.
Rapid Eye Movement (REM) sleep is known to play a role in emotional regulation and also in narcolepsy. These processes both take place in hypothalamus, so, a link between them seems conceivable. Surprisingly, the studies about depression, impulsivity, addictions, facial emotional recognition in narcoleptic patients show results that differs from the expectations of the investigators, and can even be at the opposite. It appears difficult to have a clear idea of the mental state of narcoleptic patients.
Mentalization is a concept with a strong empirical base. It corresponds to ability to understand the mental state, of oneself or others, that underlies overt behaviour. The idea of this research is that this process is modified in narcoleptic patients.
The main objective is to examine the potential mentalization impairments affecting a population suffering from narcolepsy type 1. To realise this study a group of patients with NT1 and a control group will complete several questionnaires which are validated about mentalization and other ones. This combination of questionnaire is designed to evaluate the comparability of the groups and search for potential confounding factors.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's planned enrollment of 60 is below the median of 135 across 38 observational studies indexed under Narcolepsy.
Browse Narcolepsy studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patients recruited are patients currently followed in the Narcolepsy and Rare Hypersomnia Competence Center at Toulouse University Hospital, with a diagnosis of NT1.
The witnesses are people followed in the sleep unit of the Toulouse University Hospital in the context of treated OSA.
All participants will be contacted by telephone or during a follow-up consultation to ask them to participate in this study. An information sheet will be provided to them by mail or in person.
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.
For the NT1 patient group:
For the control group:
Exclusion Criteria:
Group of patients with narcolepsy type 1.
Behavioral: Mentalization
Group of control patients with Obstructive Sleep Apnea (OSA) corrected by treatments
Behavioral: Mentalization
complete several questionnaires including the RFQ (reflective functioning questionnaire) and the MST (Mental states task) which are validated questionnaires about mentalization
Comparison of mentalization abilities, in a population of patients with NT1 versus a control group.
Scores obtained for the two sub-dimensions of the Reflective functioning questionnaire (RFQ) scale: RFQc and RFQu
Time frame: During the inclusion visit
Comparison and description of mentalization abilities in a population of patients versus controls.
comparison of Mental states task scale
Time frame: During the inclusion visit
Better characterization of the clinical impression of an altered subjective experience of the difficulties the patients are going through.
comparison of Satisfaction with life scale
Time frame: During the inclusion visit
Determination of the existence of a correlation between the time of appearance of the first symptoms and the initiation of treatment and the level of mentalization in NT1 patients, or not.
Time between the appearance of the first symptoms of narcolepsy and the initiation of treatment (only in the patient group)
Time frame: During the inclusion visit
Determination of the existence of a correlation between the age at the first symptoms of NT1 patients and mentalization abilities, or not.
Age at the first symptoms of narcolepsy (only in the patient group)
Time frame: During the inclusion visit
Plan to share: No
Ran from May 2024 to primary completion in May 2024, 0 months.
Of 19 observational studies under Narcolepsy, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 73. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet 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, Toulouse →