Mentalizating in Adults Suffering from Narcolepsy Type 1.
ConditionNarcolepsy Type 1
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient having been diagnosed with type 1 narcolepsy according to ICSD 3 criteria and the completion of a 48-hour polysomnography at the Sleep Laboratory
Patient affiliated to or beneficiary of a social security system
Patient over 18 years old
Patient followed at Toulouse University Hospital and treated for Obstructive sleep apnea (OSA) with a residual AHI <5/h, demonstrating the absence of residual OSA under treatment
Disqualifiers
Patient with a history of autism spectrum disorder, chronic psychotic disorder, or bipolar disorder.
Patient with a history of cognitive disorders of neurological origin
Patient with a linguistic level in French that does not allow sufficient understanding to complete the questionnaires
Patient under legal protection measure, under guardianship or curatorship
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Mentalization
Behavioralcomplete several questionnaires including the RFQ (reflective functioning questionnaire) and the MST (Mental states task) which are validated questionnaires about mentalization
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Patients1 intervention
Group B: Controls1 intervention
Trial outcomes
Primary outcomes
1
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 visitSecondary outcomes
1
Comparison and description of mentalization abilities in a population of patients versus controls.
comparison of Mental states task scale
Time frame
During the inclusion visit2
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 visit3
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 visit4
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 visitSponsors and contacts
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Source ClinicalTrials.gov