Mentalizating in Adults Suffering From Narcolepsy Type 1, a Comparative Prospective Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Comparison of mentalization abilities, in a population of patients with NT1 versus a control group.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •For the NT1 patient group:
- •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
- •For the control group:
- •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
- •Patient affiliated to or beneficiary of a social security system
Exclusion Criteria
- •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
- •Pregnant or breastfeeding woman
Outcomes
Primary Outcomes
Comparison of mentalization abilities, in a population of patients with NT1 versus a control group.
Time Frame: During the inclusion visit
Scores obtained for the two sub-dimensions of the Reflective functioning questionnaire (RFQ) scale: RFQc and RFQu
Secondary Outcomes
- Comparison and description of mentalization abilities in a population of patients versus controls.(During the inclusion visit)
- Better characterization of the clinical impression of an altered subjective experience of the difficulties the patients are going through.(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.(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.(During the inclusion visit)