Clinical trial NCT06336057: Mentalizating in Adults Suffering from Narcolepsy Type 1.
Official title: Mentalizating in Adults Suffering from Narcolepsy Type 1, a Comparative Prospective Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Narcolepsy Type 1
Keywords: Narcolepsy type 1
Mentalization
Reflective functioning questionnaire
Mental states task
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of mentalization abilities, in a population of patients with NT1 versus a control group.
timeFrame: During the inclusion visit
Secondary outcomes:
measure: Comparison and description of mentalization abilities in a population of patients versus controls.
timeFrame: During the inclusion visit
measure: Better characterization of the clinical impression of an altered subjective experience of the difficulties the patients are going through.
timeFrame: During the inclusion visit
measure: 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.
timeFrame: During the inclusion visit
measure: Determination of the existence of a correlation between the age at the first symptoms of NT1 patients and mentalization abilities, or not.
timeFrame: During the inclusion visit
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse, Centre de compétence Narcolepsies et Hypersomnies rares, Hôpital Pierre-Paul Riquet
Study officials:
affiliation: Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet
name: Rachel DEBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barateau L, Jaussent I, Lopez R, Boutrel B, Leu-Semenescu S, Arnulf I, Dauvilliers Y. Smoking, Alcohol, Drug Use, Abuse and Dependence in Narcolepsy and Idiopathic Hypersomnia: A Case-Control Study. Sleep. 2016 Mar 1;39(3):573-80. doi: 10.5665/sleep.5530.
citation: Barateau L, Liblau R, Peyron C, Dauvilliers Y. Narcolepsy Type 1 as an Autoimmune Disorder: Evidence, and Implications for Pharmacological Treatment. CNS Drugs. 2017 Oct;31(10):821-834. doi: 10.1007/s40263-017-0464-6.
citation: Bayard S, Abril B, Yu H, Scholz S, Carlander B, Dauvilliers Y. Decision making in narcolepsy with cataplexy. Sleep. 2011 Jan 1;34(1):99-104. doi: 10.1093/sleep/34.1.99.
citation: Beaulieu-Pelletier G, Bouchard MA, Philippe FL. Mental States Task (MST): development, validation, and correlates of a self-report measure of mentalization. J Clin Psychol. 2013 Jul;69(7):671-95. doi: 10.1002/jclp.21942. Epub 2012 Dec 20.
citation: Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
citation: Li X, Sanford LD, Zong Q, Zhang Y, Tan L, Li T, Ren R, Zhou J, Han F, Tang X. Prevalence of Depression or Depressive Symptoms in Patients with Narcolepsy: a Systematic Review and Meta-Analysis. Neuropsychol Rev. 2021 Mar;31(1):89-102. doi: 10.1007/s11065-020-09443-7. Epub 2020 Jul 15.
citation: Luyten P, Campbell C, Allison E, Fonagy P. The Mentalizing Approach to Psychopathology: State of the Art and Future Directions. Annu Rev Clin Psychol. 2020 May 7;16:297-325. doi: 10.1146/annurev-clinpsy-071919-015355. Epub 2020 Feb 5.
citation: Muller S, Wendt LP, Spitzer C, Masuhr O, Back SN, Zimmermann J. A Critical Evaluation of the Reflective Functioning Questionnaire (RFQ). J Pers Assess. 2022 Sep-Oct;104(5):613-627. doi: 10.1080/00223891.2021.1981346. Epub 2021 Oct 1.
citation: Perroud N, Badoud D, Weibel S, Nicastro R, Hasler R, Kung AL, Luyten P, Fonagy P, Dayer A, Aubry JM, Prada P, Debbane M. Mentalization in adults with attention deficit hyperactivity disorder: Comparison with controls and patients with borderline personality disorder. Psychiatry Res. 2017 Oct;256:334-341. doi: 10.1016/j.psychres.2017.06.087. Epub 2017 Jun 30.
citation: Pessoa L. A Network Model of the Emotional Brain. Trends Cogn Sci. 2017 May;21(5):357-371. doi: 10.1016/j.tics.2017.03.002. Epub 2017 Mar 28.
citation: Tohme P, Grey I, Abi-Habib R. The Mental States Task (MST): Correlates and New Perspectives on Mentalizing in a Lebanese Student Sample. J Pers Assess. 2021 Jul-Aug;103(4):498-508. doi: 10.1080/00223891.2020.1769114. Epub 2020 Jun 4.