Mentalizating in Adults Suffering from Narcolepsy Type 1.

NCT06336057 | Recruiting

• 1 other identifier: RC31/23/0408
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Narcolepsy Type 1

Keywords

Narcolepsy type 1; Mentalization; Reflective functioning questionnaire; Mental states task

Outcome Measures

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

  During the inclusion visit

Secondary Outcomes (4)

• 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

Study Arms (2)

Patients

Group of patients with narcolepsy type 1.

Behavioral: Mentalization

Controls

Group of control patients with Obstructive Sleep Apnea (OSA) corrected by treatments

Behavioral: Mentalization

Interventions

Mentalization BEHAVIORAL

complete several questionnaires including the RFQ (reflective functioning questionnaire) and the MST (Mental states task) which are validated questionnaires about mentalization

Controls; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse, Centre de compétence Narcolepsies et Hypersomnies rares, Hôpital Pierre-Paul Riquet

Toulouse, 31059, France

RECRUITING

Related Publications (11)

• 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.

  PMID: 26564129 BACKGROUND

• 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.

  PMID: 28940143 BACKGROUND

• 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.

  PMID: 21203380 BACKGROUND

• 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.

  PMID: 23280811 BACKGROUND

• 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.

  PMID: 27392018 BACKGROUND

• 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.

  PMID: 32671534 BACKGROUND

• 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.

  PMID: 32023093 BACKGROUND

• 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.

  PMID: 34597256 BACKGROUND

• 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.

  PMID: 28675858 BACKGROUND

• 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.

  PMID: 28363681 BACKGROUND

• 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.

  PMID: 32496883 BACKGROUND

Related Links

• Dauvilliers, Yves. " PNDS narcolepsie type 1 et 2 ". HAS, s. d.

MeSH Terms

Interventions

Mentalization-Based Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rachel DEBS, MD

  Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel DEBS, MD

CONTACT

05 61 77 94 88; debs.r@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: May 17, 2024
• Primary Completion: May 17, 2024
• Study Completion: December 1, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)