Mentalizating in Adults Suffering from Narcolepsy Type 1.
NCT ID: NCT06336057
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2024-05-17
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients
Group of patients with narcolepsy type 1.
Mentalization
complete several questionnaires including the RFQ (reflective functioning questionnaire) and the MST (Mental states task) which are validated questionnaires about mentalization
Controls
Group of control patients with Obstructive Sleep Apnea (OSA) corrected by treatments
Mentalization
complete several questionnaires including the RFQ (reflective functioning questionnaire) and the MST (Mental states task) which are validated questionnaires about mentalization
Interventions
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Mentalization
complete several questionnaires including the RFQ (reflective functioning questionnaire) and the MST (Mental states task) which are validated questionnaires about mentalization
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Rachel DEBS, MD
Role: PRINCIPAL_INVESTIGATOR
Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet
Locations
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University Hospital Toulouse, Centre de compétence Narcolepsies et Hypersomnies rares, Hôpital Pierre-Paul Riquet
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Dauvilliers, Yves. " PNDS narcolepsie type 1 et 2 ". HAS, s. d.
Other Identifiers
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RC31/23/0408
Identifier Type: -
Identifier Source: org_study_id
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