Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-01 @ 6:59 PM
Study NCT ID:
NCT06336057
Status:
RECRUITING
Last Update Posted:
2024-09-25
First Post:
2024-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mentalizating in Adults Suffering from Narcolepsy Type 1.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088042', 'term': 'Mentalization-Based Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of mentalization abilities, in a population of patients with NT1 versus a control group.', 'timeFrame': 'During the inclusion visit', 'description': 'Scores obtained for the two sub-dimensions of the Reflective functioning questionnaire (RFQ) scale: RFQc and RFQu'}], 'secondaryOutcomes': [{'measure': 'Comparison and description of mentalization abilities in a population of patients versus controls.', 'timeFrame': 'During the inclusion visit', 'description': 'comparison of Mental states task scale'}, {'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', 'description': 'comparison of Satisfaction with life scale'}, {'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', 'description': 'Time between the appearance of the first symptoms of narcolepsy and the initiation of treatment (only in the patient group)'}, {'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', 'description': 'Age at the first symptoms of narcolepsy (only in the patient group)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Narcolepsy type 1', 'Mentalization', 'Reflective functioning questionnaire', 'Mental states task'], 'conditions': ['Narcolepsy Type 1']}, 'referencesModule': {'references': [{'pmid': '26564129', 'type': 'BACKGROUND', '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.'}, {'pmid': '28940143', 'type': 'BACKGROUND', '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.'}, {'pmid': '21203380', 'type': 'BACKGROUND', '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.'}, {'pmid': '23280811', 'type': 'BACKGROUND', '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.'}, {'pmid': '27392018', 'type': 'BACKGROUND', '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.'}, {'pmid': '32671534', 'type': 'BACKGROUND', '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.'}, {'pmid': '32023093', 'type': 'BACKGROUND', '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.'}, {'pmid': '34597256', 'type': 'BACKGROUND', '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.'}, {'pmid': '28675858', 'type': 'BACKGROUND', '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.'}, {'pmid': '28363681', 'type': 'BACKGROUND', '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.'}, {'pmid': '32496883', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'https://www.has-sante.fr/upload/docs/application/pdf/2021-10/texte_pnds_narcolepsies_annexes.pdf', 'label': 'Dauvilliers, Yves. " PNDS narcolepsie type 1 et 2 ". HAS, s. d.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nRapid 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.\n\nMentalization 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients recruited are patients currently followed in the Narcolepsy and Rare Hypersomnia Competence Center at Toulouse University Hospital, with a diagnosis of NT1.\n\nThe witnesses are people followed in the sleep unit of the Toulouse University Hospital in the context of treated OSA.\n\nAll 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor the NT1 patient group:\n\n* 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\n* Patient affiliated to or beneficiary of a social security system\n\nFor the control group:\n\n* Patient over 18 years old\n* 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\n* Patient affiliated to or beneficiary of a social security system\n\nExclusion Criteria:\n\n* Patient with a history of autism spectrum disorder, chronic psychotic disorder, or bipolar disorder.\n* Patient with a history of cognitive disorders of neurological origin\n* Patient with a linguistic level in French that does not allow sufficient understanding to complete the questionnaires\n* Patient under legal protection measure, under guardianship or curatorship\n* Pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT06336057', 'acronym': 'NARCOMENTAL', 'briefTitle': 'Mentalizating in Adults Suffering from Narcolepsy Type 1.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Mentalizating in Adults Suffering from Narcolepsy Type 1, a Comparative Prospective Study.', 'orgStudyIdInfo': {'id': 'RC31/23/0408'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Group of patients with narcolepsy type 1.', 'interventionNames': ['Behavioral: Mentalization']}, {'label': 'Controls', 'description': 'Group of control patients with Obstructive Sleep Apnea (OSA) corrected by treatments', 'interventionNames': ['Behavioral: Mentalization']}], 'interventions': [{'name': 'Mentalization', 'type': 'BEHAVIORAL', 'description': 'complete several questionnaires including the RFQ (reflective functioning questionnaire) and the MST (Mental states task) which are validated questionnaires about mentalization', 'armGroupLabels': ['Controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rachel DEBS, MD', 'role': 'CONTACT', 'email': 'debs.r@chu-toulouse.fr', 'phone': '05 61 77 94 88'}], 'facility': 'University Hospital Toulouse, Centre de compétence Narcolepsies et Hypersomnies rares, Hôpital Pierre-Paul Riquet', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Rachel DEBS, MD', 'role': 'CONTACT', 'email': 'debs.r@chu-toulouse.fr', 'phone': '05 61 77 94 88'}], 'overallOfficials': [{'name': 'Rachel DEBS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}