Narcolepsy Type 1NARCOMENTALNCT06336057
Mentalizating in Adults Suffering from Narcolepsy Type 1.
An observational study of Narcolepsy Type 1, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy Type 1
- What is being tested?
- Mentalization
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse, Centre de compétence Narcolepsies et Hypersomnies rares, Hôpital Pierre-Paul Riquet
Toulouse, 31059
Rachel DEBS, MD, 05 61 77 94 88, debs.r@chu-toulouse.fr
About this study
Official title: Mentalizating in Adults Suffering from Narcolepsy Type 1, a Comparative Prospective Study.
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.
Read the 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.
- Conditions
- Narcolepsy Type 1
- Being tested
- Mentalization
- Keywords
- Narcolepsy type 1, Mentalization, Reflective functioning questionnaire, Mental states task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentalizationBehavioural
complete several questionnaires including the RFQ (reflective functioning questionnaire) and the MST (Mental states task) which are validated questionnaires about mentalization
| Study group | Role | What they receive |
|---|---|---|
| Patients | Group of patients with narcolepsy type 1. Receives: Behavioral: Mentalization | |
| Controls | Group of control patients with Obstructive Sleep Apnea (OSA) corrected by treatments Receives: Behavioral: Mentalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the inclusion visit
Secondary outcomes (4)
Comparison and description of mentalization abilities in a population of patients versus controls.
comparison of Mental states task scale
Measured: During the inclusion visit
Better characterization of the clinical impression of an altered subjective experience of the difficulties the patients are going through.
comparison of Satisfaction with life scale
Measured: 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.
Time between the appearance of the first symptoms of narcolepsy and the initiation of treatment (only in the patient group)
Measured: 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.
Age at the first symptoms of narcolepsy (only in the patient group)
Measured: During the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start17 May 2024
- Primary completion17 May 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel DEBS, MD, Principal investigator, Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336057
- Sponsor's protocol ID
- RC31/23/0408
- Acronym
- NARCOMENTAL
- Status last verified
- Sep 2024
- First submitted
- 21 Mar 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26564129Barateau 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.
PubMed 28940143Bayard 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.
PubMed 21203380Beaulieu-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.
PubMed 23280811Fonagy 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.
PubMed 27392018Li 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.
PubMed 32671534Luyten 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.
PubMed 32023093Muller 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.
PubMed 34597256Perroud 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.
PubMed 28675858Pessoa 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.
PubMed 28363681Tohme 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.
PubMed 32496883
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentalizating in Adults Suffering from Narcolepsy Type 1, a Comparative Prospective Study.
- ClinicalTrials.gov ID
- NCT06336057
- Acronym / sponsor ID
- NARCOMENTAL / RC31/23/0408
- Conditions
- Narcolepsy Type 1
- Keywords
- Narcolepsy type 1, Mentalization, Reflective functioning questionnaire, Mental states task
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: MentalizationGroup of patients with narcolepsy type 1. |
| Controls | – | Behavioral: MentalizationGroup of control patients with Obstructive Sleep Apnea (OSA) corrected by treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalizationcomplete several questionnaires including the RFQ (reflective functioning questionnaire) and the MST (Mental states task) which are validated questionnaires about mentalization | Behavioural | Controls, Patients |
Primary outcome
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
4 secondary outcomes
Comparison and description of mentalization abilities in a population of patients versus controls.
Time frame: During the inclusion visit
Better characterization of the clinical impression of an altered subjective experience of the difficulties the patients are going through.
Time frame: 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.
Time frame: 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.
Time frame: During the inclusion visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 26564129Barateau 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.
- Background: PubMed 28940143Barateau 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.
- Background: PubMed 21203380Bayard 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.
- Background: PubMed 23280811Beaulieu-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.
- Background: PubMed 27392018Fonagy 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.
- Background: PubMed 32671534Li 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.
- Background: PubMed 32023093Luyten 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.
- Background: PubMed 34597256Muller 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.
- Background: PubMed 28675858Perroud 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.
- Background: PubMed 28363681Pessoa 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.
- Background: PubMed 32496883Tohme 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.
- Dauvilliers, Yves. " PNDS narcolepsie type 1 et 2 ". HAS, s. d.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel DEBS, MD principal investigator
Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy Type 1, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel DEBS, MD (05 61 77 94 88, debs.r@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of mentalization abilities, in a population of patients with NT1 versus a control group. (time frame: During the inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06336057, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.