Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06336057

Mentalizating in Adults Suffering from Narcolepsy Type 1.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Toulouse, 31059, France

Location status: Recruiting

Location contact

Rachel DEBS, MD

CONTACT

[email protected]

05 61 77 94 88

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mentalization

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Comparison and description of mentalization abilities in a population of patients versus controls.

    Time frame: During the inclusion visit

    comparison of Mental states task scale

  2. 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

    comparison of Satisfaction with life scale

  3. 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

    Time between the appearance of the first symptoms of narcolepsy and the initiation of treatment (only in the patient group)

  4. 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

    Age at the first symptoms of narcolepsy (only in the patient group)

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel DEBS, MD

CONTACT

[email protected]

05 61 77 94 88

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Mentalizating in Adults Suffering from Narcolepsy Type 1, a Comparative Prospective Study.

Acronym: NARCOMENTAL

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 28, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.