Examining mentalization in adults with narcolepsy type 1
Mentalizating in Adults Suffering from Narcolepsy Type 1, a Comparative Prospective Study.
This study is trying to see if adults with narcolepsy type 1 have trouble understanding their own and others' feelings compared to people with sleep apnea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06336057 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate potential impairments in mentalization among adults diagnosed with narcolepsy type 1 (NT1). The researchers hypothesize that individuals with NT1 may experience difficulties in understanding their own and others' mental states, which could affect their emotional regulation and daily functioning. Participants will complete validated questionnaires to assess their mentalization abilities, comparing results between the NT1 group and a control group of patients with obstructive sleep apnea. The study seeks to shed light on the emotional and cognitive challenges faced by narcoleptic patients.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with narcolepsy type 1 and those treated for obstructive sleep apnea.
Not a fit: Patients with a history of autism spectrum disorder, chronic psychotic disorders, or cognitive disorders of neurological origin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the emotional and cognitive impairments in narcolepsy type 1, leading to better patient support and management strategies.
How similar studies have performed: While studies on narcolepsy have explored various aspects of the condition, this specific focus on mentalization is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toulouse
- University Hospital Toulouse, Centre de compétence Narcolepsies et Hypersomnies rares, Hôpital Pierre-Paul Riquet — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Rachel DEBS, MD — Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet
- Study coordinator: Rachel DEBS, MD
- Email: debs.r@chu-toulouse.fr
- Phone: 05 61 77 94 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.