Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionary.
- Who it may be relevant to
- Registry conditions: Narcolepsy, Social Cognition. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Narcolepsy is a chronic disabling neurologic disorder mainly characterised by excessive daytime sleepiness. Type 1 narcolepsy is associated with a deficit of hypocretin in the cerebrospinal fluid responsible for the cataplexy symptom while type 2 shows a normal hypocretin level and no cataplexy. While the development of narcolepsy is independent of parental social level, narcolepsy has a significant influence on educational level, grading, social outcome, and welfare consequences. Several studies assessed global cognition efficiency, mood, and attention in narcoleptic patients but only a few specifically measured social cognition and mostly without a control group. In a population of narcoleptics children, a severe impairment in social cognition is described for 20% of the group, contrary to 2 % for the control group. The literature also depicts some impairments in decision making, somatic and cognitive emotions responses but the emotion recognition seems to be preserved. A better understanding of the social and cognitive aspects of narcolepsy could lead to a better treatment of the disease in its entirety, including if relevant specific cognitive behavioural therapy. The protocol consists in a psychometric evaluation including several questionnaires in order to assess social cognition. It will be proposed to patients with type 1 or type 2 narcolepsy and patients with idiopathic hypersomnia.
Interventions
- Other Questionary
In addition to the usual care, the patient will complete the following validated questionnaires : SART (Sustained Attention to Response Task), IGT (Iowa Gambling Task), UPPS (Impulsive Behaviour Scale), TAS (Toronto Alexithymia Scale), BES (Basic Empathy Scale), FRET (Facial Emotions Recognition Task), ERF-CS, MASC (Movie for the Assessment of Social Cognition)
Primary outcome measures
- Mean SART score in the three groups [Time frame: 2 years]
- Mean IGT score in the three groups [Time frame: 2 years]
- Mean UPPS score in the three groups [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- adult patients (>/= 18years old)
- diagnosis of type 1 or type 2 narcolepsy or idiopathic hypersomnia
- non opposition
Exclusion criteria
- comorbid psychiatric or neurologic disease
- patient under 18 years old
- patient under guardianship, curators or deprived of liberty, refusal of the patient
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Screening
Study locations
France · 1 center
- CHU Amiens-Picardie — Amiens
Identifiers
NCT: NCT05773872 · PI2022_843_0022