Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult patients (>/= 18years old)

diagnosis of type 1 or type 2 narcolepsy or idiopathic hypersomnia

non opposition

Disqualifiers

comorbid psychiatric or neurologic disease

patient under 18 years old

patient under guardianship, curators or deprived of liberty, refusal of the patient

Trial design

Design model

Parallel

Treatments tested in this trial

  • Questionary

    Other intervention

    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)

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: NT1Experimental treatment 1 intervention
Group B: NT2Experimental treatment 1 intervention
Group C: HSIActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean SART score in the three groups

SART is Sustained Attention to Response Task. The Sustained Attention to Response Task (SART) is a computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target (often the digit 3) presented amongst a background of frequent non-targets (0-2, 4-9). There is evidence supporting the role of the SART as a measure of working memory, sustained attention, and impulse/inhibitory control.

Time frame
2 years
2

Mean IGT score in the three groups

The Iowa gambling task (IGT) is a psychological task thought to simulate real-life decision making. Participants are presented with four virtual decks of cards on a computer screen. They are told that each deck holds cards that will either reward or penalize them, using game money. The goal of the game is to win as much money as possible. Net scores are calculated as follow: \[advantageous decks (C + D) minus disadvantageous decks (A + B)\] for five blocks of 20 selections.

Time frame
2 years
3

Mean UPPS score in the three groups

UPPS (Impulsive Behaviour Scale). The Impulsive behavior scale (S-UPPS-P) is an instrument composed of 20 items rated on a four-point Likert scale (23): (1) disagree strongly, (2) disagree some, (3) agree some, and (4) agree strongly. Scores are presented for each of five subscales, plus a total impulsivity score. In addition to the raw scores, in order to put each subscale into the same metric, the mean is calculated for the items on each subscale, from 1 to 4, where 1 indicates that the respondent did not indorse impulsive answers, and 4 indicating a high level of self-reported impulsivity.

Time frame
2 years

Secondary outcomes

Other outcomes

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