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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05773872
Collaborator
(none)
75
1
3
23.8
3.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionary
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Screening
Official Title:
Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia
Actual Study Start Date :
Mar 7, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: NT1

type 1 narcolepsy

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)

Experimental: NT2

type 2 narcolepsy

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)

Active Comparator: HSI

idiopathic hypersomnia

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)

Outcome Measures

Primary Outcome Measures

  1. Mean SART score in the three groups [2 years]

    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.

  2. Mean IGT score in the three groups [2 years]

    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.

  3. Mean UPPS score in the three groups [2 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens-Picardie Amiens France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT05773872
Other Study ID Numbers:
  • PI2022_843_0022
First Posted:
Mar 17, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2023