Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia (COGNAR)
Primary Purpose
Narcolepsy, Social Cognition
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionary
Sponsored by
About this trial
This is an interventional screening trial for Narcolepsy focused on measuring Narcolepsy, social cognition
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
Sites / Locations
- CHU Amiens-PicardieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
NT1
NT2
HSI
Arm Description
type 1 narcolepsy
type 2 narcolepsy
idiopathic hypersomnia
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05773872
First Posted
March 7, 2023
Last Updated
March 17, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05773872
Brief Title
Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia
Acronym
COGNAR
Official Title
Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy, Social Cognition
Keywords
Narcolepsy, social cognition
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NT1
Arm Type
Experimental
Arm Description
type 1 narcolepsy
Arm Title
NT2
Arm Type
Experimental
Arm Description
type 2 narcolepsy
Arm Title
HSI
Arm Type
Active Comparator
Arm Description
idiopathic hypersomnia
Intervention Type
Other
Intervention Name(s)
Questionary
Intervention Description
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 Measure Information:
Title
Mean SART score in the three groups
Description
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
Title
Mean IGT score in the three groups
Description
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
Title
Mean UPPS score in the three groups
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde FLAMAND, MD
Phone
0322455959
Email
Flamand.mathilde@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde FLAMAND, MD
Phone
0322455959
Email
Flamand.mathilde@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Aurélie BASILLE-FANTINATO, MD
First Name & Middle Initial & Last Name & Degree
Véronique QUAGLINO, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia
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