- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05773872
Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia (COGNAR)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mathilde FLAMAND, MD
- Phone Number: 0322455959
- Email: Flamand.mathilde@chu-amiens.fr
Study Locations
-
-
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Amiens, France, 80054
- Recruiting
- CHU Amiens-Picardie
-
Contact:
- Mathilde FLAMAND, MD
- Phone Number: 0322455959
- Email: Flamand.mathilde@chu-amiens.fr
-
Sub-Investigator:
- Aurélie BASILLE-FANTINATO, MD
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Sub-Investigator:
- Véronique QUAGLINO, Pr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NT1
type 1 narcolepsy
|
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
|
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
|
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) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean SART score in the three groups
Time Frame: 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 years
|
Mean IGT score in the three groups
Time Frame: 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.
|
2 years
|
Mean UPPS score in the three groups
Time Frame: 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.
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2022_843_0022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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