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

NCT ID: NCT05773872

Last Updated: 2023-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-07

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Narcolepsy Social Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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NT1

type 1 narcolepsy

Group Type EXPERIMENTAL

Questionary

Intervention Type OTHER

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)

NT2

type 2 narcolepsy

Group Type EXPERIMENTAL

Questionary

Intervention Type OTHER

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)

HSI

idiopathic hypersomnia

Group Type ACTIVE_COMPARATOR

Questionary

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens-Picardie

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mathilde FLAMAND, MD

Role: CONTACT

0322455959

Facility Contacts

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Mathilde FLAMAND, MD

Role: primary

0322455959

Other Identifiers

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PI2022_843_0022

Identifier Type: -

Identifier Source: org_study_id

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