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

C

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

Social Cognition
Narcolepsy

Treatments

Other: Questionary

Study type

Interventional

Funder types

Other

Identifiers

NCT05773872
PI2022_843_0022

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

75 participants in 3 patient groups

NT1
Experimental group
Description:
type 1 narcolepsy
Treatment:
Other: Questionary
NT2
Experimental group
Description:
type 2 narcolepsy
Treatment:
Other: Questionary
HSI
Active Comparator group
Description:
idiopathic hypersomnia
Treatment:
Other: Questionary

Trial contacts and locations

1

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Central trial contact

Mathilde FLAMAND, MD

Data sourced from clinicaltrials.gov

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