Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)

Narcolepsy is a chronic, disabling, and rare sleep disorder (prevalence 1/2500) characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults. Symptoms of narcolepsy are responsible for an important handicap in everyday life, and are often misunderstood by the family and professional environment. In addition, many comorbidities are associated with narcolepsy, such as depression, anxiety, or obesity.

Few studies have investigated the impact of narcolepsy on patients' academic background, socio-professional integration, and quality of life.

Narcoleptic patients may experience more difficulties in their academic and professional path than non-narcoleptic people. These difficulties would be multifactorial (related to the disease itself, comorbidities, external factors ...).

As a better understanding of these determinants could help to inform patients and guide them in their choices, this study propose to establish a comprehensive inventory of educational and professional trajectories of narcoleptic patients in France in order assess the specificity of the difficulties encountered by the people concerned in their life course and to appreciate the attitude of the academic and professional circle with respect to the disease.

This category 3 study (according to the French law "Loi Jardé") is based on the case-control model and will be conducted in all National Reference and Competence Centers for Narcolepsy and Hypersomnia. It will include a population of adult and paediatric patients. It will answer questions about work and schooling in these patients.

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Key information

Conditions

Narcolepsy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de médecine du Sommeil CHU d'Angers, Angers, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The case group:

Children (6 years <age <18 years) or adults with type 1 narcolepsy diagnosed on:
a clinic in favor of narcolepsy: excessive daytime sleepiness lasting for more than 3 months.
cataplexy and an positive multiple sleep latency test (mean sleep latency ≤ 8 min and ≥ 2 SOREM) or a hypocretin dosage in the CSF <110pg / L.
Patients followed in one of the centers participating in the research.

The control group:

At least one person close to the case (cousins, close friends ...).
For adults: same sex as the case and if possible same age (+/- 5 years).
For minors: same sex and if possible same age (+/- 2 years).
Person not suffering from narcolepsy.

Exclusion criteria

The case group:

Patients refusing to participate.
Patients who do not speak the French language (incompatible with the reading, the comprehension and the filling of the questionnaires).
Patients whose diagnosis of type 1 narcolepsy is not certain and / or has type 2 narcolepsy.
Patients with narcolepsy symptomatic of another neurological disease.

The group controls:

Person refusing to participate.
Person who does not speak French (incompatible with reading, understanding and filling out questionnaires).
The brothers and sisters of the case cannot be witnesses of the study.

Treatment and study plan

Questionnaire (Adult)

Other

Patients and case control will have to respond to the study questionnaire on the online entry platform to compare the distribution of socio-professional categories.

Answering the questionnaires will take 45 minutes.

Questionnaire (Children)

Other

Patients and case control will have to respond to the study questionnaire on the online entry platform to compare the proportion of subjects having repeated grades.

Answering the questionnaires will take 45 minutes.

Primary outcomes

For adult : distribution of professional situations

Time frame: 45 minutes (time to answering the questionnaire)

Distribution of professional situations in narcoleptic adult patients and related non-narcoleptic topics (employed, unemployed, student, retired, housewife/husband). (data collection form "professional situation").
For children : proportion of children who repeated a grade

Time frame: 45 minutes (time to answering the questionnaire)

Proportion of children who repeated a grade in narcoleptic children and non-narcoleptic control children ("school status" data collection form).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Dec 5, 2018
Registry last updated: Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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