Clinical trial NCT03765892: Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)
Official title: Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narcolepsy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 1605
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will focus on pediatric and adult patients with type 1 narcolepsy and followed up in one of the participating rare disease reference or competence centers.

Two control banks will be constituted:

1. an "adult control" bank whose age is greater than 18 years: may be composed of the parents of included narcoleptic children or cousins and friends of included adult narcoleptic patients
2. a bank " child control' whose age is less than 18 years: may be composed of friends and cousins of included narcoleptic children.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: For adult : distribution of professional situations
timeFrame: 45 minutes (time to answering the questionnaire)
measure: For children : proportion of children who repeated a grade
timeFrame: 45 minutes (time to answering the questionnaire)
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre de médecine du Sommeil CHU d'Angers
city: Bordeaux
country: France
facility: Service d'Explorations Fonctionnelles du Système Nerveux, Clinique du Sommeil, CHU de Bordeaux Groupe Hospitalier Pellegrin
city: Bron
country: France
facility: Unité de sommeil pédiatrique - Hôpital femme Mère Enfant - Hospices civils de Lyon
city: Dijon
country: France
facility: Service de neurophysiologie clinique CHU de Dijon
city: Garches
country: France
facility: Service de physiologie et Exploration fonctionnelle - Unité du Sommeil Hôpital Raymond Poincarré
city: Lille
country: France
facility: Service de Neurophysiologie Clinique, Hôpital Roger Salengro
city: Lyon
country: France
facility: Centre de Médecine du Sommeil et des Maladies respiratoires - Centre Hospitalier de la Croix Rousse - Hospices Civils de Lyon
city: Marseille
country: France
facility: Service de neurophysiologie clinique - centre du sommeil - Hôpital de la Timone
city: Montpellier
country: France
facility: Service de Neurologie - Troubles du Sommeil Hôpital Gui de Chauliac
city: Nantes
country: France
facility: Laboratoire d'Explorations Fonctionnelles Neurologiques, CHU de Nantes
city: Paris
country: France
facility: Centre du Sommeil et de la vigilance - Centre de référence Hypersomnies rares - Hôpital de l'Hôtel Dieu
city: Paris
country: France
facility: Service de Physiologie Explorations fonctionnelles Hôpital Bichat Claude Bernard
city: Paris
country: France
facility: Service des pathologies du sommeil Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Centre pédiatrique des pathologies du sommeil APHP CHU Robert Debré - Paris
city: Poitiers
country: France
facility: Service de Neurophysiologie Clinique et Centre du Sommeil, CHU de Poitiers
city: Strasbourg
country: France
facility: Centre des Troubles du Sommeil, Hospices Civils de Strasbourg
city: Toulouse
country: France
facility: Explorations Neurophysiologiques, Hôpital Pierre Paul Riquet, CHU Toulouse Purpan
city: Tours
country: France
facility: Centre du Sommeil du Service de Neurologie et de Neurophysiologie Clinique - CHRU Bretonneau
Study officials:
References: