Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)
- Conditions
- Narcolepsy
- Interventions
- Other: Questionnaire (Children)Other: Questionnaire (Adult)
- Registration Number
- NCT03765892
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1605
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children Control Group Questionnaire (Children) Close friends and cousins of included narcoleptic children, minor and not suffering from narcolepsy. Adult Case Group Questionnaire (Adult) Adults with type 1 narcolepsy according to the ICSD3 Adult Control Group Questionnaire (Adult) Parents, cousins and / or friends of included narcoleptic adult patients, at least 18 years old and not suffering from narcolepsy. Children Case Group Questionnaire (Children) Children with type 1 narcolepsy according to the OCSD3
- Primary Outcome Measures
Name Time Method For children : proportion of children who repeated a grade 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).
For adult : distribution of professional situations 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").
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Centre de médecine du Sommeil CHU d'Angers
🇫🇷Angers, France
Service d'Explorations Fonctionnelles du Système Nerveux, Clinique du Sommeil, CHU de Bordeaux Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Service de physiologie et Exploration fonctionnelle - Unité du Sommeil Hôpital Raymond Poincarré
🇫🇷Garches, France
Unité de sommeil pédiatrique - Hôpital femme Mère Enfant - Hospices civils de Lyon
🇫🇷Bron, France
Service de neurophysiologie clinique CHU de Dijon
🇫🇷Dijon, France
Service de Neurophysiologie Clinique, Hôpital Roger Salengro
🇫🇷Lille, France
Centre de Médecine du Sommeil et des Maladies respiratoires - Centre Hospitalier de la Croix Rousse - Hospices Civils de Lyon
🇫🇷Lyon, France
Service de Neurologie - Troubles du Sommeil Hôpital Gui de Chauliac
🇫🇷Montpellier, France
Laboratoire d'Explorations Fonctionnelles Neurologiques, CHU de Nantes
🇫🇷Nantes, France
Centre du Sommeil et de la vigilance - Centre de référence Hypersomnies rares - Hôpital de l'Hôtel Dieu
🇫🇷Paris, France
Service de Physiologie Explorations fonctionnelles Hôpital Bichat Claude Bernard
🇫🇷Paris, France
Service des pathologies du sommeil Hôpital Pitié-Salpêtrière
🇫🇷Paris, France
Explorations Neurophysiologiques, Hôpital Pierre Paul Riquet, CHU Toulouse Purpan
🇫🇷Toulouse, France
Service de Neurophysiologie Clinique et Centre du Sommeil, CHU de Poitiers
🇫🇷Poitiers, France
Centre des Troubles du Sommeil, Hospices Civils de Strasbourg
🇫🇷Strasbourg, France
Centre du Sommeil du Service de Neurologie et de Neurophysiologie Clinique - CHRU Bretonneau
🇫🇷Tours, France
Service de neurophysiologie clinique - centre du sommeil - Hôpital de la Timone
🇫🇷Marseille, France
Centre pédiatrique des pathologies du sommeil APHP CHU Robert Debré - Paris
🇫🇷Paris, France