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

Narcolepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765892
• Other study ID #: 69HCL18_0314
• Status: Completed
• Start date: February 27, 2020
• Est. completion date: February 27, 2023

Study information

• Verified date: April 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1605
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Narcolepsy

Intervention

Other:
• Questionnaire (Adult)
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)
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.

Locations

Country	Name	City	State
France	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	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 physiologie et Exploration fonctionnelle - Unité du Sommeil Hôpital Raymond Poincarré	Garches
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 neurophysiologie clinique - centre du sommeil - Hôpital de la Timone	Marseille
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	Centre pédiatrique des pathologies du sommeil APHP CHU Robert Debré - Paris	Paris
France	Service de Physiologie Explorations fonctionnelles Hôpital Bichat Claude Bernard	Paris
France	Service des pathologies du sommeil Hôpital Pitié-Salpêtrière	Paris
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	Explorations Neurophysiologiques, Hôpital Pierre Paul Riquet, CHU Toulouse Purpan	Toulouse
France	Centre du Sommeil du Service de Neurologie et de Neurophysiologie Clinique - CHRU Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For adult : distribution of professional situations	Distribution of professional situations in narcoleptic adult patients and related non-narcoleptic topics (employed, unemployed, student, retired, housewife/husband). (data collection form "professional situation").	45 minutes (time to answering the questionnaire)
Primary	For children : proportion of children who repeated a grade	Proportion of children who repeated a grade in narcoleptic children and non-narcoleptic control children ("school status" data collection form).	45 minutes (time to answering the questionnaire)