Status:
COMPLETED
Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Narcolepsy
Eligibility:
All Genders
6+ years
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 (cataplexi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 27 2023
Estimated Enrollment :
1605 Patients enrolled
Trial Details
Trial ID
NCT03765892
Start Date
February 27 2020
End Date
February 27 2023
Last Update
April 18 2023
Active Locations (18)
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1
Centre de médecine du Sommeil CHU d'Angers
Angers, France, 49033
2
Service d'Explorations Fonctionnelles du Système Nerveux, Clinique du Sommeil, CHU de Bordeaux Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
3
Unité de sommeil pédiatrique - Hôpital femme Mère Enfant - Hospices civils de Lyon
Bron, France, 69677
4
Service de neurophysiologie clinique CHU de Dijon
Dijon, France, 21 079