- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03765892
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Laure PETER-DEREX, MD, PhD
- Phone Number: +33 04 72 07 17 69
- Email: laure.peter-derex@chu-lyon.fr
Study Locations
-
-
-
Angers, France, 49033
- Centre de médecine du Sommeil CHU d'Angers
-
Bordeaux, France, 33076
- Service d'Explorations Fonctionnelles du Système Nerveux, Clinique du Sommeil, CHU de Bordeaux Groupe Hospitalier Pellegrin
-
Bron, France, 69677
- Unité de sommeil pédiatrique - Hôpital femme Mère Enfant - Hospices civils de Lyon
-
Dijon, France, 21 079
- Service de neurophysiologie clinique CHU de Dijon
-
Garches, France, 92 380
- Service de physiologie et Exploration fonctionnelle - Unité du Sommeil Hôpital Raymond Poincarré
-
Lille, France, 59037
- Service de Neurophysiologie Clinique, Hôpital Roger Salengro
-
Lyon, France, 69004
- Centre de Médecine du Sommeil et des Maladies respiratoires - Centre Hospitalier de la Croix Rousse - Hospices Civils de Lyon
-
Marseille, France, 13005
- Service de neurophysiologie clinique - centre du sommeil - Hôpital de la Timone
-
Montpellier, France, 34295
- Service de Neurologie - Troubles du Sommeil Hôpital Gui de Chauliac
-
Nantes, France, 44 093
- Laboratoire d'Explorations Fonctionnelles Neurologiques, CHU de Nantes
-
Paris, France, 75 181
- Centre du Sommeil et de la vigilance - Centre de référence Hypersomnies rares - Hôpital de l'Hôtel Dieu
-
Paris, France, 75018
- Service de Physiologie Explorations fonctionnelles Hôpital Bichat Claude Bernard
-
Paris, France, 75651
- Service des pathologies du sommeil Hôpital Pitié-Salpêtrière
-
Paris, France
- Centre pédiatrique des pathologies du sommeil APHP CHU Robert Debré - Paris
-
Poitiers, France, 86000
- Service de Neurophysiologie Clinique et Centre du Sommeil, CHU de Poitiers
-
Strasbourg, France, 67 091
- Centre des Troubles du Sommeil, Hospices Civils de Strasbourg
-
Toulouse, France, 31059
- Explorations Neurophysiologiques, Hôpital Pierre Paul Riquet, CHU Toulouse Purpan
-
Tours, France, 37044
- Centre du Sommeil du Service de Neurologie et de Neurophysiologie Clinique - CHRU Bretonneau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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:
- 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
- a bank " child control' whose age is less than 18 years: may be composed of friends and cousins of included narcoleptic children.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adult Case Group
Adults with type 1 narcolepsy according to the ICSD3
|
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. |
Adult Control Group
Parents, cousins and / or friends of included narcoleptic adult patients, at least 18 years old and not suffering from narcolepsy.
|
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. |
Children Case Group
Children with type 1 narcolepsy according to the OCSD3
|
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. |
Children Control Group
Close friends and cousins of included narcoleptic children, minor and not suffering from narcolepsy.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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").
|
45 minutes (time to answering the questionnaire)
|
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).
|
45 minutes (time to answering the questionnaire)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL18_0314
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Narcolepsy
-
University of Dublin, Trinity CollegeSt. James's Hospital, IrelandSuspendedNarcolepsy | Hypersomnolence | Narcolepsy Type 1 | Narcolepsy Without Cataplexy | Narcolepsy With Cataplexy | Narcolepsy 1 | Narcolepsy and HypersomniaIreland
-
Northwestern UniversityActive, not recruitingNarcolepsy | Narcolepsy Type 1 | Narcolepsy Without Cataplexy | Narcolepsy With Cataplexy | Narcolepsy Type 2United States
-
NLS PharmaceuticsCompletedNarcolepsy | Narcolepsy Without Cataplexy | Narcolepsy With CataplexyUnited States
-
Boston Children's HospitalAmerican Academy of Sleep MedicineRecruitingIdiopathic Hypersomnia | Narcolepsy Type 1 | Narcolepsy Type 2United States
-
NLS PharmaceuticsNot yet recruitingNarcolepsy Type 1 | Narcolepsy With Cataplexy
-
TakedaRecruitingNarcolepsy Type 1 | Narcolepsy Type 2Spain, Germany, United States, Italy, Netherlands, Japan, France, Norway, Australia, Finland, Switzerland, Sweden
-
Northwestern UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedNarcolepsy | Narcolepsy Without Cataplexy | Narcolepsy With CataplexyUnited States
-
BioprojetActive, not recruitingNarcolepsy Without Cataplexy | Narcolepsy With CataplexyFrance, Italy, Russian Federation, Finland, Netherlands
-
TakedaTerminatedNarcolepsy Type 1 (NT1) | Narcolepsy Type 2 (NT2)China, United States, Korea, Republic of, France, Italy, Finland, Spain, Czechia, Canada, Japan, Hungary, Netherlands
-
Emory UniversityNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingIdiopathic Hypersomnia | Narcolepsy Without Cataplexy | Narcolepsy With CataplexyUnited States
Clinical Trials on Questionnaire (Adult)
-
Gazi UniversityEnrolling by invitation
-
Massachusetts General HospitalShriners Hospitals for ChildrenCompleted
-
Centre Hospitalier Universitaire de Saint EtienneNational Cancer Institute, FranceCompleted
-
Ege UniversityRecruitingEpileptic Children,Sleep Disturbances,Maladaptive BehaviorsTurkey
-
CHU de ReimsUnknownPostnatal DepressionFrance
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMental Health DisordersCongo
-
Janssen-Cilag Ltd.,ThailandCompleted
-
Murphy, Michael P., MDIndiana University School of MedicineUnknownPeripheral Vascular DiseasesUnited States
-
University Hospital Inselspital, BerneCompletedLeft Ventricular Assist DeviceSwitzerland
-
National and Kapodistrian University of AthensUnknownMyocardial InfarctionGreece