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

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ClinicalTrials.gov Identifier: NCT03765892
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Narcolepsy Other: Questionnaire (Adult) Other: Questionnaire (Children)

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Study Type : Observational
Estimated Enrollment : 3600 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : February 27, 2023
Estimated Study Completion Date : February 27, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Adult Case Group
Adults with type 1 narcolepsy according to the ICSD3
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.


Adult Control Group
Parents, cousins and / or friends of included narcoleptic adult patients, at least 18 years old and not suffering from narcolepsy.
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.


Children Case Group
Children with type 1 narcolepsy according to the OCSD3
Other: 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.


Children Control Group
Close friends and cousins of included narcoleptic children, minor and not suffering from narcolepsy.
Other: 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.





Primary Outcome Measures :
  1. 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").

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765892


Contacts
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Contact: Laure PETER-DEREX, MD, PhD 04 72 07 17 69 ext +33 laure.peter-derex@chu-lyon.fr

Locations
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France
Centre de Médecine du Sommeil et des Maladies respiratoires - Centre Hospitalier de la Croix Rousse - Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Laure PETER-DEREX, MD, PhD    04 72 07 17 69 ext +33    laure.peter-derex@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03765892    
Other Study ID Numbers: 69HCL18_0314
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders