Evaluation of Academic and Professional Trajectories of Narcoleptic Patients (NARCOWORK)

November 27, 2018 updated by: Hospices Civils de Lyon

Narcolepsy is a chronic, disabling condition 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 examined the impact of narcolepsy on patients' educational background, socio-professional integration, and quality of life. In particular, the factors of professional handicap related to the characteristics of the disease and the determinants of the insertion of the patients remain poorly known.

As a better understanding of these determinants could help to inform patients and guide them in their choices, NARCOWORK study aims at evaluating the academic and professional trajectories of a wide population of narcoleptic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 1 and Type 2 narcoleptic patients and adult age-matched family members of the patients (1 or 2 control per patient)

Description

Inclusion Criteria:

Group "Narcoleptic Patients":

  • Type 1 or Type 2 narcolepsy
  • > 18 years
  • Usually followed at the Lyon Sleep Medicine Center

Group "Control":

  • At least one member of each family of cases (siblings, cousins ...)
  • > 18 years and of the same age as the case if possible (+/- 5 years)
  • No narcolepsy

Exclusion Criteria:

  • uncertain diagnosis (for the "Narcoleptic Patients" Group)
  • poor knowledge of the French language
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Narcoleptic Patients
Type 1 and Type 2 narcoleptic adult patients usually followed at the Lyon Sleep Medicine and Respiratory Disease center
Other: Questionnaires
Participants will have to complete questionnaires to compare the distribution of occupational situations in narcoleptic patients and matched non-narcoleptic subjects (controls)
Control
Adult age-matched family members of the patients
Other: Questionnaires
Participants will have to complete questionnaires to compare the distribution of occupational situations in narcoleptic patients and matched non-narcoleptic subjects (controls)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occupational situations
Time Frame: 30 to 45 minutes
Participants will have to complete questionnaires to compare the distribution of occupational situations subjects (worker, unemployed, student, retired, housewife) in narcoleptic patients and matched non-narcoleptic subjects (controls)
30 to 45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2017

Primary Completion (Actual)

July 10, 2018

Study Completion (Actual)

July 10, 2018

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL17_0252

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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