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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03173378
Other study ID # 69HCL17_0252
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 3, 2017
Est. completion date July 10, 2018

Study information

Verified date November 2018
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date July 10, 2018
Est. primary completion date July 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaires
Participants will have to complete questionnaires to compare the distribution of occupational situations in narcoleptic patients and matched non-narcoleptic subjects (controls)

Locations

Country Name City State
France Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon Lyon

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 Occupational situations 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
See also
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Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
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