NarcolepsyNARCOWORKNCT03173378
Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
An observational study of Narcolepsy, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy
- What is being tested?
- Questionnaires
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2017to 10 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Type 1 and Type 2 narcoleptic patients and adult age-matched family members of the patients (1 or 2 control per patient)
Who may be able to join
- 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
Who cannot join
- uncertain diagnosis (for the "Narcoleptic Patients" Group)
- poor knowledge of the French language
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon
Lyon, 69004
About this study
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.
- Conditions
- Narcolepsy
- Being tested
- Questionnaires
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Participants will have to complete questionnaires to compare the distribution of occupational situations in narcoleptic patients and matched non-narcoleptic subjects (controls)
| Study group | Role | What they receive |
|---|---|---|
| Narcoleptic Patients | Type 1 and Type 2 narcoleptic adult patients usually followed at the Lyon Sleep Medicine and Respiratory Disease center Receives: Other: Questionnaires | |
| Control | Adult age-matched family members of the patients Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start3 Oct 2017
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173378
- Sponsor's protocol ID
- 69HCL17_0252
- Acronym
- NARCOWORK
- Status last verified
- Nov 2018
- First submitted
- 30 May 2017
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
White M, Charbotel B, Fort E, Bastuji H, Franco P, Putois B, Mazza S, Peter-Derex L. Academic and professional paths of narcoleptic patients: the Narcowork study. Sleep Med. 2020 Jan;65:96-104. doi: 10.1016/j.sleep.2019.07.020. Epub 2019 Aug 2.
PubMed 31739232
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
- ClinicalTrials.gov ID
- NCT03173378
- Acronym / sponsor ID
- NARCOWORK / 69HCL17_0252
- Conditions
- Narcolepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narcoleptic Patients | – | Other: QuestionnairesType 1 and Type 2 narcoleptic adult patients usually followed at the Lyon Sleep Medicine and Respiratory Disease center |
| Control | – | Other: QuestionnairesAdult age-matched family members of the patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 and Type 2 narcoleptic patients and adult age-matched family members of the patients (1 or 2 control per patient)
Key inclusion criteria (8 listed)
- Type 1 or Type 2 narcolepsy
- > 18 years
- Usually followed at the Lyon Sleep Medicine Center
- 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)
Key exclusion criteria (3 listed)
- uncertain diagnosis (for the "Narcoleptic Patients" Group)
- poor knowledge of the French language
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesParticipants will have to complete questionnaires to compare the distribution of occupational situations in narcoleptic patients and matched non-narcoleptic subjects (controls) | Other | Control, Narcoleptic Patients |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Derived from this study: PubMed 31739232White M, Charbotel B, Fort E, Bastuji H, Franco P, Putois B, Mazza S, Peter-Derex L. Academic and professional paths of narcoleptic patients: the Narcowork study. Sleep Med. 2020 Jan;65:96-104. doi: 10.1016/j.sleep.2019.07.020. Epub 2019 Aug 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupational situations (time frame: 30 to 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03173378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.