NarcolepsyNCT03765892
Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)
An observational study of Narcolepsy, run by Hospices Civils de Lyon at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy
- What is being tested?
- Questionnaire (Adult) and Questionnaire (Children)
- How many people
- 1,605 participants
- Where
- 18 sitesFrance
- Study dates
- 27 Feb 2020to 27 Feb 2023
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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:
Show all 9Show fewer
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Centre de médecine du Sommeil CHU d'Angers
Angers, 49033
Service d'Explorations Fonctionnelles du Système Nerveux, Clinique du Sommeil, CHU de Bordeaux Groupe Hospitalier Pellegrin
Bordeaux, 33076
Unité de sommeil pédiatrique - Hôpital femme Mère Enfant - Hospices civils de Lyon
Bron, 69677
Service de neurophysiologie clinique CHU de Dijon
Dijon, 21 079
Service de physiologie et Exploration fonctionnelle - Unité du Sommeil Hôpital Raymond Poincarré
Garches, 92 380
Service de Neurophysiologie Clinique, Hôpital Roger Salengro
Lille, 59037
Centre de Médecine du Sommeil et des Maladies respiratoires - Centre Hospitalier de la Croix Rousse - Hospices Civils de Lyon
Lyon, 69004
Service de neurophysiologie clinique - centre du sommeil - Hôpital de la Timone
Marseille, 13005
Service de Neurologie - Troubles du Sommeil Hôpital Gui de Chauliac
Montpellier, 34295
Laboratoire d'Explorations Fonctionnelles Neurologiques, CHU de Nantes
Nantes, 44 093
Centre du Sommeil et de la vigilance - Centre de référence Hypersomnies rares - Hôpital de l'Hôtel Dieu
Paris, 75 181
Service de Physiologie Explorations fonctionnelles Hôpital Bichat Claude Bernard
Paris, 75018
Service des pathologies du sommeil Hôpital Pitié-Salpêtrière
Paris, 75651
Centre pédiatrique des pathologies du sommeil APHP CHU Robert Debré - Paris
Paris
Service de Neurophysiologie Clinique et Centre du Sommeil, CHU de Poitiers
Poitiers, 86000
Centre des Troubles du Sommeil, Hospices Civils de Strasbourg
Strasbourg, 67 091
Explorations Neurophysiologiques, Hôpital Pierre Paul Riquet, CHU Toulouse Purpan
Toulouse, 31059
Centre du Sommeil du Service de Neurologie et de Neurophysiologie Clinique - CHRU Bretonneau
Tours, 37044
About this study
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.
Read more
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.
- Conditions
- Narcolepsy
- Being tested
- Questionnaire (Adult), Questionnaire (Children)
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire (Adult)Other
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.
Questionnaire (Children)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult Case Group | Adults with type 1 narcolepsy according to the ICSD3 Receives: Other: Questionnaire (Adult) | |
| Adult Control Group | Parents, cousins and / or friends of included narcoleptic adult patients, at least 18 years old and not suffering from narcolepsy. Receives: Other: Questionnaire (Adult) | |
| Children Case Group | Children with type 1 narcolepsy according to the OCSD3 Receives: Other: Questionnaire (Children) | |
| Children Control Group | Close friends and cousins of included narcoleptic children, minor and not suffering from narcolepsy. Receives: Other: Questionnaire (Children) |
What is being measured
The primary outcome is the main question the study is designed to answer.
For adult : distribution of professional situations
Distribution of professional situations in narcoleptic adult patients and related non-narcoleptic topics (employed, unemployed, student, retired, housewife/husband). (data collection form "professional situation").
Measured: 45 minutes (time to answering the questionnaire)
For children : proportion of children who repeated a grade
Proportion of children who repeated a grade in narcoleptic children and non-narcoleptic control children ("school status" data collection form).
Measured: 45 minutes (time to answering the questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start27 Feb 2020
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 1,605 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
- NCT03765892
- Sponsor's protocol ID
- 69HCL18_0314
- Status last verified
- Apr 2023
- First submitted
- 4 Dec 2018
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mazza S, Fort E, Martel N, Ricordeau F, Bastuji H, Arnulf I, Barateau L, Bourgin P, Dauvilliers Y, Debs R, Dodet P, Dudoignon B, Franco P, Hartley S, Lambert I, Lecendreux M, Leclair-Visonneau L, Leger D, Lemesle-Martin M, Leotard A, Leu-Semenescu S, Limousin N, Lopez R, Meslier N, Micoulaud-Franchi JA, Charley-Mocana C, d'Ortho MP, Philip P, Ruppert E, de La Tullaye S, Brigandet M, Charbotel B, Rolland B, Peter-Derex L. The hidden burden of narcolepsy type 1: Discordance in psychobehavioral symptoms between patient self-reports and reports from close family members and friends. Sleep Med. 2026 Aug;144:108969. doi: 10.1016/j.sleep.2026.108969. Epub 2026 Apr 19.
PubMed 42035556Peter-Derex L, Fort E, Putois B, Martel N, Ricordeau F, Bastuji H, Arnulf I, Barateau L, Bourgin P, Dauvilliers Y, Debs R, Dodet P, Dudoignon B, Franco P, Hartley S, Lambert I, Lecendreux M, Leclair-Visonneau L, Leger D, Lemesle-Martin M, Leotard A, Leu-Semenescu S, Limousin N, Lopez R, Meslier N, Micoulaud-Franchi JA, Charley-Mocana C, d'Ortho MP, Philip P, Ruppert E, de La Tullaye S, Brigandet M, Margier J, Rolland B, Charbotel B, Mazza S. Effort/reward imbalance and comorbidities burden in academic and professional careers of patients with narcolepsy type 1. J Clin Sleep Med. 2025 Jun 1;21(6):983-997. doi: 10.5664/jcsm.11598.
PubMed 39943847
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)
- ClinicalTrials.gov ID
- NCT03765892
- Acronym / sponsor ID
- 69HCL18_0314
- Conditions
- Narcolepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,605 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 5 Dec 2018 (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, 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult Case Group | – | Other: Questionnaire (Adult)Adults with type 1 narcolepsy according to the ICSD3 |
| Adult Control Group | – | Other: Questionnaire (Adult)Parents, cousins and / or friends of included narcoleptic adult patients, at least 18 years old and not suffering from narcolepsy. |
| Children Case Group | – | Other: Questionnaire (Children)Children with type 1 narcolepsy according to the OCSD3 |
| Children Control Group | – | Other: Questionnaire (Children)Close friends and cousins of included narcoleptic children, minor and not suffering from narcolepsy. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
- At least one person close to the case (cousins, close friends ...).
Key exclusion criteria (9 listed)
- 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.
- Person refusing 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 |
|---|---|---|
| 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. | Other | Adult Case Group, Adult Control Group |
| 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. | Other | Children Case Group, Children Control Group |
Primary outcome
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").
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).
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 18 Apr 2023.
- Derived from this study: PubMed 42035556Mazza S, Fort E, Martel N, Ricordeau F, Bastuji H, Arnulf I, Barateau L, Bourgin P, Dauvilliers Y, Debs R, Dodet P, Dudoignon B, Franco P, Hartley S, Lambert I, Lecendreux M, Leclair-Visonneau L, Leger D, Lemesle-Martin M, Leotard A, Leu-Semenescu S, Limousin N, Lopez R, Meslier N, Micoulaud-Franchi JA, Charley-Mocana C, d'Ortho MP, Philip P, Ruppert E, de La Tullaye S, Brigandet M, Charbotel B, Rolland B, Peter-Derex L. The hidden burden of narcolepsy type 1: Discordance in psychobehavioral symptoms between patient self-reports and reports from close family members and friends. Sleep Med. 2026 Aug;144:108969. doi: 10.1016/j.sleep.2026.108969. Epub 2026 Apr 19.
- Derived from this study: PubMed 39943847Peter-Derex L, Fort E, Putois B, Martel N, Ricordeau F, Bastuji H, Arnulf I, Barateau L, Bourgin P, Dauvilliers Y, Debs R, Dodet P, Dudoignon B, Franco P, Hartley S, Lambert I, Lecendreux M, Leclair-Visonneau L, Leger D, Lemesle-Martin M, Leotard A, Leu-Semenescu S, Limousin N, Lopez R, Meslier N, Micoulaud-Franchi JA, Charley-Mocana C, d'Ortho MP, Philip P, Ruppert E, de La Tullaye S, Brigandet M, Margier J, Rolland B, Charbotel B, Mazza S. Effort/reward imbalance and comorbidities burden in academic and professional careers of patients with narcolepsy type 1. J Clin Sleep Med. 2025 Jun 1;21(6):983-997. doi: 10.5664/jcsm.11598.
- Individual participant dataSharing planned: No
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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.
18 sites 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 18 sites 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 10 inclusion and 9 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
For adult : distribution of professional situations (time frame: 45 minutes (time to answering the questionnaire)). The study lists 2 primary outcomes in all. 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 NCT03765892, which also lists 2 linked publications.
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 18 Apr 2023.