Epidemiology of Narcolepsy Type 1 and Type 2 in Spain (HYPNOS)

May 12, 2026 updated by: Takeda
The main purpose of this study is to find out how many people in Spain have been diagnosed with narcolepsy type 1 and type 2, and how many new participants are diagnosed each year. Narcolepsy is a rare sleep disorder that causes excessive daytime sleepiness. The researchers will look at medical records from hospitals across Spain to count participants with these conditions and understand patterns in diagnosis over time.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim is to do epidemiology study in the core group thus the enrolment number is not applicable to this group, however approximately100 participants in the supplementary group (online survey).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Barcelona, Spain, 8036
        • Recruiting
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 8035
        • Not yet recruiting
        • Hospital Vall d'Hebron
      • Granada, Spain, 18014
        • Not yet recruiting
        • Hospital Virgen de las Nieves
      • Madrid, Spain, 28046
        • Not yet recruiting
        • Hospital La Paz
      • Madrid, Spain, 28040
        • Active, not recruiting
        • Hospital Clinico San Carlos
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Virgen Macarena
    • Castellon
      • Castellon, Castellon, Spain, 12004
        • Not yet recruiting
        • Hospital General de Castellón
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Not yet recruiting
        • Hospital de Navarra
    • Valencia
      • Alzira, Valencia, Spain, 46600
        • Not yet recruiting
        • Hospital de La Ribera
    • Álava
      • Vitoria-Gasteiz, Álava, Spain, 1009
        • Not yet recruiting
        • Hospital de Araba

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with NT1 and NT2 from Spain.

Description

- Core Group:

Inclusion Criteria:

  1. Participants with NT1 or NT2 following International Classification of Sleep Disorders, 3rd Edition (ICSD-3) or ICSD-3 text revision (ICSD-3-TR) criteria who are alive at any point during 2023 or 2024.
  2. Any age, ethnicity and nationality.
  3. Treated / under follow-up in the study site and residing in the hospitals' reference areas. Consideration will be given if participants have changed their address or reached adulthood.

Exclusion Criteria

1. NT1 or NT2 participants who do not reside in the hospitals' reference areas.

- Supplementary Group:

Inclusion criteria:

  1. Confirmation to have a diagnosis of NT1 or NT2 by a specialist.
  2. Participants greater than equal to (≥) 18 years or parents of narcolepsy participants under 18 years of age.
  3. Any gender, ethnicity or nationality.
  4. Residence in Spain.

Exclusion criteria:

1. Participants without a confirmed NT1 or NT2 diagnosis by a specialist.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Core Group
Participants with Narcolepsy Type (NT1) and Narcolepsy Type (NT2) of any age, ethnicity and nationality, treated / under follow-up in approximately 10 Spanish public hospitals, who are alive at any point during 2023 or 2024, residing in the hospitals' reference areas will be retrospectively observed through chart reviews. The retrospective data for up to approximately 10 years would be assessed.
Other: No intervention
As this is an observational study, no intervention will be administered.
Supplementary Group
Participants with NT1 and NT2 from Spain will undergo an online survey conducted in collaboration with a patient advocacy group.
Other: No intervention
As this is an observational study, no intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Core Group: Prevalence of Participants With NT1 and NT2 per 100,000 Population
Time Frame: Up to 1 year
The overall study prevalence will be calculated as the number of participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of people living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Up to 1 year
Core Group: Prevalence of Adult Participants With NT1 and NT2 per 100,000 Adult Population
Time Frame: Up to 1 year
The overall study prevalence will be calculated as the number of adult participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of adult people living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Up to 1 year
Core Group: Prevalence of Paediatric/Adolescent Participants With NT1 and NT2 per 100,000 Paediatric/Adolescent Population
Time Frame: Up to 1 year
The overall study prevalence will be calculated as number of diagnosed paediatric/adolescent participants from all public hospitals divided by number of paediatric/adolescent living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Up to 1 year
Core Group: Prevalence of Male Participants With NT1 and NT2 per 100,000 Male Population
Time Frame: Up to 1 year
The overall study prevalence will be calculated as the number of male participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of males living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Up to 1 year
Core Group: Prevalence of Female Participants With NT1 and NT2 per 100,000 Females Population
Time Frame: Up to 1 year
The overall study prevalence will be calculated as the number of female participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of females living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Up to 1 year
Core Group: Incidence of NT1 and NT2 per 100,000 Population
Time Frame: Up to 2 years
The incidence for both the years will be calculated as (average of both years). And for each year, the number of participants diagnosed for the first time from all hospitals divided by number of people living in the areas served by the hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Up to 2 years
Core Group: Incidence of NT1 and NT2 per 100,000 Adult Population
Time Frame: Up to 2 years
The incidence for both the years will be calculated as (average of both years) and for each year, the number of adult participants diagnosed for the first time from all hospitals divided by number of adults living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Up to 2 years
Core Group: Incidence of Paediatric/Adolescent NT1 and NT2 per 100,000 Paediatric/Adolescent Population
Time Frame: Up to 2 years
The incidence for both the years will be calculated as (average of both years) and for each year, the number of paediatric/adolescent participants diagnosed for the first time from all hospitals divided by number of paediatric/adolescent living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Up to 2 years
Core Group: Incidence of Male NT1 and NT2 per 100,000 Male Population
Time Frame: Up to 2 years
The incidence for both the years will be calculated as (average of both years) and for each year, the number of male participants diagnosed for the first time from all hospitals divided by number of male participants living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Up to 2 years
Core Group: Incidence of Female NT1 and NT2 per 100,000 Female Population
Time Frame: Up to 2 years
The incidence for both the years will be calculated as (average of both years) and for each year, the number of female participants diagnosed for the first time from all hospitals divided by number of female participants living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Up to 2 years
Supplementary Group: Number of Participants with NT1 and NT2 who Attend Regular Follow-ups
Time Frame: On a day of survey (any 1 day) during the study for each participant
Proportion of Participants with NT1 and NT2 in Spain who attended regular follow ups at only public hospitals, only private hospitals, and both private and public hospitals will be reported.
On a day of survey (any 1 day) during the study for each participant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Diagnosis
Time Frame: Up to approximately 10 years
Up to approximately 10 years
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Diagnosis
Time Frame: Up to approximately 10 years
Up to approximately 10 years
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Symptom Onset
Time Frame: Up to approximately 10 years
Up to approximately 10 years
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Symptom Onset
Time Frame: Up to approximately 10 years
Up to approximately 10 years
Core Group: Percentage Change in NT1 and NT2 Prevalence Over Past 10 Years
Time Frame: Up to 10 years
The overall prevalence will be calculated as the number of participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of people living in the areas served by these hospitals resulting in prevalence fraction. The overall percentage change of participant resulting from the above method will be reported.
Up to 10 years
Core Group: Percentage Change in Adult With NT1 and NT2 Prevalence Over Past 10 Years
Time Frame: Up to 10 years
The overall prevalence will be calculated as the number of adult participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of adult people living in the areas served by these hospitals resulting in a study prevalence fraction. The overall percentage change of participant resulting from the above method will be reported.
Up to 10 years
Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Prevalence Over Past 10 Years
Time Frame: Up to 10 years
The overall prevalence will be calculated as the number of paediatric/adolescent participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of paediatric/adolescent living in the areas served by these hospitals resulting in a study prevalence fraction. The overall percentage of participant resulting from the above method will be reported.
Up to 10 years
Core Group: Percentage Change in NT1 and NT2 Incidence Over Past 10 Years
Time Frame: Up to 10 years
The incidence will be calculated as number of participants diagnosed for the first time from all hospitals divided by number of people living in the areas served by these hospitals resulting in a study incidence fraction. The overall percentage change of participant resulting from the above method will be reported.
Up to 10 years
Core Group: Percentage Change in Adult NT1 and NT2 Incidence Over Past 10 Years
Time Frame: Up to 10 years
The incidence will be calculated as number of adult participants diagnosed for the first time from all hospitals divided by number of adults living in the areas served by these hospitals resulting in a study incidence fraction. The overall percentage change of participant resulting from the above method will be reported.
Up to 10 years
Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Incidence Over Past 10 Years
Time Frame: Up to 10 years
The incidence will be calculated as number of paediatric/adolescent participants diagnosed for the first time from all hospitals divided by number of paediatric/adolescent living in the areas served by these hospitals resulting in a study incidence fraction. The overall percentage of participant resulting from the above method will be reported.
Up to 10 years
Core Group: Diagnostic Delay for Incident Participants with NT1 and NT2
Time Frame: Up to approximately 10 years
Diagnostic delay means that cases that began to present symptoms in the years prior to one year and have not yet been diagnosed.
Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Adult Participants with NT1 and NT2
Time Frame: Up to approximately 10 years
Diagnostic delay means that cases that began to present symptoms in the years prior to one year and have not yet been diagnosed.
Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Paediatric/Adolescent Participants with NT1 and NT2
Time Frame: Up to approximately 10 years
Diagnostic delay means that cases that began to present symptoms in the years prior to one year and have not yet been diagnosed.
Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Male Participants with NT1 and NT2
Time Frame: Up to approximately 10 years
Diagnostic delay means that cases that began to present symptoms in the years prior to one year and have not yet been diagnosed.
Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Female Participants with NT1 and NT2
Time Frame: Up to approximately 10 years
Diagnostic delay means that cases that began to present symptoms in the years prior to one year and have not yet been diagnosed.
Up to approximately 10 years
Core Group: Percentage Change in Diagnostic Delay for Participants With NT1 and NT2 Over Past 10 Years
Time Frame: Up to 10 years
Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Adult Participants With NT1 and NT2 Over Past 10 Years
Time Frame: Up to 10 years
Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Paediatric/Adolescent Participants With NT1 and NT2 Over Past 10 Years
Time Frame: Up to 10 years
Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Male Participants With NT1 and NT2 Over Past 10 Years
Time Frame: Up to 10 years
Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Female Participants With NT1 and NT2 Over Past 10 Years
Time Frame: Up to 10 years
Up to 10 years
Supplementary Group: Proportion of Participants With NT1 and NT2 who Were Diagnosed at Public hospitals and Private Practices
Time Frame: On a day of survey (any 1 day) during the study for each participant
On a day of survey (any 1 day) during the study for each participant
Supplementary Group: Proportion of Participants who Choose to be Followed in Public, Private, or Both Types of Hospitals and Reasons
Time Frame: On a day of survey (any 1 day) during the study for each participant
On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants as per Speciality of the Doctor Visited First for Narcolepsy Symptoms
Time Frame: On a day of survey (any 1 day) during the study for each participant
On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants as per Speciality of the Doctor who Diagnosed Narcolepsy
Time Frame: On a day of survey (any 1 day) during the study for each participant
On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Number of Doctors Visited by Participant Prior to Receiving a Narcolepsy Diagnosis
Time Frame: On a day of survey (any 1 day) during the study for each participant
On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants With Misdiagnosis Prior to Narcolepsy Diagnosis
Time Frame: On a day of survey (any 1 day) during the study for each participant
On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants with Comorbidities
Time Frame: On a day of survey (any 1 day) during the study for each participant
On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants as per Place of Residence (Autonomous Community)
Time Frame: On a day of survey (any 1 day) during the study for each participant
On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Age at Symptom Onset
Time Frame: On a day of survey (any 1 day) during the study for each participant
On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Age at Diagnosis
Time Frame: On a day of survey (any 1 day) during the study for each participant
On a day of survey (any 1 day) during the study for each participant

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Takeda

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-861-4006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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