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

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: Recruiting
• Conditions: Narcolepsy Type 1; Narcolepsy Type 2
• Intervention / Treatment: Other: No intervention

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: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Core Group: Prevalence of Participants With NT1 and NT2 per 100,000 Population	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	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	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	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Diagnosis		Up to approximately 10 years
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Diagnosis		Up to approximately 10 years
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Symptom Onset		Up to approximately 10 years
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Symptom Onset		Up to approximately 10 years
Core Group: Percentage Change in NT1 and NT2 Prevalence Over Past 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	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	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	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	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	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	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	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	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	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	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		Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Adult Participants With NT1 and NT2 Over Past 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		Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Male Participants With NT1 and NT2 Over Past 10 Years		Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Female Participants With NT1 and NT2 Over Past 10 Years		Up to 10 years
Supplementary Group: Proportion of Participants With NT1 and NT2 who Were Diagnosed at Public hospitals and Private Practices		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		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		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		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		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		On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants with Comorbidities		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)		On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Age at Symptom Onset		On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Age at Diagnosis		On a day of survey (any 1 day) during the study for each participant

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
• To obtain more information on the study, click here/on this link.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Drug therapy
• Other Study ID 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