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NCT Number: NCT07299097

Epidemiology of Narcolepsy Type 1 and Type 2 in Spain

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.

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Key information

Conditions

Narcolepsy Type 1 Narcolepsy Type 2

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Castellón, Castellon, Spain

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Core Group:

Inclusion criteria

  • 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.
  • Any age, ethnicity and nationality.
  • 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

  • NT1 or NT2 participants who do not reside in the hospitals' reference areas.
  • Supplementary Group:

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

As this is an observational study, no intervention will be administered.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Secondary outcomes

  1. Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Diagnosis

    Time frame: Up to approximately 10 years

  2. Core Group: Proportion of Participants as per Age with NT1 and NT2 at Diagnosis

    Time frame: Up to approximately 10 years

  3. Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Symptom Onset

    Time frame: Up to approximately 10 years

  4. Core Group: Proportion of Participants as per Age with NT1 and NT2 at Symptom Onset

    Time frame: Up to approximately 10 years

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Core Group: Percentage Change in Diagnostic Delay for Participants With NT1 and NT2 Over Past 10 Years

    Time frame: Up to 10 years

  17. Core Group: Percentage Change in Diagnostic Delay for Adult Participants With NT1 and NT2 Over Past 10 Years

    Time frame: Up to 10 years

  18. 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

  19. Core Group: Percentage Change in Diagnostic Delay for Male Participants With NT1 and NT2 Over Past 10 Years

    Time frame: Up to 10 years

  20. Core Group: Percentage Change in Diagnostic Delay for Female Participants With NT1 and NT2 Over Past 10 Years

    Time frame: Up to 10 years

  21. 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

  22. 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

  23. Supplementary Study: Age at Symptom Onset

    Time frame: On a day of survey (any 1 day) during the study for each participant

  24. Supplementary Study: Age at Diagnosis

    Time frame: On a day of survey (any 1 day) during the study for each participant

  25. 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

  26. 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

  27. 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

  28. 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

  29. Supplementary Study: Proportion of Participants with Comorbidities

    Time frame: On a day of survey (any 1 day) during the study for each participant

  30. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Acronym: HYPNOS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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