How common narcolepsy type 1 and type 2 are across Spain

Epidemiology of Narcolepsy Type 1 and Type 2 in Spain

This project will count how many people in Spain have narcolepsy type 1 or 2 and how many new cases are diagnosed each year using hospital records and an online survey.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 0 Years and up
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Locations: 10 sites (Castellon, Castellon and 9 other locations)
• Trial ID: NCT07299097 on ClinicalTrials.gov

What this trial studies

This observational study will review medical records from participating hospitals to identify patients who meet ICSD-3/ICSD-3‑TR criteria for narcolepsy type 1 or type 2 and who were alive during 2023 or 2024. The core component uses hospital catchment-area records to estimate prevalence and annual incidence, while a supplementary online survey aims to collect responses from about 100 adults or parents of affected minors with specialist-confirmed diagnoses across Spain. No treatments or interventions are given; researchers will aggregate diagnostic counts and timing to describe epidemiologic patterns over time. Patients who do not reside in the hospitals' reference areas are excluded from the core group.

Who should consider this trial

Good fit: Ideal participants are people of any age with a specialist-confirmed diagnosis of narcolepsy type 1 or 2 who are treated at the participating hospitals, or adults (or parents of minors) with confirmed diagnoses living in Spain for the online survey.

Not a fit: People without a specialist-confirmed diagnosis, those who do not reside in the hospitals' reference areas for the core group, or residents outside Spain for the supplementary survey are unlikely to be eligible or to receive direct benefit.

Why it matters

Potential benefit: If successful, the findings will provide clearer national estimates of how common narcolepsy is in Spain, helping healthcare planning and future research efforts.

How similar studies have performed: Epidemiologic surveys of narcolepsy in other countries have successfully estimated prevalence and incidence, though comprehensive national data for Spain have been limited.

Eligibility criteria

\- 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.

Where this trial is running

Castellon, Castellon and 9 other locations

• Hospital General de Castellón — Castellon, Castellon, Spain (Not_yet_recruiting)
• Hospital de Navarra — Pamplona, Navarre, Spain (Not_yet_recruiting)
• Hospital de la Ribera — Alzira, Valencia, Spain (Not_yet_recruiting)
• Hospital Vall d'Hebrón — Barcelona, Spain (Not_yet_recruiting)
• Hospital Clinic de Barcelona — Barcelona, Spain (Recruiting)
• Hospital Virgen de las Nieves — Granada, Spain (Not_yet_recruiting)
• Hospital Clínico San Carlos — Madrid, Spain (Active_not_recruiting)
• Hospital La Paz — Madrid, Spain (Not_yet_recruiting)
• Hospital Virgen Macarena — Seville, Spain (Recruiting)
• Hospital de Araba — Vitoria-Gasteiz, Álava, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: Takeda Contact

Conditions Narcolepsy Type 1; Narcolepsy Type 2; Drug therapy