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Recruiting NCT07299097

Epidemiology of Narcolepsy Type 1 and Type 2 in Spain

— Observational Narcolepsy Type 1 Narcolepsy Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Narcolepsy Type 1, Narcolepsy Type 2. Basic parameters: from 0 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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).

Interventions

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

Primary outcome measures

  • Core Group: Prevalence of Participants With NT1 and NT2 per 100,000 Population [Time frame: 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]
  • Core Group: Prevalence of Paediatric/Adolescent Participants With NT1 and NT2 per 100,000 Paediatric/Adolescent Population [Time frame: 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]
  • Core Group: Prevalence of Female Participants With NT1 and NT2 per 100,000 Females Population [Time frame: Up to 1 year]
  • Core Group: Incidence of NT1 and NT2 per 100,000 Population [Time frame: Up to 2 years]
  • Core Group: Incidence of NT1 and NT2 per 100,000 Adult Population [Time frame: 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]
  • Core Group: Incidence of Male NT1 and NT2 per 100,000 Male Population [Time frame: Up to 2 years]
  • Core Group: Incidence of Female NT1 and NT2 per 100,000 Female Population [Time frame: Up to 2 years]
Secondary outcome measures (12)
  • Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Diagnosis [Time frame: 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]
  • Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Symptom Onset [Time frame: 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]
  • Core Group: Percentage Change in NT1 and NT2 Prevalence Over Past 10 Years [Time frame: 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]
  • Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Prevalence Over Past 10 Years [Time frame: Up to 10 years]
  • Core Group: Percentage Change in NT1 and NT2 Incidence Over Past 10 Years [Time frame: Up to 10 years]
  • Core Group: Percentage Change in Adult NT1 and NT2 Incidence Over Past 10 Years [Time frame: 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]
  • Core Group: Diagnostic Delay for Incident Participants with NT1 and NT2 [Time frame: Up to approximately 10 years]
  • Core Group: Diagnostic Delay for Incident Adult Participants with NT1 and NT2 [Time frame: Up to approximately 10 years]

Eligibility criteria

\- 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

1\. 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 10 centers
  • Hospital General de Castellón — Castellon
  • Hospital de Navarra — Pamplona
  • Hospital de la Ribera — Alzira
  • Hospital Vall d'Hebrón — Barcelona
  • Hospital Clinic de Barcelona — Barcelona
  • Hospital Virgen de las Nieves — Granada
  • Hospital Clínico San Carlos — Madrid
  • Hospital La Paz — Madrid
  • … and 2 more centers

Identifiers

NCT: NCT07299097 · TAK-861-4006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗