Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0+
SponsorTakeda
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Participants with NT1 and NT2 from Spain.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
No intervention
Other interventionAs this is an observational study, no intervention will be administered.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Core Group1 intervention
Group B: Supplementary Group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 1 year2
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.
Time frame
Up to 1 year3
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.
Time frame
Up to 1 year4
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.
Time frame
Up to 1 yearSecondary outcomes
1
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Diagnosis
Time frame
Up to approximately 10 years2
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Diagnosis
Time frame
Up to approximately 10 years3
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Symptom Onset
Time frame
Up to approximately 10 years4
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Symptom Onset
Time frame
Up to approximately 10 years Source ClinicalTrials.gov