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De klinische studie NCT07299097 (HYPNOS) voor Narcolepsie type 1, Narcolepsie type 2 is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Takeda PharmaceuticalEpidemiology of Narcolepsy Type 1 and Type 2 in Spain (HYPNOS) 100
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De klinische studie NCT07299097 (HYPNOS) is een observationeel studie bij Narcolepsie type 1, Narcolepsie type 2 met de status rekruterend. Het doel is om 100 deelnemers te includeren vanaf 2 december 2025. De studie wordt geleid door Takeda Pharmaceutical en de voltooiing is gepland op 30 mei 2026. Laatste update op ClinicalTrials.gov: 5 maart 2026.
Beknopte samenvatting
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 ti...Toon meer
Uitgebreide beschrijving
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).
Officiële titel
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
Aandoeningen
Narcolepsie type 1Narcolepsie type 2Andere studie-ID's
- HYPNOS
- TAK-861-4006
NCT-ID
Startdatum (Werkelijk)
2025-12-02
Laatste update geplaatst
2026-03-05
Verwachte einddatum
2026-05-30
Inschrijving (Geschat)
100
Studietype
Observationeel
Status
Rekruterend
Trefwoorden
Drug therapy
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
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. | GEEN INTERVENTIE 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. | GEEN INTERVENTIE As this is an observational study, no intervention will be administered. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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: 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 | |
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Minimumleeftijd
0 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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.
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.
Takeda PharmaceuticalCentraal Contactpersoon
Contact: Takeda Contact, +1-877-825-3327, [email protected]
10 Studielocaties in 1 landen
Castellon
Hospital General de Castellón, Castellon, Castellon, 12004, Spain
Nog niet rekruterend
Navarre
Hospital de Navarra, Pamplona, Navarre, 31008, Spain
Nog niet rekruterend
Valencia
Hospital de la Ribera, Alzira, Valencia, 46600, Spain
Nog niet rekruterend
Hospital Vall d'Hebrón, Barcelona, 8035, Spain
Nog niet rekruterend
Hospital Clinic de Barcelona, Barcelona, 8036, Spain
Rekruterend
Hospital Virgen de las Nieves, Granada, 18014, Spain
Nog niet rekruterend
Hospital Clínico San Carlos, Madrid, 28040, Spain
Actief, niet rekruterend
Hospital La Paz, Madrid, 28046, Spain
Nog niet rekruterend
Hospital Virgen Macarena, Seville, 41009, Spain
Rekruterend
Álava
Hospital de Araba, Vitoria-Gasteiz, Álava, 1009, Spain
Nog niet rekruterend