Epidemiology of Narcolepsy Type 1 and Type 2 in Spain (HYPNOS)

Takeda

Status: Not yet enrolling

Conditions: Narcolepsy Type 2; Narcolepsy Type 1

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT07299097

TAK-861-4006

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

100 participants in 2 patient groups

Core Group

Description:

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.

Treatment:

Other: No intervention

Supplementary Group

Description:

Participants with NT1 and NT2 from Spain will undergo an online survey conducted in collaboration with a patient advocacy group.

Treatment:

Other: No intervention