Идёт набор NCT07299097

Epidemiology of Narcolepsy Type 1 and Type 2 in Spain

— Наблюдательное Narcolepsy Type 1 Narcolepsy Type 2

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: No intervention.
Кому может быть актуально: Состояния в реестре: Narcolepsy Type 1, Narcolepsy Type 2. Базовые параметры: от 0 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

Core Group: Prevalence of Participants With NT1 and NT2 per 100,000 Population [Срок оценки: Up to 1 year]
Core Group: Prevalence of Adult Participants With NT1 and NT2 per 100,000 Adult Population [Срок оценки: Up to 1 year]
Core Group: Prevalence of Paediatric/Adolescent Participants With NT1 and NT2 per 100,000 Paediatric/Adolescent Population [Срок оценки: Up to 1 year]
Core Group: Prevalence of Male Participants With NT1 and NT2 per 100,000 Male Population [Срок оценки: Up to 1 year]
Core Group: Prevalence of Female Participants With NT1 and NT2 per 100,000 Females Population [Срок оценки: Up to 1 year]
Core Group: Incidence of NT1 and NT2 per 100,000 Population [Срок оценки: Up to 2 years]
Core Group: Incidence of NT1 and NT2 per 100,000 Adult Population [Срок оценки: Up to 2 years]
Core Group: Incidence of Paediatric/Adolescent NT1 and NT2 per 100,000 Paediatric/Adolescent Population [Срок оценки: Up to 2 years]
Core Group: Incidence of Male NT1 and NT2 per 100,000 Male Population [Срок оценки: Up to 2 years]
Core Group: Incidence of Female NT1 and NT2 per 100,000 Female Population [Срок оценки: Up to 2 years]

Вторичные конечные точки (12)

Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Diagnosis [Срок оценки: Up to approximately 10 years]
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Diagnosis [Срок оценки: Up to approximately 10 years]
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Symptom Onset [Срок оценки: Up to approximately 10 years]
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Symptom Onset [Срок оценки: Up to approximately 10 years]
Core Group: Percentage Change in NT1 and NT2 Prevalence Over Past 10 Years [Срок оценки: Up to 10 years]
Core Group: Percentage Change in Adult With NT1 and NT2 Prevalence Over Past 10 Years [Срок оценки: Up to 10 years]
Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Prevalence Over Past 10 Years [Срок оценки: Up to 10 years]
Core Group: Percentage Change in NT1 and NT2 Incidence Over Past 10 Years [Срок оценки: Up to 10 years]
Core Group: Percentage Change in Adult NT1 and NT2 Incidence Over Past 10 Years [Срок оценки: Up to 10 years]
Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Incidence Over Past 10 Years [Срок оценки: Up to 10 years]
Core Group: Diagnostic Delay for Incident Participants with NT1 and NT2 [Срок оценки: Up to approximately 10 years]
Core Group: Diagnostic Delay for Incident Adult Participants with NT1 and NT2 [Срок оценки: Up to approximately 10 years]

Критерии участия

\- Core Group:

Критерии включения

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.

Критерии исключения

1\. NT1 or NT2 participants who do not reside in the hospitals' reference areas.

\- Supplementary Group:

Критерии включения

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.