A Study to Collect Information of People With Narcolepsy in Spain

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

214 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-18

Study Completion Date

2022-11-04

Brief Summary

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This study aims to review information of people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day including falling asleep suddenly. Study doctors will review the medical records of the participants from sleep clinics in Spain. They will do this from 1 year before the participant was diagnosed with narcolepsy up to the start of this study.

Participants will visit the sleep clinic once. During this visit, the study doctors will carry out a short medical exam. Participants will also complete a few questionnaires during this visit. If participants cannot visit the clinic for any reason, the clinic staff will arrange a phone call instead.

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Detailed Description

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This is a non-interventional, cross-sectional study with retrospective medical chart review conducted in public and private Spanish sleep clinics, to describe the management of adult participants diagnosed with narcolepsy defined by ICDS-3 in real world practice.

This study will enroll approximately 196 participants (137 with NT1 and 59 with NT2). Participants will be enrolled in 2 cohorts:

* Cohort A: NT1 Participants
* Cohort B: NT2 Participants

The data will be collected retrospectively through clinical records and at study visit (clinical and demographic data, and participant related outcomes \[PRO\]) in an electronic case report form (eCRF).

This multi-center study will be conducted in Spain. The overall duration of this study is approximately 24 months. Participants will attend a single visit in the participating centers. In the event of a possible outbreak of coronavirus disease 2019 (COVID-19) participants will have a telepathic visits, the invitation to participate, the obtention of participant's informed consent and the collection of participant's questionnaires will be carried out remotely (by phone or via email).

Conditions

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Narcolepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Narcolepsy Type 1

Participants with confirmed diagnosis of narcolepsy type 1 (NT1) defined by the International Classification of Sleep Disorders, Third Edition (ICDS-3) will be observed for up to 16 months.

No interventions assigned to this group

Narcolepsy Type 2

Participants with confirmed diagnosis of narcolepsy type 2 (NT2) defined by the ICDS-3 will be observed for up to 16 months.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. With confirmed diagnosis of narcolepsy defined by ICDS-3.
2. With at least 1-year follow-up with data available at the participating site after initial narcolepsy diagnosis and before study inclusion.
3. With data available at the participant site at least 1-year before first narcolepsy diagnosis.
4. Capable to fulfill the study questionnaires.

Exclusion Criteria

1. Participating in a clinical trial (less than or equal to \[\<=\] 12 months).
2. With any serious degenerative disease (Alzheimer, Parkinson or epilepsy) or psychiatric condition.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No