Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-02

Study Completion Date

2024-05-30

Brief Summary

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The purpose of this study is to test a pediatric narcolepsy patient reported outcomes tool to assess pediatric narcolepsy symptoms and their effect on daily functioning and quality of life. The goal is to develop a clinical survey that can improve the care of pediatric narcolepsy.

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Detailed Description

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WHO IS ELIGIBLE?

* Children and adolescents with narcolepsy between the ages of 9-17 years
* Diagnosis must be verified by a signed letter from physician in order to participate
* Participants must be able to understand the purpose of the study

PARTICIPATION DETAILS

* Upon enrollment participants will receive an email containing a link to complete HIPAA compliant online surveys about narcolepsy symptoms, quality of life, and daily function. Surveys should take no more than 30 minutes.
* One week later, some participants will receive another email with a link to complete a 10-minute follow up survey

Conditions

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Narcolepsy Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Narcolepsy

Narcolepsy type 1 (NT1 or narcolepsy with cataplexy) and Narcolepsy type 2 (NT2 or narcolepsy without cataplexy)

No interventions assigned to this group

Obstructive Sleep Apnea

mild to moderate obstructive sleep apnea (OSA; obstructive AHI of 1-15/hour)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Children and adolescents ages 9-17
* Have a diagnosis of narcolepsy type 1, narcolepsy type 2, or mild to moderate obstructive sleep apnea (OSA)

Exclusion Criteria

* A history of visual or hearing impairment
* A co-morbid neurodevelopmental disorder such as autism or schizophrenia
* No access to computer/tablet/smart phone to complete questionnaires

Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No