Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale

Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05373979

Acronym

PN-PROS

Enrollment

212

Registered

2022-05-13

Start date

2019-04-02

Completion date

2024-05-30

Last updated

2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy, Obstructive Sleep Apnea

Brief summary

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Survey Validation	2 Years	To evaluate the content validity and reliability of the PN-PROs item pools through a field test of the item pools in a diverse, national sample of pediatric narcolepsy patients with a comparator group of pediatric mild obstructive sleep apnea patients (9-17 years).

Countries

United States

Outcome results