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Completed

NCT Number: NCT05373979

Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale

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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Key information

Conditions

Narcolepsy Apnea Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Survey Validation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Geisinger Clinic
  • National Jewish Health
  • Stanford University
  • The Hospital for Sick Children

Registry information

Official study title

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

Acronym: PN-PROS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 13, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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