Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale


Currently there is no clinical tool to assess the broad symptoms of pediatric narcolepsy and their impact on daily functioning. We are a group of researchers from different academic hospitals testing a pediatric narcolepsy patient reported outcomes tool to assess pediatric narcolepsy symptoms and their effect on daily functioning and quality of life. Our goal is to develop a clinical survey that can improve the care of pediatric narcolepsy.

Full Title of Study: “Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2023

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 – If you sign up you will receive an email containing a link to complete HIPAA compliant online surveys about narcolepsy symptoms, quality of life, and daily function. Participation 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 – As a thank you for completing all surveys, we will send you a $50 gift card

Arms, Groups and Cohorts

  • Narcolepsy
    • Narcolepsy type 1 (NT1 or narcolepsy with cataplexy) and Narcolepsy type 2 (NT2 or narcolepsy without cataplexy)
  • Obstructive Sleep Apena
    • mild to moderate obstructive sleep apnea (OSA; obstructive AHI of 1-15/hour)

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Participating in This Clinical Trial

Inclusion Criteria

Children and adolescents with an established narcolepsy type 1, narcolepsy type 2, or mild to moderate obstructive sleep apnea (OSA) with an obstructive AHI of 1-15/hour. Age 9-17 years. Exclusion Criteria:

A history of visual or hearing impairment, have a co-morbid neurodevelopmental disorder including autism, or thought disorder such as schizophrenia, don't have a computer/tablet/smart phone access to complete questionnaires

Gender Eligibility: All

Minimum Age: 9 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boston Children’s Hospital
  • Collaborator
    • National Jewish Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kiran Maski, Principal Investigator – Boston Children’s Hospital
  • Overall Official(s)
    • Kiran Maski, MD, MPH, Principal Investigator, Boston Children’s Hospital
  • Overall Contact(s)
    • Gillian Heckler, 617-919-6212,

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