Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale

Obstructive Sleep Apnea Clinical Trial

— PN-PROS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373979
• Other study ID #: IRB-A00029346
• Status: Recruiting
• Start date: April 2, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2022
• Source: Boston Children's Hospital
• Contact: Gillian Heckler
• Phone: 617-919-6212
• Email: Gillian.Heckler[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Narcolepsy
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Boston Children's Hospital	Geisinger Clinic, National Jewish Health, Stanford University, The Hospital for Sick Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survey Validation	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).	2 Years