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

Boston Children's Hospital

Status: Completed

Conditions: Obstructive Sleep Apnea; Narcolepsy

Study type: Observational

Funder types: Other

Identifiers

NCT05373979

IRB-A00029346

Details and patient eligibility

About

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.

Full 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

Enrollment: 212 patients

Sex: All

Ages: 9 to 17 years old

Volunteers: No 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

Trial design

212 participants in 2 patient groups

Narcolepsy

Description:

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

Obstructive Sleep Apnea

Description:

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