Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)
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|ClinicalTrials.gov Identifier: NCT05373979|
Recruitment Status : Recruiting
First Posted : May 13, 2022
Last Update Posted : June 1, 2022
|Condition or disease|
|Narcolepsy Obstructive Sleep Apnea|
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
- 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
|Study Type :||Observational|
|Estimated Enrollment :||340 participants|
|Official Title:||Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)|
|Actual Study Start Date :||April 2, 2019|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
Narcolepsy type 1 (NT1 or narcolepsy with cataplexy) and Narcolepsy type 2 (NT2 or narcolepsy without cataplexy)
Obstructive Sleep Apnea
mild to moderate obstructive sleep apnea (OSA; obstructive AHI of 1-15/hour)
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05373979
|Contact: Gillian Heckler||617-919-6212||Gillian.Heckler@childrens.harvard.edu|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Gillian Heckler 617-919-6212 Gillian.Heckler@childrens.harvard.edu|
|Principal Investigator: Kiran Maski, MD, MPH|
|Principal Investigator:||Kiran Maski, MD, MPH||Boston Children's Hospital|