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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05373979
Recruitment Status : Recruiting
First Posted : May 13, 2022
Last Update Posted : June 1, 2022
Sponsor:
Collaborators:
National Jewish Health
Geisinger Clinic
The Hospital for Sick Children
Stanford University
Information provided by (Responsible Party):
Kiran Maski, Boston Children's Hospital

Study Description
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Brief 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.

Condition or disease
Narcolepsy Obstructive Sleep Apnea

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

  • 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 Design
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Study Type : Observational
Estimated Enrollment : 340 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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Group/Cohort
Narcolepsy
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)


Outcome Measures
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Primary Outcome Measures :
  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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients (and a parent/guardian) with an established narcolepsy type 1, narcolepsy type 2, or OSA diagnoses ages 9-17 years.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Gillian Heckler 617-919-6212 Gillian.Heckler@childrens.harvard.edu

Locations
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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         
Sponsors and Collaborators
Boston Children's Hospital
National Jewish Health
Geisinger Clinic
The Hospital for Sick Children
Stanford University
Investigators
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Principal Investigator: Kiran Maski, MD, MPH Boston Children's Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Kiran Maski, Principal Investigator, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT05373979    
Other Study ID Numbers: IRB-A00029346
First Posted: May 13, 2022    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers outside of Boston Children's Hospital.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Narcolepsy
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Disorders of Excessive Somnolence
Mental Disorders