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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

Tracking Information
First Submitted Date May 10, 2022
First Posted Date May 13, 2022
Last Update Posted Date June 1, 2022
Actual Study Start Date April 2, 2019
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2022)		 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale
Official Title Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Narcolepsy
  • Obstructive Sleep Apnea
Intervention Not Provided
Study Groups/Cohorts
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 10, 2022)		 340
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 9 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Gillian Heckler 617-919-6212 Gillian.Heckler@childrens.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05373979
Other Study ID Numbers IRB-A00029346
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Current Responsible Party Kiran Maski, Boston Children's Hospital
Original Responsible Party Same as current
Current Study Sponsor Boston Children's Hospital
Original Study Sponsor Same as current
Collaborators
  • National Jewish Health
  • Geisinger Clinic
  • The Hospital for Sick Children
  • Stanford University
Investigators
Principal Investigator: Kiran Maski, MD, MPH Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date May 2022