Child and Adolescent Registry for Participants With Narcolepsy

August 13, 2024 updated by: Jazz Pharmaceuticals

Children, Adolescents and Their Providers: the Narcolepsy Assessment Partnership (CATNAPTM)

CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed.

The study has 16 active clinical sites and a virtual site that widens participation to anywhere in the United States. For more information about the study or to access the Online Patient Enrollment System, visit the CATNAP website: https://catnap.healthie.net/welcome or email catnap@pulseinfoframe.com. The Online Patient Enrollment System, CATNAP website, can also be found in the references section.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Not yet recruiting
        • Phoenix Children's Hospital
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • Not yet recruiting
        • University of Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Research Institute
    • California
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford University
      • San Diego, California, United States, 92093
        • Recruiting
        • University Of California San Diego
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Not yet recruiting
        • Children's National Medical Center
      • Washington, District of Columbia, United States, 20010
        • Not yet recruiting
        • Children's Research Institute
    • Florida
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Lurie Children's Hospital of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Not yet recruiting
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Not yet recruiting
        • Trinity Health-Michigan
      • Rochester, Michigan, United States, 55905
        • Not yet recruiting
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • St. Luke's Hospital
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Centre (UHCMC)
      • Columbus, Ohio, United States, 43205
        • Not yet recruiting
        • Nationwide Children's Hospital
      • Dublin, Ohio, United States, 43017
        • Recruiting
        • Ohio Sleep Medicine Institute
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital (Baylor College of Medicine)
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Hospital of The King's Daughters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Any child or adolescent with a physician-confirmed diagnosis of narcolepsy

Description

Inclusion Criteria:

  • Any child or adolescent with a physician-confirmed diagnosis of narcolepsy
  • Age less than 18 years
  • Willing to participate in the Registry and complete the informed consent form
  • Able to participate in English based registry

Exclusion Criteria:

  • Age 18 years or more
  • Fail to complete the informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improve Understanding of Natural History of Pediatric Narcolepsy
Time Frame: Up to 4 years
Up to 4 years
Characterize the Presentation, Identification, and Diagnosis of Narcolepsy in Pediatric Participants
Time Frame: Up to 4 years
Up to 4 years
Understand Treatment Practices and Outcomes Captured by Treatment Regimen and Rational for Changes
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvements in Quality of Life (QoL) as Measured by Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) Questionnaire
Time Frame: Up to 4 years
Up to 4 years
QoL - Pediatric Quality of Life Inventory (PedsQL)
Time Frame: Up to 4 years
Up to 4 years
Change in frequency of child ehavioral problems utilizing the Child Behavior Checklist (CBCL)
Time Frame: Up to 4 years
Up to 4 years
Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationship-Parent Proxy Short Form v2.0
Time Frame: Up to 4 years
Up to 4 years
Caregiver Work Limitations Questionnaire (C-WLQ)
Time Frame: Up to 4 years
Up to 4 years
Work Productivity and Activity Impairment (WPAI)
Time Frame: Up to 4 years
Up to 4 years
Change in Caregiver Well-being Measured by the Caregiver Well-Being Scale (Shortened)
Time Frame: Up to 4 years
Up to 4 years
Change in Level of Social Support using the Social Support Survey Instrument
Time Frame: Up to 4 years
Up to 4 years
Change in Pittsburgh Sleep Quality index (PSQI) scores
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2020

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HealhieCATNAPN.A.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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