NCT04899947

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

4 years

First QC Date

April 30, 2021

Last Update Submit

August 13, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Improve Understanding of Natural History of Pediatric Narcolepsy

    Up to 4 years

  • Characterize the Presentation, Identification, and Diagnosis of Narcolepsy in Pediatric Participants

    Up to 4 years

  • Understand Treatment Practices and Outcomes Captured by Treatment Regimen and Rational for Changes

    Up to 4 years

Secondary Outcomes (9)

  • Improvements in Quality of Life (QoL) as Measured by Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) Questionnaire

    Up to 4 years

  • QoL - Pediatric Quality of Life Inventory (PedsQL)

    Up to 4 years

  • Change in frequency of child ehavioral problems utilizing the Child Behavior Checklist (CBCL)

    Up to 4 years

  • Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationship-Parent Proxy Short Form v2.0

    Up to 4 years

  • Caregiver Work Limitations Questionnaire (C-WLQ)

    Up to 4 years

  • +4 more secondary outcomes

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

NOT YET RECRUITING

University of Arizona

Tucson, Arizona, 85719, United States

RECRUITING

University of Arkansas

Fayetteville, Arkansas, 72701, United States

NOT YET RECRUITING

Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States

RECRUITING

Stanford University

Redwood City, California, 94063, United States

RECRUITING

University of California San Diego

San Diego, California, 92093, United States

RECRUITING

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

NOT YET RECRUITING

Children's Research Institute

Washington D.C., District of Columbia, 20010, United States

NOT YET RECRUITING

University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21205, United States

NOT YET RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Trinity Health-Michigan

Grand Rapids, Michigan, 49503, United States

NOT YET RECRUITING

Mayo Clinic

Rochester, Michigan, 55905, United States

NOT YET RECRUITING

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

Northwell Health

Manhasset, New York, 11030, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

University Hospitals Cleveland Medical Centre (UHCMC)

Cleveland, Ohio, 44106, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

NOT YET RECRUITING

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

RECRUITING

Geisinger

Danville, Pennsylvania, 17822, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Texas Children's Hospital (Baylor College of Medicine)

Houston, Texas, 77030, United States

RECRUITING

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Director Clinical Trial Disclosure & Transparency

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 25, 2021

Study Start

October 10, 2020

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations