Clinical trial NCT04899947: Child and Adolescent Registry for Participants With Narcolepsy
Official title: Children, Adolescents and Their Providers: the Narcolepsy Assessment Partnership (CATNAPTM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Narcolepsy
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-05-25
Enrollment: 500
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any child or adolescent with a physician-confirmed diagnosis of narcolepsy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improve Understanding of Natural History of Pediatric Narcolepsy
timeFrame: Up to 4 years
measure: Characterize the Presentation, Identification, and Diagnosis of Narcolepsy in Pediatric Participants
timeFrame: Up to 4 years
measure: Understand Treatment Practices and Outcomes Captured by Treatment Regimen and Rational for Changes
timeFrame: Up to 4 years
Secondary outcomes:
measure: Improvements in Quality of Life (QoL) as Measured by Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) Questionnaire
timeFrame: Up to 4 years
measure: QoL - Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Up to 4 years
measure: Change in frequency of child ehavioral problems utilizing the Child Behavior Checklist (CBCL)
timeFrame: Up to 4 years
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationship-Parent Proxy Short Form v2.0
timeFrame: Up to 4 years
measure: Caregiver Work Limitations Questionnaire (C-WLQ)
timeFrame: Up to 4 years
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: Up to 4 years
measure: Change in Caregiver Well-being Measured by the Caregiver Well-Being Scale (Shortened)
timeFrame: Up to 4 years
measure: Change in Level of Social Support using the Social Support Survey Instrument
timeFrame: Up to 4 years
measure: Change in Pittsburgh Sleep Quality index (PSQI) scores
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Research Institute
state: Arkansas
city: Redwood City
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Children's Research Institute
state: District of Columbia
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Trinity Health-Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Michigan
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Centre (UHCMC)
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital (Baylor College of Medicine)
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
Study officials:
References: