Narcolepsy Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | October 1, 2024 |
| Est. primary completion date | October 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Johns Hopkins University | Baltimore | Maryland |
| United States | Boston Children's Hospital | Boston | Massachusetts |
| United States | St. Luke's Hospital | Chesterfield | Missouri |
| United States | Lurie Children's Hospital of Chicago | Chicago | Illinois |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | University Hospitals Cleveland Medical Centre (UHCMC) | Cleveland | Ohio |
| United States | Nationwide Children's Hospital | Columbus | Ohio |
| United States | Geisinger | Danville | Pennsylvania |
| United States | Ohio Sleep Medicine Institute | Dublin | Ohio |
| United States | University of Arkansas | Fayetteville | Arkansas |
| United States | Trinity Health-Michigan | Grand Rapids | Michigan |
| United States | Texas Children's Hospital (Baylor College of Medicine) | Houston | Texas |
| United States | Children's Mercy Hospital | Kansas City | Missouri |
| United States | Arkansas Children's Research Institute | Little Rock | Arkansas |
| United States | Northwell Health | Manhasset | New York |
| United States | Children's Hospital of the King's Daughters | Norfolk | Virginia |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Stanford University | Redwood City | California |
| United States | Mayo Clinic | Rochester | Michigan |
| United States | University of California San Diego | San Diego | California |
| United States | University of South Florida | Tampa | Florida |
| United States | University of Arizona | Tucson | Arizona |
| United States | Children's National Medical Center | Washington | District of Columbia |
| United States | Children's Research Institute | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Jazz Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improve Understanding of Natural History of Pediatric Narcolepsy | Up to 4 years | ||
| Primary | Characterize the Presentation, Identification, and Diagnosis of Narcolepsy in Pediatric Participants | Up to 4 years | ||
| Primary | Understand Treatment Practices and Outcomes Captured by Treatment Regimen and Rational for Changes | Up to 4 years | ||
| Secondary | Improvements in Quality of Life (QoL) as Measured by Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) Questionnaire | Up to 4 years | ||
| Secondary | QoL - Pediatric Quality of Life Inventory (PedsQL) | Up to 4 years | ||
| Secondary | Change in frequency of child ehavioral problems utilizing the Child Behavior Checklist (CBCL) | Up to 4 years | ||
| Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationship-Parent Proxy Short Form v2.0 | Up to 4 years | ||
| Secondary | Caregiver Work Limitations Questionnaire (C-WLQ) | Up to 4 years | ||
| Secondary | Work Productivity and Activity Impairment (WPAI) | Up to 4 years | ||
| Secondary | Change in Caregiver Well-being Measured by the Caregiver Well-Being Scale (Shortened) | Up to 4 years | ||
| Secondary | Change in Level of Social Support using the Social Support Survey Instrument | Up to 4 years | ||
| Secondary | Change in Pittsburgh Sleep Quality index (PSQI) scores | Up to 4 years |
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