Narcolepsy
Conditions
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.
Interventions
None listed
Sponsors
Jazz Pharmaceuticals
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Work Productivity and Activity Impairment (WPAI) | Up to 4 years |
| Improvements in Quality of Life (QoL) as Measured by Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) Questionnaire | Up to 4 years |
| Change in Level of Social Support using the Social Support Survey Instrument | Up to 4 years |
| Change in Pittsburgh Sleep Quality index (PSQI) scores | Up to 4 years |
| Change in Caregiver Well-being Measured by the Caregiver Well-Being Scale (Shortened) | 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 |
Countries
United States
Contacts
Primary ContactDirector Clinical Trial Disclosure & Transparency
Outcome results
None listed