Child and Adolescent Registry for Participants With Narcolepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Narcolepsy. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Children, Adolescents and Their Providers: the Narcolepsy Assessment Partnership (CATNAPTM)
Overview
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.
Primary outcome measures
- Improve Understanding of Natural History of Pediatric Narcolepsy [Time frame: Up to 4 years]
- Characterize the Presentation, Identification, and Diagnosis of Narcolepsy in Pediatric Participants [Time frame: Up to 4 years]
- Understand Treatment Practices and Outcomes Captured by Treatment Regimen and Rational for Changes [Time frame: Up to 4 years]
Secondary outcome measures (9)
- 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]
- QoL - Pediatric Quality of Life Inventory (PedsQL) [Time frame: Up to 4 years]
- Change in frequency of child ehavioral problems utilizing the Child Behavior Checklist (CBCL) [Time frame: 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]
- Caregiver Work Limitations Questionnaire (C-WLQ) [Time frame: Up to 4 years]
- Work Productivity and Activity Impairment (WPAI) [Time frame: Up to 4 years]
- Change in Caregiver Well-being Measured by the Caregiver Well-Being Scale (Shortened) [Time frame: Up to 4 years]
- Change in Level of Social Support using the Social Support Survey Instrument [Time frame: Up to 4 years]
- Change in Pittsburgh Sleep Quality index (PSQI) scores [Time frame: Up to 4 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 25 centers
- Phoenix Children's Hospital — Phoenix
- University of Arizona — Tucson
- University of Arkansas — Fayetteville
- Arkansas Children's Research Institute — Little Rock
- Stanford University — Redwood City
- University of California San Diego — San Diego
- Children's National Medical Center — Washington D.C.
- Children's Research Institute — Washington D.C.
- … and 17 more centers
Identifiers
NCT: NCT04899947 · HealhieCATNAPN.A.