RecruitingNCT03568669

Neurocognition in Congenital Central Hypoventilation Syndrome (CCHS)

Neurocognitive Outcome as a Metric for Evaluating Therapeutic Intervention and Treatment Mechanisms in Congenital Central Hypoventilation Syndrome (CCHS): A Multi-Site Study Using The NIH Toolbox


Sponsor

Debra Weese-Mayer

Enrollment

1,000 participants

Start Date

Jan 1, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

Congenital central hypoventilation syndrome (CCHS) is a rare disorder of autonomic and respiratory regulation that frequently alters oxygen delivery to the brain. In CCHS, neurocognitive function has been of great concern because of the potential for repeated hypoxemia and hypercarbia in activities of daily living in addition to hypoventilation with related hypoxemia and hypercarbia during sleep. As the world's leading referral center for CCHS, the Center for Autonomic Medicine in Pediatrics (CAMP) is engaged in ongoing research to identify factors that impact neurocognitive performance in patients with CCHS in order to optimize clinical management and improve long term neurocognitive outcomes. The purpose of this IRB-approved research study is to implement the NIH Toolbox as a standard measurement of cognitive health in patients with CCHS. Further, the study aims to determine how intrinsic and extrinsic disease factors such as age at diagnosis, PHOX2B mutation type and genotype, and nature of past and present artificial respiratory intervention affect the NIH Toolbox Cognitive scores of individuals with CCHS. Eligible participants will complete a 45-minute NIH Toolbox assessment and parents (or adult participants) will complete an associated, 15-minute Research Electronic Data Capture (REDCap) questionnaire.


Eligibility

Min Age: 3 YearsMax Age: 85 Years

Inclusion Criteria2

  • PHOX2B mutation-confirmed CCHS diagnosis
  • Speaks and reads English as a primary language

Exclusion Criteria2

  • Unsuspected or unconfirmed CCHS
  • Does not speak or read English as a primary language

Interventions

OTHERNIH Toolbox Cognition Battery

An app-based cognitive assessment of executive function, attention, memory, and language that takes approximately 45 minutes to complete on an iPad


Locations(4)

Children's Hospital Los Angeles

Los Angeles, California, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Seattle Children's Hospital

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03568669


Related Trials