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Neurocognition in Congenital Central Hypoventilation Syndrome (CCHS)

NCT03568669 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-08-09

No results posted yet for this study

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.

Conditions

  • Congenital Central Hypoventilation Syndrome
  • Congenital Central Hypoventilation
  • CCHS
  • CCHS With Hirschsprung Disease
  • CCHS With Neural Crest Tumor
  • CCHS With Neuroblastoma

Interventions

OTHER

NIH 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

Sponsors & Collaborators

Eligibility

Min Age
3 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2030-12-31
Completion
2035-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03568669 on ClinicalTrials.gov