NCT03568669 Neurocognition in Congenital Central Hypoventilation Syndrome (CCHS)
| NCT ID | NCT03568669 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ilya Khaytin |
| Condition | Congenital Central Hypoventilation Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2016-01 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2016-01 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * PHOX2B mutation-confirmed CCHS diagnosis * Speaks and reads English as a primary language Exclusion Criteria: * Unsuspected or unconfirmed CCHS * Does not speak or read English as a primary language
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03568669 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 85 Years, studying Congenital Central Hypoventilation Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03568669 currently recruiting?
Yes, NCT03568669 is actively recruiting participants. Contact the research team at crand@luriechildrens.org for enrollment information.
Where is the NCT03568669 trial being conducted?
This trial is being conducted at Los Angeles, United States, Chicago, United States, Philadelphia, United States, Seattle, United States.
Who is sponsoring the NCT03568669 clinical trial?
NCT03568669 is sponsored by Ilya Khaytin. The trial plans to enroll 1,000 participants.