Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Neurocognition in Congenital Central Hypoventilation Syndrome (CCHS)
NCT03568669 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER NIH Toolbox Cognition Battery
Study Locations (4)
California
- Children's Hospital Los Angeles — Los Angeles
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Washington
- Seattle Children's Hospital — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2016-01 |
| Est. Completion | 2035-12 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03568669
The ClinicalTrials.gov registry entry for NCT03568669 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debra Weese-Mayer, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Congenital Central Hypoventilation Syndrome appearing as the primary indexed condition, and to 1 intervention — of which NIH Toolbox Cognition Battery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03568669 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Illinois, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03568669 about?
NCT03568669 is a clinical study titled "Neurocognition in Congenital Central Hypoventilation Syndrome (CCHS)". 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 ...
What is the current status of trial NCT03568669?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2016-01. Estimated completion is 2035-12.
What conditions does trial NCT03568669 study?
This clinical trial studies the following conditions: Congenital Central Hypoventilation Syndrome, Congenital Central Hypoventilation, CCHS, CCHS With Hirschsprung Disease, CCHS With Neural Crest Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03568669?
The interventions under investigation include: NIH Toolbox Cognition Battery (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03568669?
This trial is sponsored by Debra Weese-Mayer, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03568669 being conducted?
This trial has 4 study locations across California, Illinois, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.