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NCT03568669 · ClinicalTrials.gov registry record

Neurocognition in Congenital Central Hypoventilation Syndrome (CCHS)

A clinical trial of Congenital Central Hypoventilation Syndrome and Congenital Central Hypoventilation, sponsored by Debra Weese-Mayer.

Recruiting
Registry status
1,000
Enrollment target
4
Study locations

NCT03568669 is a study of Congenital Central Hypoventilation Syndrome and Congenital Central Hypoventilation that is actively recruiting participants, run by Debra Weese-Mayer. The registered enrollment target is 1,000 participants. The trial reports 4 study locations across 4 states.

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The verdict

NCT03568669, a study of Congenital Central Hypoventilation Syndrome and Congenital Central Hypoventilation, is actively recruiting participants, sponsored by Debra Weese-Mayer.

RECRUITING
Registry status
1,000 participants
Enrollment target
4
Study locations

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.

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

FieldValue
Enrollment Target 1,000 participants
Start Date 2016-01
Est. Completion 2035-12

Sponsor

Debra Weese-Mayer

3 total trials

What the Registry Record Tells You About NCT03568669

The ClinicalTrials.gov registry entry for NCT03568669 describes a study currently listed as recruiting, categorized as an unspecified phase. 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.

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.

NCT03568669 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Illinois, Pennsylvania.

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.

What interventions are being tested in trial NCT03568669?

The interventions under investigation include: NIH Toolbox Cognition Battery (OTHER).

Who is sponsoring clinical trial NCT03568669?

This trial is sponsored by Debra Weese-Mayer, which has 3 total clinical trials registered on ClinicalTrials.gov.

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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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