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NCT06587126 · ClinicalTrials.gov registry record

Feasibility of Cough Monitoring in Children

A clinical trial of Cystic Fibrosis in Children, sponsored by University of Colorado, Denver.

Recruiting
Registry status
40
Enrollment target
1
Study location

NCT06587126 is a study of Cystic Fibrosis in Children that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 40 participants, below the 83-participant average among 6 other Cystic Fibrosis in Children trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06587126, a study of Cystic Fibrosis in Children, is actively recruiting participants, sponsored by University of Colorado, Denver.

RECRUITING
Registry status
40 participants
Enrollment target
1
Study location

Study Summary

Cystic fibrosis (CF) is a disease characterized by chronic airway infection and impaired mucociliary clearance, which predisposes those affected to recurrent pulmonary exacerbations (PEx) and progressive decline in lung function. Treatment with elexacaftor/tezacaftor/ivacaftor (ETI) results in decreases in patient-reported cough and PEx. Despite this, increased cough remains the most common symptom associated with acute PEx and worsening lung disease. Cough frequency was historically difficult to measure due to reliance on human input. Recent advances in audio capture and signal processing have made automated cough detection possible. As a result there's been a surge in development of portable cough monitors, as cough is increasingly recognized as a measurable parameter of respiratory disease. The majority of cough monitors have been designed for use in adults, and little is known about the practicality of collecting cough data in the pediatric population. In this study investigators aim to assess the feasibility of using an in-home device to capture nighttime cough frequency in children with and without CF. Investigators plan to compare nighttime cough frequency between children with and without CF and, among children with CF, and determine the association between cough frequency and baseline lung function. Additionally, investigators aim to evaluate the changes in nighttime cough frequency in relationship to respiratory symptom scores surrounding clinician diagnosed pulmonary exacerbations. This study will provide important preliminary data needed for a larger study assessing the utility of home cough monitoring for clinical care and for use of cough as a clinical outcome measure in research studies.

Interventions

  • DEVICE Curie Artificial Intelligence (AI) cough monitor

Study Locations (1)

Colorado

  • Children's Hospital of Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-02-27
Est. Completion 2024-12

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT06587126

The ClinicalTrials.gov registry entry for NCT06587126 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 6 other Cystic Fibrosis in Children trials with a reported enrollment target (52% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis in Children appearing as the primary indexed condition, and to 1 intervention - of which Curie Artificial Intelligence (AI) cough monitor is the first listed.

NCT06587126 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT06587126 about?

NCT06587126 is a clinical study titled "Feasibility of Cough Monitoring in Children". Cystic fibrosis (CF) is a disease characterized by chronic airway infection and impaired mucociliary clearance, which predisposes those affected to recurrent pulmonary exacerbations (PEx) and progressive decline in lung function. Treatment with elexacaftor/tezacaftor/ivacaftor (ETI) results in decre...

What is the current status of trial NCT06587126?

This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2024-02-27. Estimated completion is 2024-12.

What conditions does trial NCT06587126 study?

This clinical trial studies the following conditions: Cystic Fibrosis in Children.

What interventions are being tested in trial NCT06587126?

The interventions under investigation include: Curie Artificial Intelligence (AI) cough monitor (DEVICE).

Who is sponsoring clinical trial NCT06587126?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06587126 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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