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NCT Number: NCT06587126

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 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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Lilah Melzer, DO

CONTACT

[email protected]

7207772934

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Children with Cystic Fibrosis

  • Diagnosis of CF based on 2 known CFTR mutations and/or sweat chloride > 60 mmol/L
  • Ages 1-18 years of age
  • Clinically stable at the time of consent

Exclusion criteria

  • Use of nocturnal positive pressure or supplemental oxygen
  • Shared bedroom with sibling
  • Use of oral or IV antibiotics within the past 2 weeks except for chronic azithromycin use
  • Shared custody (i.e., the participant is splitting time between time households)

Inclusion criteria

for Healthy Controls

  • Ages 1-18

Exclusion criteria

  • Shared bedroom with sibling
  • Underlying chronic respiratory or cardiac conditions including chronic cough, CF, asthma, obstructive sleep apnea, or congenital heart disease or other condition felt by the investigator to cause chronic nighttime symptoms
  • Shared custody (i.e., the participant is splitting time between time households)

Treatment and study plan

Curie Artificial Intelligence (AI) cough monitor

Device

All patients are given nighttime cough monitors for home use for 3-4 months

Primary outcomes

  1. Feasibility of using an in-home cough monitoring device

    Time frame: Through study completion, an average of 3 months

    Percent of nights over the study period during which 4 or more hours of analyzable data are collected over study period

Secondary outcomes

  1. Comparison of nighttime cough between participants with CF and healthy controls

    Time frame: Through study completion, an average of 3 months

    Average cough seconds per hour per night over the study period

  2. Comparison of nighttime cough in children with CF during clinician diagnosed pulmonary exacerbations

    Time frame: 7 days

    Assess for changes in cough frequency before and after diagnosis of pulmonary exacerbation

Study contacts

Contact information is provided by the study sponsor or research team.

Lilah Melzer, DO

CONTACT

[email protected]

7207772934

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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