Feasibility of Cough Monitoring in Children

NCT06587126 | Recruiting FDA Device

• 1 other identifier: 23-0382
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis in Children

Outcome Measures

Primary Outcomes (1)

• Feasibility of using an in-home cough monitoring device

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

  Through study completion, an average of 3 months

Secondary Outcomes (2)

• Comparison of nighttime cough between participants with CF and healthy controls

  Through study completion, an average of 3 months

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

  7 days

Study Arms (2)

Children with Cystic Fibrosis

Childrens ages 1-18 with a diagnosis of CF based on 2 known cystic fibrosis transmembrane conductance regulator (CFTR) mutations and/or sweat chloride \>60 mmol/L, thought to be clinically stable at the time of study consent.

Device: Curie Artificial Intelligence (AI) cough monitor

Healthy Controls

Children ages 1-18 with no underlying respiratory of cardiac conditions including chronic cough, CF, asthma, obstructive sleep apnea, or congenital heart disease thought to cause chronic nighttime symptoms.

Device: Curie Artificial Intelligence (AI) cough monitor

Interventions

Curie Artificial Intelligence (AI) cough monitor DEVICE

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

Children with Cystic Fibrosis; Healthy Controls

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

See inclusion and exclusion criteria for both groups above. Our aim to recruit 20 participants in each cohort.

You may qualify if:

• 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

You may not qualify if:

• 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)
• Ages 1-18
• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Study Officials

• Lilah Melzer, DO

  Children's Hospital Colorado, University of Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilah Melzer, DO

CONTACT

7207772934; lilah.melzer@childrenscolorado.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: September 19, 2024
• Study Start: February 27, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

US (1)