Feasibility of Cough Monitoring in Children

NCT ID: NCT06587126

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2024-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Curie Artificial Intelligence (AI) cough monitor

Intervention Type: DEVICE

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

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.

Curie Artificial Intelligence (AI) cough monitor

Intervention Type: DEVICE

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

Interventions

Curie Artificial Intelligence (AI) cough monitor

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Ages 1-18

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)

• 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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lilah Melzer, DO

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado, University of Colorado

Locations

Children's Hospital of Colorado

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lilah Melzer, DO

Role: CONTACT

lilah.melzer@childrenscolorado.org

7207772934

Facility Contacts

Lilah Melzer, DO

Role: primary

lilah.melzer@childrenscolorado.org

7207772934

Other Identifiers

23-0382

Identifier Type: -

Identifier Source: org_study_id