Feasibility of Cough Monitoring in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Curie Artificial Intelligence (AI) cough monitor.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis in Children. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic
Overview
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
All patients are given nighttime cough monitors for home use for 3-4 months
Primary outcome measures
- Feasibility of using an in-home cough monitoring device [Time frame: Through study completion, an average of 3 months]
Secondary outcome measures (2)
- Comparison of nighttime cough between participants with CF and healthy controls [Time frame: Through study completion, an average of 3 months]
- Comparison of nighttime cough in children with CF during clinician diagnosed pulmonary exacerbations [Time frame: 7 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's Hospital of Colorado — Aurora
Identifiers
NCT: NCT06587126 · 23-0382