Feasibility of Cough Monitoring in Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Curie Artificial Intelligence (AI) cough monitor

    Device

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Children with Cystic Fibrosis1 intervention
Group B: Healthy Controls1 intervention

Trial outcomes

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

Time frame
Through study completion, an average of 3 months

Secondary outcomes

1

Comparison of nighttime cough between participants with CF and healthy controls

Average cough seconds per hour per night over the study period

Time frame
Through study completion, an average of 3 months
2

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

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

Time frame
7 days

Other outcomes

Sponsors and contacts

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