Feasibility of Cough Monitoring in Children

Conditions

• Cystic Fibrosis in Children

Eligibility Criteria

Sex

ALL

Age

1 Year - 18 Years

Healthy Volunteers

Accepted

Interventions

• Curie Artificial Intelligence (AI) cough monitor — DEVICE
  All patients are given nighttime cough monitors for home use for 3-4 months

Study Details

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.

Key Dates

Start date

Feb 27, 2024

Status verified

Aug 2024

Primary completion

Dec 31, 2024

Completion

Dec 31, 2024

Study Design

Enrollment

40 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Feasibility of using an in-home cough monitoring device [ Time Frame: Through study completion, an average of 3 months ]

Central Contacts

• Lilah Melzer, DO
  7207772934
  [email protected]

Locations (1)

Find similar trials in Aurora, CO

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