Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
Location status: Recruiting
NCT Number: NCT06587126
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.
Interested in participating?
Request Info1 year–18 year
All sexes
Observational
Aurora, Colorado, 80045, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Children with Cystic Fibrosis
Exclusion criteria
Inclusion criteria
for Healthy Controls
Exclusion criteria
All patients are given nighttime cough monitors for home use for 3-4 months
Time frame: Through study completion, an average of 3 months
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
Average cough seconds per hour per night over the study period
Time frame: 7 days
Assess for changes in cough frequency before and after diagnosis of pulmonary exacerbation
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06066723
Cystic Fibrosis in Children, Pathologic Processes
Chapel Hill, North Carolina, United States
View Trial DetailsNCT06191640
Chronic Rhinosinusitis (Diagnosis), Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Aurora, Colorado, United States
View Trial DetailsNCT06984679
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Cystic Fibrosis
Izmir, Turkey (Türkiye)
View Trial DetailsNCT06617013
Cystic Fibrosis in Children, GERD in Children
Durham, North Carolina, United States
View Trial Details