Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587126
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Feasibility of Cough Monitoring in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 elexacaftortezacaftorivacaftor 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 theres 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None