Clinical trial NCT06587126: Feasibility of Cough Monitoring in Children
Official title: Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis in Children
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See inclusion and exclusion criteria for both groups above. Our aim to recruit 20 participants in each cohort.

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 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: 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)

Primary outcomes:
measure: Feasibility of using an in-home cough monitoring device
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Comparison of nighttime cough between participants with CF and healthy controls
timeFrame: Through study completion, an average of 3 months
measure: Comparison of nighttime cough in children with CF during clinician diagnosed pulmonary exacerbations
timeFrame: 7 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital of Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado, University of Colorado
name: Lilah Melzer, DO
role: PRINCIPAL_INVESTIGATOR
References: