Monitoring cough in children with cystic fibrosis
Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic
This study is testing a new artificial intelligence tool to see if it can accurately track how often children with cystic fibrosis cough, helping us understand their respiratory health better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06587126 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of using an artificial intelligence cough monitor to track cough frequency in children diagnosed with cystic fibrosis. The study will include children aged 1-18 years who are clinically stable and have a confirmed diagnosis of cystic fibrosis. By utilizing recent advancements in audio capture technology, the study seeks to automate cough detection, which has traditionally relied on subjective human reporting. The goal is to better understand cough patterns in this pediatric population and their correlation with respiratory health.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1-18 years with a confirmed diagnosis of cystic fibrosis who are clinically stable.
Not a fit: Patients who have underlying chronic respiratory or cardiac conditions, such as asthma or obstructive sleep apnea, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of cough in children with cystic fibrosis, potentially enhancing treatment outcomes.
How similar studies have performed: While the use of cough monitors has been explored in adults, this approach in the pediatric population is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Aurora, Colorado
- Children's Hospital of Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Lilah Melzer, DO — Children's Hospital Colorado, University of Colorado
- Study coordinator: Lilah Melzer, DO
- Email: lilah.melzer@childrenscolorado.org
- Phone: 7207772934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.