Feasibility of Cough Monitoring in Children

Launched by UNIVERSITY OF COLORADO, DENVER · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method for monitoring coughs in children, specifically those with cystic fibrosis (CF). Cystic fibrosis is a condition that affects the lungs and makes it hard to clear mucus, leading to frequent lung infections and worsening lung function. Researchers want to see if a special device can track how often children cough while they sleep. This information could help doctors understand the severity of a child's condition and improve their care. The study will compare cough frequency between children with CF and healthy children, and look for any connections between cough frequency and lung health.

To participate, children must be between 1 and 18 years old and have a confirmed diagnosis of CF. They need to be stable and not using certain respiratory treatments. Healthy children in the same age range can also join the study, but they must not have any chronic respiratory or heart conditions. Participants will wear the cough monitoring device at home during the night, and their cough frequency will be recorded. This study will provide valuable insights that could lead to better monitoring and treatment options for children with CF in the future.

Gender

ALL

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)