RECRUITING

Feasibility of Cough Monitoring in Children

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic

Quick Facts

Study Start:2024-02-27
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06587126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Shared bedroom with sibling
  2. * 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
  3. * Shared custody (i.e., the participant is splitting time between time households)

Contacts and Locations

Study Contact

Lilah Melzer, DO
CONTACT
7207772934
lilah.melzer@childrenscolorado.org

Principal Investigator

Lilah Melzer, DO
PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado, University of Colorado

Study Locations (Sites)

Children's Hospital of Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Lilah Melzer, DO, PRINCIPAL_INVESTIGATOR, Children's Hospital Colorado, University of Colorado

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-27
Study Completion Date2024-12

Study Record Updates

Study Start Date2024-02-27
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Cystic Fibrosis in Children