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Feasibility of Cough Monitoring in Children with Cystic Fibrosis

This study is looking at how well a device called the Curie Artificial Intelligence (AI) cough monitor works to track coughs in children with cystic fibrosis (CF). CF is a disease that causes lung problems and frequent infections. While treatments like elexacaftor/tezacaftor/ivacaftor (ETI) can help, cough is still a common symptom. This study aims to see if the AI cough monitor can accurately measure coughs at home over 3-4 months. You may be able to join if you are a child with CF between 1 and 18 years old, have a confirmed CF diagnosis, and are currently stable. The study is currently recruiting participants.

Study design
This is an observational study planning to enroll 40 children with cystic fibrosis. It is not a randomized trial and does not involve a specific phase of drug development.
What's involved
If you join, you will use a nighttime cough monitor at home for 3-4 months.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured through study completion, which is an average of 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06587126

Feasibility of Cough Monitoring in Children

Recruiting
Not specifiedAges 1–18Observational
University of Colorado, Denver
~40 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:Curie Artificial Intelligence (AI) cough monitor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of using an in-home cough monitoring device
Measured over Through study completion, an average of 3 months

Conditions

Cystic Fibrosis in Children

Explore related trials

Cystic FibrosisHealthy

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

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

Who to contact

Lilah Melzer, DO
[email protected]
7207772934
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Ages 1-18

Exclusion

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)
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)

What this trial measures

  • Feasibility of using an in-home cough monitoring deviceThrough study completion, an average of 3 months

    Percent of nights over the study period during which 4 or more hours of analyzable data are collected over study period