Actively Recruiting
Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic Fibrosis
Led by University of Colorado, Denver · Updated on 2024-09-19
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the feasibility of using a home nighttime cough monitoring device to measure cough frequency in children aged 1 to 18 years, both with and without cystic fibrosis (CF). CF is a condition marked by chronic lung infections and mucus buildup, leading to frequent lung flare-ups and declining lung function. While certain treatments reduce cough and flare-ups, cough remains a common symptom, and new technology allows for automated, more accurate cough detection especially in children where data is limited. Participants will be given a Curie Artificial Intelligence (AI) cough monitor device to use at home during the night for about 3 to 4 months. The study includes two groups: children with CF who are clinically stable and children without respiratory or heart conditions. The device will capture cough frequency, which researchers will compare between groups and analyze alongside lung function and symptom changes during pulmonary exacerbations. Children and their families will use the cough monitor at home, and researchers will collect data over approximately three months. The main focus is on measuring how practical it is to gather cough data this way. Additional assessments will compare cough frequency between children with CF and healthy controls, and observe cough changes around lung flare-ups. This study will help inform future research on using cough monitoring as a clinical tool in CF care.
CONDITIONS
Brief Title
Feasibility of Cough Monitoring in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 18 years
- Diagnosis of cystic fibrosis based on 2 known CFTR mutations and/or sweat chloride greater than 60 mmol/L
- Clinically stable at the time of consent
- Healthy children aged 1 to 18 years without chronic respiratory or cardiac conditions
You will not qualify if you...
- Use of nocturnal positive pressure or supplemental oxygen
- Sharing a bedroom with a sibling
- Use of oral or IV antibiotics within the past 2 weeks except for chronic azithromycin use
- Shared custody with time split between households
- Underlying chronic respiratory or cardiac conditions including chronic cough, CF, asthma, obstructive sleep apnea, congenital heart disease, or other conditions causing chronic nighttime symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 4 months
Participants use a nighttime cough monitoring device at home to record cough patterns.
Device used nightly at home over the monitoring period
Trial Site Locations
Total: 1 location
1
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
L
Lilah Melzer, DO
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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