Cystic Fibrosis in ChildrenNCT06587126
Feasibility of Cough Monitoring in Children
An observational study of Cystic Fibrosis in Children, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- Curie Artificial Intelligence (AI) cough monitor
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: See inclusion and exclusion criteria for both groups above. Our aim to recruit 20 participants in each cohort.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Colorado
Aurora, Colorado, 80045
Lilah Melzer, DO, 7207772934, lilah.melzer@childrenscolorado.org
About this study
Official title: Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic
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.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- Curie Artificial Intelligence (AI) cough monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curie Artificial Intelligence (AI) cough monitorDevice
All patients are given nighttime cough monitors for home use for 3-4 months
| Study group | Role | What they receive |
|---|---|---|
| Children with Cystic Fibrosis | Childrens ages 1-18 with a diagnosis of CF based on 2 known cystic fibrosis transmembrane conductance regulator (CFTR) mutations and/or sweat chloride >60 mmol/L, thought to be clinically stable at the time of study consent. Receives: Device: Curie Artificial Intelligence (AI) cough monitor | |
| Healthy Controls | Children ages 1-18 with no underlying respiratory of cardiac conditions including chronic cough, CF, asthma, obstructive sleep apnea, or congenital heart disease thought to cause chronic nighttime symptoms. Receives: Device: Curie Artificial Intelligence (AI) cough monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using an in-home cough monitoring device
Percent of nights over the study period during which 4 or more hours of analyzable data are collected over study period
Measured: Through study completion, an average of 3 months
Secondary outcomes (2)
Comparison of nighttime cough between participants with CF and healthy controls
Average cough seconds per hour per night over the study period
Measured: Through study completion, an average of 3 months
Comparison of nighttime cough in children with CF during clinician diagnosed pulmonary exacerbations
Assess for changes in cough frequency before and after diagnosis of pulmonary exacerbation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Feb 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lilah Melzer, DO, Principal investigator, Children's Hospital Colorado, University of Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587126
- Sponsor's protocol ID
- 23-0382
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic
- ClinicalTrials.gov ID
- NCT06587126
- Acronym / sponsor ID
- 23-0382
- Conditions
- Cystic Fibrosis in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Cystic Fibrosis | – | Device: Curie Artificial Intelligence (AI) cough monitorChildrens ages 1-18 with a diagnosis of CF based on 2 known cystic fibrosis transmembrane conductance regulator (CFTR) mutations and/or sweat chloride >60 mmol/L, thought to be clinically stable at the time of study consent. |
| Healthy Controls | – | Device: Curie Artificial Intelligence (AI) cough monitorChildren ages 1-18 with no underlying respiratory of cardiac conditions including chronic cough, CF, asthma, obstructive sleep apnea, or congenital heart disease thought to cause chronic nighttime symptoms. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- See inclusion and exclusion criteria for both groups above. Our aim to recruit 20 participants in each cohort.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curie Artificial Intelligence (AI) cough monitorAll patients are given nighttime cough monitors for home use for 3-4 months | Device | Children with Cystic Fibrosis, Healthy Controls |
Primary outcome
Feasibility of using an in-home cough monitoring device
Time frame: Through 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
2 secondary outcomes
Comparison of nighttime cough between participants with CF and healthy controls
Time frame: Through study completion, an average of 3 months
Comparison of nighttime cough in children with CF during clinician diagnosed pulmonary exacerbations
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilah Melzer, DO principal investigator
Children's Hospital Colorado, University of Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis in Children, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lilah Melzer, DO (7207772934, lilah.melzer@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using an in-home cough monitoring device (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.