Monitoring Coughs for the Early Detection of Worsening COPD
Recruiting · NCT07212439 · Observational (researchers observe without assigning treatment) · Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
View the official record on ClinicalTrials.gov →What this trial is about
This study is for adults with COPD. Flare-ups of COPD, also known as exacerbations, can be serious and lead to hospital stays. The purpose of this research is to see if continuously and automatically monitoring a person's coughs can help predict these flare-ups early, before they become severe. Participants will use the Hyfe cough monitoring system, which includes a watch-like device worn on the wrist and a smartphone application. The system privately counts the number of coughs without recording any audio. Participants will also answer a short, weekly questionnaire about their COPD symptoms. This is an observational study, which means it will not change the regular medical care a participant receives. The participants and their care providers will not see the cough counts. The doctor will continue to manage their COPD as usual.
Who can take part
Inclusion criteria
- Must be 18 years of age or older.
- Must have an existing diagnosis of COPD.
- For the inpatient cohort, participants must be currently assessed as having a moderate/severe exacerbation.
- For the outpatient cohort, participants must have had at least one exacerbation of any severity in the last 12 months.
- For the outpatient cohort, at least one month must have passed since the last exacerbation.
Exclusion criteria
- Individuals who are unable to provide informed consent.
- Individuals who are unable to adhere to study procedures.
- For the inpatient cohort, individuals requiring invasive or non-invasive ventilation.
- Individuals who live with a person who has a chronic cough.
Where it is running
3 locations listed.
- Clinica San Miguel - Pamplona, Navarre, Spain
- Clínica Universidad de Navarra, Universidad de Navarra - Pamplona, Navarre, Spain
- Servicio Navarro de Salud - Pamplona, Navarre, Spain