Cough monitoring to detect worsening COPD early
Official title: Continuous Cough Monitoring for Early Detection of COPD Exacerbations Using Hyfe
Run by Clinica Universidad de Navarra, Universidad de Navarra · NCT07212439 · Data updated 2026-11-12
This project will try continuous, automatic cough counting with a Hyfe wrist device and smartphone app to see if changes in cough frequency can warn adults with COPD about upcoming flare-ups.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra Academic / other |
| Locations | 3 sites (Pamplona, Navarre and 2 other locations) |
| Status | Recruiting |
| Started | October 29, 2025 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07212439 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with an established COPD diagnosis who can use a wrist device and smartphone app, including outpatients with at least one exacerbation in the past 12 months (and at least one month since the last exacerbation) and inpatients currently hospitalized for a moderate/severe exacerbation.
✕Probably not a fit
People who cannot consent or adhere to device use, those requiring invasive or non-invasive ventilation, or those living with someone with a chronic cough (excluded here) are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, multi-center observational cohort will enroll adults with COPD in both outpatient (history of recent exacerbations) and inpatient (currently hospitalized for moderate/severe exacerbation) groups. Participants will wear the Hyfe cough monitor (a wrist-like device paired to a smartphone app) that passively counts coughs without recording audio and will complete a weekly COPD Assessment Test (CAT). Treating clinicians will be blinded to the cough counts and CAT scores, and COPD exacerbations will be adjudicated using GOLD 2025 criteria as the ground-truth endpoint. The study aims to determine whether changes in objectively measured cough frequency provide a clinically useful lead time before clinician-diagnosed exacerbations.
Why it matters
Potential benefit: If successful, earlier detection of exacerbations could allow quicker treatment decisions and reduce severe worsening and hospitalizations.
How similar studies have gone: Preliminary and small-scale studies of automated cough monitoring have shown promising signals for respiratory worsening, but large, definitive validation for predicting COPD exacerbations remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Clinica San Miguel
Pamplona, Navarre, Spain Recruiting -
Clínica Universidad de Navarra, Universidad de Navarra
Pamplona, Navarre, Spain Recruiting -
Servicio Navarro de Salud
Pamplona, Navarre, Spain Recruiting
Study contacts
- Study coordinator: Carlos J. Chaccour, MD, PhD
- Email: cchaccour@unav.es
- Phone: +34 666 293 112
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.