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Clinical Trials in Spain / NCT07212439
Recruiting Observational

Monitoring Coughs for the Early Detection of Worsening COPD

NCT07212439 · tracked via the Priya Life Science Spain tracker
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Phase
Observational
Started
2025-10-29
Last updated
2026-01-02

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Predictive accuracy of Hyfe cough monitoring for COPD exacerbations — Up to 1 year
    (a) Positive predictive value (PPV) by time to exacerbation vs standard of care (SoC) (b) False positive and false negative rates by time to exacerbation vs SoC

Trial sites (3)

FacilityCityRegionStatus
Clinica San Miguel Pamplona Navarre Recruiting
Clínica Universidad de Navarra, Universidad de Navarra Pamplona Navarre Recruiting
Servicio Navarro de Salud Pamplona Navarre Recruiting

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Other trials for the same condition

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease Active, not recruiting
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006) Recruiting
A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07212439 on ClinicalTrials.gov ↗ ← All trials in Spain