An observational study in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Recruiting at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Observational
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.
This is a prospective, multi-center, observational cohort study designed to evaluate the accuracy of a continuous, passive acoustic monitoring system (Hyfe) for the early detection of COPD exacerbations. COPD exacerbations are a major driver of disease progression and healthcare utilization, but current detection methods rely on subjective patient-reported symptoms. Cough is a core symptom of COPD, and its objective quantification may provide an early warning signal for clinical worsening. This study aims to determine if changes in cough frequency, as measured by the Hyfe system, can predict an upcoming exacerbation with a clinically relevant lead time. The study will enroll two cohorts of patients with a COPD diagnosis: outpatients with a history of frequent exacerbations and inpatients hospitalized for a severe exacerbation. Participants will use the Hyfe Cough Monitor Suite to continuously track cough frequency and will complete the COPD Assessment Test (CAT) questionnaire weekly. To ensure an unbiased assessment, treating clinicians will be blinded to all study-collected data (both cough counts and CAT scores). The clinical diagnosis of a COPD exacerbation, as defined by GOLD 2025 criteria and made by the blinded clinician, will serve as the ground truth endpoint.
The study will enroll adult participants with a confirmed diagnosis of COPD. The population is composed of two distinct groups: inpatients who are currently hospitalized for a moderate/severe COPD exacerbation, and outpatients attending routine follow-up who are selected to enrich the sample with individuals who experience frequent exacerbations.
Exclusion criteria:
This cohort consists of patients with a confirmed COPD diagnosis who are currently hospitalized due to a severe COPD exacerbation.
This cohort includes outpatients with a COPD diagnosis who are being seen for routine follow-up. To be included, these patients must have a history of at least one exacerbation in the past 12 months.
Predictive accuracy of Hyfe cough monitoring for COPD exacerbations
(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
Time frame: Up to 1 year
Predictive accuracy: continuous vs. nighttime-only cough monitoring
Positive predictive value by time to exacerbation of continuous vs night-only monitoring
Time frame: Up to 1 year
Predictive accuracy: cough data vs. combined cough and symptom data
Positive predictive value by time to exacerbation of cough monitoring with and without the COPD Assessment Test (CAT) questionnaire vs the standard of care
Time frame: Up to 1 year
Estimated potential cost savings
Derived from hospitalization rate and 30-day readmission rates from standard of care vs the expected rates with earlier detection through cough monitoring should there be any
Time frame: Up to 1 year
Usability and acceptability of the Hyfe monitoring system
Usability will be measured by participant adherence, calculated as the percentage of time the monitor is worn or actively charging. Acceptability will be assessed using a self-reported user satisfaction survey administered to participants at the end of their follow-up period
Time frame: Up to 1 year
Plan to share: No — The study protocol does not outline a plan for sharing IPD with researchers external to the study team. The protocol's dissemination plan is focused on sharing aggregated study results in scientific meetings and through publication in peer-reviewed journals. While anonymized data will be shared with the study's co-investigators and the sponsor, there is no provision for making IPD available to other researchers.
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Pulmonary Disease, Chronic Obstructive→
Clinica Universidad de Navarra, Universidad de Navarra