NCT Number: NCT07212439
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Clinica San Miguel, Pamplona, Navarre, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: Up to 1 year
Positive predictive value by time to exacerbation of continuous vs night-only monitoring
Time frame: Up to 1 year
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
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 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
Contact information is provided by the study sponsor or research team.
Carlos J. Chaccour, MD, PhD
CONTACT
Fhabián S. Carrión-Nessi, MD, MSc
CONTACT
Clinica Universidad de Navarra, Universidad de Navarra
Other
Continuous Cough Monitoring for Early Detection of COPD Exacerbations Using Hyfe
Acronym: Hyfe-EPOC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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