Chronic Obstructive Pulmonary Disease (COPD)Hyfe-EPOCNCT07212439
Monitoring Coughs for the Early Detection of Worsening COPD
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Clinica Universidad de Navarra, Universidad de Navarra at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 50 participants
- Where
- 3 sitesSpain
- Study dates
- 29 Oct 2025to Sep 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Clinica San Miguel
Pamplona, Navarre, 31006
Dra. Astrid Alvarado, MD, 948 296 000, astrid.alvarado@clinicasanmiguel.es
- Recruiting
Clínica Universidad de Navarra, Universidad de Navarra
Pamplona, Navarre, 31008
Juan P. De Torres, MD, +34 948 296 500, jpdetorres@unav.es
- Recruiting
Servicio Navarro de Salud
Pamplona, Navarre, 31008
Francisco J. Bartolomé, MD, +34 609 44 95 78, fjbr@medena.es
About this study
Official title: Continuous Cough Monitoring for Early Detection of COPD Exacerbations Using Hyfe
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.
Read the detailed description
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.
- Keywords
- COPD, COPD Exacerbation, Cough, Cough Monitoring, Hyfe, Early Detection, Wearable Device, Artificial Intelligence, Observational Study
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatients | This cohort consists of patients with a confirmed COPD diagnosis who are currently hospitalized due to a severe COPD exacerbation. | |
| Outpatients | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year
Secondary outcomes (4)
Predictive accuracy: continuous vs. nighttime-only cough monitoring
Positive predictive value by time to exacerbation of continuous vs night-only monitoring
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start29 Oct 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Hyfe Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212439
- Sponsor's protocol ID
- Hyfe-EPOC
- Acronym
- Hyfe-EPOC
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Mackay AJ, Donaldson GC, Patel AR, Jones PW, Hurst JR, Wedzicha JA. Usefulness of the Chronic Obstructive Pulmonary Disease Assessment Test to evaluate severity of COPD exacerbations. Am J Respir Crit Care Med. 2012 Jun 1;185(11):1218-24. doi: 10.1164/rccm.201110-1843OC. Epub 2012 Jan 26.
PubMed 22281834Folch Ayora A, Macia-Soler L, Orts-Cortes MI, Hernandez C, Seijas-Babot N. Comparative analysis of the psychometric parameters of two quality-of-life questionnaires, the SGRQ and CAT, in the assessment of patients with COPD exacerbations during hospitalization: A multicenter study. Chron Respir Dis. 2018 Nov;15(4):374-383. doi: 10.1177/1479972318761645. Epub 2018 Mar 12.
PubMed 29529879Jones PW, Brusselle G, Dal Negro RW, Ferrer M, Kardos P, Levy ML, Perez T, Soler Cataluna JJ, van der Molen T, Adamek L, Banik N. Properties of the COPD assessment test in a cross-sectional European study. Eur Respir J. 2011 Jul;38(1):29-35. doi: 10.1183/09031936.00177210. Epub 2011 May 12.
PubMed 21565915Kim V, Aaron SD. What is a COPD exacerbation? Current definitions, pitfalls, challenges and opportunities for improvement. Eur Respir J. 2018 Nov 15;52(5):1801261. doi: 10.1183/13993003.01261-2018. Print 2018 Nov.
PubMed 30237306Gabaldon-Figueira JC, Keen E, Rudd M, Orrilo V, Blavia I, Chaccour J, Galvosas M, Small P, Grandjean Lapierre S, Chaccour C. Longitudinal passive cough monitoring and its implications for detecting changes in clinical status. ERJ Open Res. 2022 May 16;8(2):00001-2022. doi: 10.1183/23120541.00001-2022. eCollection 2022 Apr.
PubMed 35586452Gabaldon-Figueira JC, Keen E, Gimenez G, Orrillo V, Blavia I, Dore DH, Armendariz N, Chaccour J, Fernandez-Montero A, Bartolome J, Umashankar N, Small P, Grandjean Lapierre S, Chaccour C. Acoustic surveillance of cough for detecting respiratory disease using artificial intelligence. ERJ Open Res. 2022 May 30;8(2):00053-2022. doi: 10.1183/23120541.00053-2022. eCollection 2022 Apr.
PubMed 35651361Chung KF, Chaccour C, Jover L, Galvosas M, Song WJ, Rudd M, Small P. Longitudinal Cough Frequency Monitoring in Persistent Coughers: Daily Variability and Predictability. Lung. 2024 Oct;202(5):561-568. doi: 10.1007/s00408-024-00734-x. Epub 2024 Jul 31.
PubMed 39085518Chaccour C, Sanchez-Olivieri I, Siegel S, Megson G, Winthrop KL, Botella JB, de-Torres JP, Jover L, Brew J, Kafentzis G, Galvosas M, Rudd M, Small P. Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study. Sci Rep. 2025 Jan 6;15(1):880. doi: 10.1038/s41598-025-85341-3.
PubMed 39762316den Brinker AC, Thackray-Nocera S, Crooks MG, Morice AH. Improved Precision of COPD Exacerbation Detection in Night-Time Cough Monitoring. J Pers Med. 2025 Aug 2;15(8):349. doi: 10.3390/jpm15080349.
PubMed 40863411Morice AH, den Brinker AC, Crooks M, Thackray-Nocera S, Ouweltjes O, Rietman R. Can Passive Cough Monitoring Predict COPD Exacerbations? COPD. 2025 Apr 4;22(1):2487909. doi: 10.1080/15412555.2025.2487909. Epub 2025 Apr 14.
PubMed 40223505
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Cough Monitoring for Early Detection of COPD Exacerbations Using Hyfe
- ClinicalTrials.gov ID
- NCT07212439
- Acronym / sponsor ID
- Hyfe-EPOC / Hyfe-EPOC
- Keywords
- COPD, COPD Exacerbation, Cough, Cough Monitoring, Hyfe, Early Detection, Wearable Device, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Hyfe Inc
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatients | – | –This cohort consists of patients with a confirmed COPD diagnosis who are currently hospitalized due to a severe COPD exacerbation. |
| Outpatients | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive accuracy of Hyfe cough monitoring for COPD exacerbations
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
4 secondary outcomes
Predictive accuracy: continuous vs. nighttime-only cough monitoring
Time frame: Up to 1 year
Predictive accuracy: cough data vs. combined cough and symptom data
Time frame: Up to 1 year
Estimated potential cost savings
Time frame: Up to 1 year
Usability and acceptability of the Hyfe monitoring system
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Background: PubMed 22281834Mackay AJ, Donaldson GC, Patel AR, Jones PW, Hurst JR, Wedzicha JA. Usefulness of the Chronic Obstructive Pulmonary Disease Assessment Test to evaluate severity of COPD exacerbations. Am J Respir Crit Care Med. 2012 Jun 1;185(11):1218-24. doi: 10.1164/rccm.201110-1843OC. Epub 2012 Jan 26.
- Background: PubMed 29529879Folch Ayora A, Macia-Soler L, Orts-Cortes MI, Hernandez C, Seijas-Babot N. Comparative analysis of the psychometric parameters of two quality-of-life questionnaires, the SGRQ and CAT, in the assessment of patients with COPD exacerbations during hospitalization: A multicenter study. Chron Respir Dis. 2018 Nov;15(4):374-383. doi: 10.1177/1479972318761645. Epub 2018 Mar 12.
- Background: PubMed 21565915Jones PW, Brusselle G, Dal Negro RW, Ferrer M, Kardos P, Levy ML, Perez T, Soler Cataluna JJ, van der Molen T, Adamek L, Banik N. Properties of the COPD assessment test in a cross-sectional European study. Eur Respir J. 2011 Jul;38(1):29-35. doi: 10.1183/09031936.00177210. Epub 2011 May 12.
- Background: PubMed 30237306Kim V, Aaron SD. What is a COPD exacerbation? Current definitions, pitfalls, challenges and opportunities for improvement. Eur Respir J. 2018 Nov 15;52(5):1801261. doi: 10.1183/13993003.01261-2018. Print 2018 Nov.
- Background: PubMed 35586452Gabaldon-Figueira JC, Keen E, Rudd M, Orrilo V, Blavia I, Chaccour J, Galvosas M, Small P, Grandjean Lapierre S, Chaccour C. Longitudinal passive cough monitoring and its implications for detecting changes in clinical status. ERJ Open Res. 2022 May 16;8(2):00001-2022. doi: 10.1183/23120541.00001-2022. eCollection 2022 Apr.
- Background: PubMed 35651361Gabaldon-Figueira JC, Keen E, Gimenez G, Orrillo V, Blavia I, Dore DH, Armendariz N, Chaccour J, Fernandez-Montero A, Bartolome J, Umashankar N, Small P, Grandjean Lapierre S, Chaccour C. Acoustic surveillance of cough for detecting respiratory disease using artificial intelligence. ERJ Open Res. 2022 May 30;8(2):00053-2022. doi: 10.1183/23120541.00053-2022. eCollection 2022 Apr.
- Background: PubMed 39085518Chung KF, Chaccour C, Jover L, Galvosas M, Song WJ, Rudd M, Small P. Longitudinal Cough Frequency Monitoring in Persistent Coughers: Daily Variability and Predictability. Lung. 2024 Oct;202(5):561-568. doi: 10.1007/s00408-024-00734-x. Epub 2024 Jul 31.
- Background: PubMed 39762316Chaccour C, Sanchez-Olivieri I, Siegel S, Megson G, Winthrop KL, Botella JB, de-Torres JP, Jover L, Brew J, Kafentzis G, Galvosas M, Rudd M, Small P. Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study. Sci Rep. 2025 Jan 6;15(1):880. doi: 10.1038/s41598-025-85341-3.
- Background: PubMed 40863411den Brinker AC, Thackray-Nocera S, Crooks MG, Morice AH. Improved Precision of COPD Exacerbation Detection in Night-Time Cough Monitoring. J Pers Med. 2025 Aug 2;15(8):349. doi: 10.3390/jpm15080349.
- Background: PubMed 40223505Morice AH, den Brinker AC, Crooks M, Thackray-Nocera S, Ouweltjes O, Rietman R. Can Passive Cough Monitoring Predict COPD Exacerbations? COPD. 2025 Apr 4;22(1):2487909. doi: 10.1080/15412555.2025.2487909. Epub 2025 Apr 14.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Clinica Universidad de Navarra, Universidad de Navarra at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos J. Chaccour, MD, PhD (+34 666 293 112, cchaccour@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive accuracy of Hyfe cough monitoring for COPD exacerbations (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07212439, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.