Monitoring Coughs for the Early Detection of Worsening COPD

NCT ID: NCT07212439

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-29
• Study Completion Date: 2026-09-30

Brief 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.

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Inpatients

This cohort consists of patients with a confirmed COPD diagnosis who are currently hospitalized due to a severe COPD exacerbation.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hyfe Inc

OTHER

Sponsor Role: collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinica San Miguel

Pamplona, Navarre, Spain

Site Status: RECRUITING

Clínica Universidad de Navarra, Universidad de Navarra

Pamplona, Navarre, Spain

Site Status: RECRUITING

Servicio Navarro de Salud

Pamplona, Navarre, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Carlos J. Chaccour, MD, PhD

Role: CONTACT

cchaccour@unav.es

+34 666 293 112

Fhabián S. Carrión-Nessi, MD, MSc

Role: CONTACT

fhabiancarrion@gmail.com

+58 424 958 80 43

Facility Contacts

Dra. Astrid Alvarado, MD

Role: primary

astrid.alvarado@clinicasanmiguel.es

948 296 000

Juan P. De Torres, MD

Role: primary

jpdetorres@unav.es

+34 948 296 500

Francisco J. Bartolomé, MD

Role: primary

fjbr@medena.es

+34 609 44 95 78

References

Morice 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.

Reference Type: BACKGROUND

PMID: 40223505 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22281834 (View on PubMed)

Folch 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.

Reference Type: BACKGROUND

PMID: 29529879 (View on PubMed)

Jones 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.

Reference Type: BACKGROUND

PMID: 21565915 (View on PubMed)

Kim 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.

Reference Type: BACKGROUND

PMID: 30237306 (View on PubMed)

Gabaldon-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.

Reference Type: BACKGROUND

PMID: 35586452 (View on PubMed)

Gabaldon-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.

Reference Type: BACKGROUND

PMID: 35651361 (View on PubMed)

Chung 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.

Reference Type: BACKGROUND

PMID: 39085518 (View on PubMed)

Chaccour 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.

Reference Type: BACKGROUND

PMID: 39762316 (View on PubMed)

den 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.

Reference Type: BACKGROUND

PMID: 40863411 (View on PubMed)

Other Identifiers

Hyfe-EPOC

Identifier Type: -

Identifier Source: org_study_id