Monitoring Coughs for the Early Detection of Worsening COPD

Официальное название

Continuous Cough Monitoring for Early Detection of COPD Exacerbations Using Hyfe

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Predictive accuracy of Hyfe cough monitoring for COPD exacerbations [Срок оценки: Up to 1 year]

Вторичные конечные точки (4)

• Predictive accuracy: continuous vs. nighttime-only cough monitoring [Срок оценки: Up to 1 year]
• Predictive accuracy: cough data vs. combined cough and symptom data [Срок оценки: Up to 1 year]
• Estimated potential cost savings [Срок оценки: Up to 1 year]
• Usability and acceptability of the Hyfe monitoring system [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 3 центра

• Clinica San Miguel — Pamplona
• Clínica Universidad de Navarra, Universidad de Navarra — Pamplona
• Servicio Navarro de Salud — Pamplona

Публикации

• 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. PMID 22281834
• 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. PMID 29529879
• 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. PMID 21565915
• 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. PMID 30237306
• 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. PMID 35586452
• 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. PMID 35651361
• 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. PMID 39085518
• 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. PMID 39762316

Идентификаторы

NCT: NCT07212439 · Hyfe-EPOC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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