Cough Monitoring in COPD

Completed

• Conditions: Cough; COPD; COPD Exacerbation

• Registration Number: NCT07098793
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Brief Summary

This is an observational study designed to learn about symptoms of cough and how changes in cough may be associated with the beginning of a COPD exacerbation (acute worsening of symptoms.

The Investigators are looking to recruit patients diagnosed with COPD who have had two or more exacerbations of their disease within the last year requiring treatment with antibiotics or corticosteroids.

The main question aimed to be answered is whether the cough monitor can detect changes in a patient's clinical condition.

Patients will be screened for participation in the study and a medical history will be taken alongside details of current medications, height, weight, vital signs as well and smoking status.

The patients will be asked to complete 3 questionnaires and the cough monitor will be installed in the room within their home where they sleep.

Patients will be asked to complete a daily diary for 90 to a maximum of 180 days and leave the monitor recording cough throughout this time.

Detailed Description

COPD is associated with disabling, progressive symptoms with episodes of rapid worsening termed acute exacerbations (AECOPD). It poses a significant global health challenge with AECOPD often resulting in the use of unscheduled care services including hospital attendance and admission. In addition to trying to prevent AECOPD, strategies have been developed to identify clinical deterioration early prompting intervention in the community with the aim of preventing unscheduled care service utilization.

Telemonitoring refers to the use of technology to monitor patients' clinical condition in their own homes. One of the proposed benefits of telemonitoring is the early detection of clinical deterioration. At present, COPD telemonitoring relies on daily symptom reporting and monitoring of basic physiological data including heart rate and pulse oximetry. However, current strategies lack specificity resulting in difficulty identifying true exacerbations from normal day to day variation.

Cough and sputum production are reported by 60-80% of COPD patients, are increased at the time of exacerbation, and are associated with accelerated lung function decline, frequent exacerbations, and earlier mortality. It has previously been demonstrated that change in cough frequency at the time of exacerbation can be detected using a cough monitor that utilizes cough classifier software to analyse ambient sound. In the context of telemonitoring, this has the potential to facilitate the early detection of clinical change using an objective measure that does not require patient effort.

Remote monitoring of COPD patients in their own homes aims to detect clinical deterioration early prompting intervention in the community with the aim of preventing utilization of unscheduled care services. Current systems do not succeed in reaching this target . A pilot study of remote cough monitoring has demonstrated that cough frequency was significantly increased during COPD exacerbation and trends in cough frequency can be detected using remote microphones and automated cough counting software. In a follow-up study, a cough-based alert system has been constructed showing promising performance. This prospective evaluation will validate the constructed system in a further COPD patient cohort.

Study Timeline

• Study Start: 2022-05-18
• Study First Submitted: 2023-09-05
• Primary Completion: 2024-06-19
• Study Completion: 2024-10-10
• Status Verified: 2025-03
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• • Clinical diagnosis of COPD using GOLD criteria.

  • 2 or more moderate and/or severe exacerbations of COPD in the previous year*.
  • Clinical stability (i.e. absence of exacerbation requiring oral corticosteroids and/or antibiotics) for at least 4 weeks prior to enrollment.
  • Current or ex-smoker with ≥10 pack-year smoking history
  • Provision of informed consent

Exclusion Criteria

• • Children < age of 18

  • Failure to provide consent
  • Other significant comorbid medical or psychological condition that is deemed by the principal investigator to affect cough frequency or the subject's ability to comply with monitoring procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute exacerbation of COPD alert system performance	90-190 days	the ratio of successful alerts of acute exacerbations of COPD to false positive alerts.

Secondary Outcome Measures

Name	Time	Method
number of successfull alerts of Acute exacerbations of COPD	90-180 days	Total number of alerts of acute exacerbations of COPD identified by change in cough
Number of False positive alerts of Acute Exacerbation of COPD	90-180 days	Total number of Acute exacerbation alerts detected by monitoring cough that didn't result in a acute exacerbation of COPD
correlation cough counts with questionnaire data	90-180 days	correlate Hull airway reflux questionnaire scores, cough visual analgue scale with average cough counts

Trial Locations

Locations (1)

Redspiratory mMedicine, First Floor, Daisy Building, Castle Hill Hospital; 🇬🇧 Cottingham, East Yorkshiure, United Kingdom