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Completed

NCT Number: NCT07098793

Cough Monitoring in COPD

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Redspiratory mMedicine, First Floor, Daisy Building, Castle Hill Hospital

Cottingham, East Yorkshiure, HU16 5JQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cough monitoring

Device

continuous recording of cough in patients sleeping area for 90-180 days

Primary outcomes

  1. Acute exacerbation of COPD alert system performance

    Time frame: 90-190 days

    the ratio of successful alerts of acute exacerbations of COPD to false positive alerts.

Secondary outcomes

  1. number of successfull alerts of Acute exacerbations of COPD

    Time frame: 90-180 days

    Total number of alerts of acute exacerbations of COPD identified by change in cough

  2. Number of False positive alerts of Acute Exacerbation of COPD

    Time frame: 90-180 days

    Total number of Acute exacerbation alerts detected by monitoring cough that didn't result in a acute exacerbation of COPD

  3. correlation cough counts with questionnaire data

    Time frame: 90-180 days

    correlate Hull airway reflux questionnaire scores, cough visual analgue scale with average cough counts

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • Philips Electronics Nederland B.V. acting through Philips CTO organization

Registry information

Official study title

Cough Monitoring in COPD:a Mixed Methods Observational Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

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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