Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT07098793
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2023-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cough Monitoring in COPD
Sponsor:
Hull University Teaching Hospitals NHS Trust
Organization:
Study Overview
Official Title:
Cough Monitoring in COPD:a Mixed Methods Observational Study
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: