C-mo System
DevicePatients will use C-mo System for a period of 24h, to assess cough characteristics.
NCT Number: NCT05989698
The goal of this clinical study is to validate C-mo System's ability to automatically detect and characterise cough, in patients over 2 years old with cough as a key or refractory symptom.
The main questions it aims to answer are:
1. Can C-mo System detect cough events? (automatic cough detection) 2. Can C-mo System characterise cough events? (calculation of cough intensity, identification of cough type and presence of wheeze in detected coughs)
Participants will be asked to:
* Wear the C-mo Wearable device for 24 hours (1 day); * Complete a diary with relevant activities throughout the monitoring period; * Fill-out questionnaires related to coughing frequency and intensity, usability of the device, and impact of cough on quality of life.
Interested in participating?
Request Info2 year and older
All sexes
Interventional
Not applicable
HPAV - Trofa Saúde Hospital de Alfena, Alfena, Portugal
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will use C-mo System for a period of 24h, to assess cough characteristics.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically detect cough, using precision and recall (percentage - between 0% and 100%), higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically detect cough, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically characterise cough, using precision, recall, and global accuracy (percentage - between 0% and 100%), higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically characterise cough, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically characterise cough using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically characterise cough using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically detect wheezing in cough events, using precision, recall, true negative rate, accuracy, and negative predictive value (percentage - between 0% and 100%), higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically detect wheezing in cough events, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically assess cough frequency, based on the average "number of coughs per hour", using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically assess cough frequency, based on the average "number of coughs per hour", using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically assess cough type, based on the percentage of each cough type, using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically assess cough type, based on the percentage of each cough type, using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically assess wheeze in cough, based on the percentage of cough events in which wheezing was identified, using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
Time frame: 24 hours
Measure C-mo System's performance and ability to automatically assess wheeze in cough, based on the percentage of cough events in which wheezing was identified, using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
Time frame: 24 hours
Analyse the collected EMG signal to describe cough intensity, as percentage of maximum voluntary contraction (MVC).
Time frame: 24 hours
Describe cough patterns through the analysis of changes of cough characteristics (frequency, intensity, type and presence of wheeze) for each subject during their monitoring period, based on their post-monitoring questionnaire (if/how cough changes in relation to physical exercise, eating, resting, body position and time of day).
Time frame: 24 hours
Analyse the results from usability questionnaires regarding the C-mo wearable, calculating average scores for each of the evaluated parameters. A 5-point Likert scale will be used for the overall satisfaction score, in which a higher rating corresponds to a better outcome.
Time frame: 24 hours
Analyse the difference between the results obtained by the C-mo System and the results of the questionnaires filled out by the participants about their cough, comparing these obtained results to the gold standard. Differences between participants will also be analysed.
Statistical tests will be used to identify significant differences between groups (patient perception, C-mo System, and gold standard results).
Time frame: 24 hours
Compare each indicator (cough frequency, type, intensity, presence of wheeze, and cough patterns) amongst the diseases observed in the study's sample. This will be performed using multivariate analysis of variance (MANOVA).
Contact information is provided by the study sponsor or research team.
Diogo B Tecelão, MSc
CONTACT
Sara B Lobo
CONTACT
Cough Monitoring Medical Solutions
Industry
Acronym: C-mo_01
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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