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.
Patients aged 2 years or older;
Patients with symptoms/complaints of cough;
Signed Informed Consent (age ≥ 18 years), signed Informed Consent from the parents/legal representative and the patient (16 and 17 years), or signed Informed Assent and Consent (5 years ≤ age ≤ 15 years).
Presence of musculoskeletal (e.g., severe scoliosis), neurological (e.g., post stroke), cardiac (e.g., unstable angina), cognitive (e.g., dementia) changes, or other significant conditions that hinder the participants from collaborating in the collection of data.
Damaged/weakened skin at the C-mo wearable device's placement area (epigastric region).
Absence of Informed Consent and/or Assent, as applicable.
Single group
C-mo System
DevicePatients will use C-mo System for a period of 24h, to assess cough characteristics.
Cough detection (precision and recall)
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.
Cough detection (F1-score)
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.
Cough characterisation (precision, recall and global accuracy)
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.
Cough characterisation (F1-score)
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.
Cough intensity
Analyse the collected EMG signal to describe cough intensity, as percentage of maximum voluntary contraction (MVC).
Cough patterns
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).
Usability results
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.
Cough perception vs. C-mo System analysis, in relation to gold standard (expert evaluation)
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).
Relation between cough characteristics and target diseases
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).
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Cough Monitoring Medical Solutions
Lead sponsor
Universidade Nova de Lisboa
Collaborator
