Validation of the C-mo System - Cough Monitoring
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 ch
| Condition(s) | Cough, Asthma, Chronic Obstructive Pulmonary Disease, Gastro Esophageal Reflux, Idiopathic Pulmonary Fibrosis, Cough Frequency, Cough Severity, Coughing |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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). Exclusion Criteria: * 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. |
| Ages | 2 Years |
| Sex | All |
| Lead sponsor | Cough Monitoring Medical Solutions |
| Locations | Alfena, Portugal; Amadora, Portugal; Aveiro, Portugal; Coimbra, Portugal; Lisbon, Portugal; Lisbon, Portugal (+2 more sites) |
| Start date | 2023-12-11 |
| NCT ID | NCT05989698 |
| Official listing | https://clinicaltrials.gov/study/NCT05989698 |