NCT05989698

Validation of the C-mo System - Cough Monitoring

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Cough Monitoring Medical Solutions · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cough
• Asthma
• Chronic Obstructive Pulmonary Disease
• Gastro Esophageal Reflux
• Idiopathic Pulmonary Fibrosis
• Cough Frequency
• Cough Severity
• Coughing

Interventions

Type	Name	Description
DEVICE	C-mo System	Patients will use C-mo System for a period of 24h, to assess cough characteristics.

Timeline

• Start date: 2023-12-11
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2023-08-14
• Last updated: 2026-04-08

Locations

8 sites across 1 country: Portugal