RecruitingNot ApplicableNCT05989698

Validation of the C-mo System - Cough Monitoring

Sponsor

Cough Monitoring Medical Solutions

Enrollment

245 participants

Start Date

Dec 11, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 2 Years

Inclusion Criteria3

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 Criteria3

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.