Validation of the C-mo System - Cough Monitoring (C-mo_01)

C-mo Medical Solutions

Status

Enrolling

Conditions

Asthma

Cough Severity

Coughing

Gastro Esophageal Reflux

Chronic Obstructive Pulmonary Disease

Cough

Cough Frequency

Idiopathic Pulmonary Fibrosis

Treatments

Device: C-mo System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05989698

C-mo_01

Details and patient eligibility

About

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:

Can C-mo System detect cough events? (automatic cough detection)
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.

Enrollment

245 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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.