C-mo System 1.0's Validation - Cough Monitoring (C-mo_01)

C-mo Medical Solutions

Status

Enrolling

Conditions

Asthma

Gastro Esophageal Reflux

Chronic Obstructive Pulmonary Disease

Cough

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

Cough is one of the most reported symptoms, especially associated with respiratory diseases. Additionally, cough contains extremely insightful information regarding the patient's health. It is a symptom full of physiopathological information, which can be extremely helpful in clinical practice. However, cough is not currently used as a clinical biomarker given that:

Cough is an extremely subjective symptom for patients (patients can't accurately describe and understand their cough's traits).
There is currently no tool available to evaluate cough objectively and thoroughly.

As such, there is an unmet medical need: solutions for objective cough monitoring and management.

C-mo System is a novel non-invasive medical device, which performs an objective monitoring of the patient's cough for long periods of time. The C-mo System consists of a wearable device (C-mo wearable) and a desktop software (C-mo Medical Platform). C-mo System characterises cough automatically through data collection and processing techniques (automatic classification), and its base outputs include:

Cough frequency (how many times the patient coughs)
Cough intensity (how strong cough's expiratory effort is)
Cough type (if the cough is dry, wet, or laryngeal)
Identification of patterns (associations between cough characteristics and specific events, namely the time of day, body position, physical exercising, and meals).

It is extremely important to validate C-mo System in a wide and diverse population, given the use of signal processing algorithms and artificial intelligence. C-mo System's base outputs will allow healthcare professionals to improve significantly the medical care associated with this symptom, namely:

Speed-up and improve the accuracy of the diagnosis of several medical conditions, especially respiratory diseases. C-mo System's ability to objectively monitor cough will allow healthcare professionals to make associations between specific cough patterns and specific medical conditions.
Optimize treatment prescription and monitor their effectiveness. C-mo System's objective assessment of cough will allow healthcare professionals to understand if a given therapy is working as intended.
Objectively monitor chronic disease progression. C-mo System's monitoring of cough will allow healthcare professionals to objectively assess the progression of the patient's cough.

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.