C-mo System 1.0's Validation - Cough Monitoring

Last updated: February 10, 2025
Sponsor: Cough Monitoring Medical Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Asthma

Treatment

C-mo System

Clinical Study ID

NCT05989698
C-mo_01
  • Ages > 2
  • All Genders

Study Summary

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:

  1. Cough is an extremely subjective symptom for patients (patients can't accurately describe and understand their cough's traits).

  2. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 2 years or older;

  • Patients with symptoms/complaints of cough;

  • Signed Informed Consent (age ≥ 18 years), signed Informed Consent from theparents/legal representative and the patient (16 and 17 years), or signed InformedAssent and Consent (5 years ≤ age ≤ 15 years).

Exclusion

Exclusion Criteria:

  • Presence of musculoskeletal (e.g., severe scoliosis), neurological (e.g., poststroke), cardiac (e.g., unstable angina), cognitive (e.g., dementia) changes, orother significant conditions that hinder the participants from collaborating in thecollection of data.

  • Damaged/weakened skin at the C-mo wearable device's placement area (epigastricregion).

  • Absence of Informed Consent and/or Assent, as applicable.

Study Design

Total Participants: 245
Treatment Group(s): 1
Primary Treatment: C-mo System
Phase:
Study Start date:
December 11, 2023
Estimated Completion Date:
June 11, 2026

Connect with a study center

  • HFF - Hospital Professor Doutor Fernando Fonseca

    Amadora,
    Portugal

    Active - Recruiting

  • NMS Research - Laboratório de Exploração Funcional | Fisiopatologia

    Lisboa,
    Portugal

    Active - Recruiting

  • CHUSJ - Centro Hospitalar Universitário de São João

    Porto,
    Portugal

    Active - Recruiting

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