Validation of the C-mo System - Cough Monitoring

Last updated: September 3, 2025
Sponsor: Cough Monitoring Medical Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Cystic Fibrosis

Treatment

C-mo System

Clinical Study ID

NCT05989698
C-mo_01
  • Ages > 2
  • All Genders

Study 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 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:
September 30, 2026

Connect with a study center

  • HPAV - Trofa Saúde Hospital de Alfena

    Alfena 2743095,
    Portugal

    Active - Recruiting

  • HFF - Hospital Professor Doutor Fernando Fonseca

    Amadora,
    Portugal

    Site Not Available

  • HFF - Hospital Professor Doutor Fernando Fonseca

    Amadora 2271772,
    Portugal

    Active - Recruiting

  • Lab3R - Laboratório de Investigação e Reabilitação Respiratória da Escola Superior de Saúde da Universidade de Aveiro

    Aveiro 2742611,
    Portugal

    Active - Recruiting

  • CHUC - Centro Hospitalar e Universitário de Coimbra

    Coimbra 2740637,
    Portugal

    Active - Recruiting

  • NMS Research - Laboratório de Exploração Funcional | Fisiopatologia

    Lisboa,
    Portugal

    Site Not Available

  • HDE - Hospital Dona Estefânia

    Lisbon 2267057,
    Portugal

    Active - Recruiting

  • NMS Research - Laboratório de Exploração Funcional | Fisiopatologia

    Lisbon 2267057,
    Portugal

    Active - Recruiting

  • CHUSJ - Centro Hospitalar Universitário de São João

    Porto,
    Portugal

    Site Not Available

  • CHUSJ - Centro Hospitalar Universitário de São João

    Porto 2735943,
    Portugal

    Active - Recruiting

  • ICUFP - Instituto CUF Porto

    Porto 2735943,
    Portugal

    Active - Recruiting

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