Recruiting

Validation of the C-mo System - Cough Monitoring

ClinicalTrials.gov IDNCT05989698

PhaseNA

Enrollment300

SponsorCough Monitoring Medical Solutions

Age2 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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.

Interventions

Device: C-mo System — Patients will use C-mo System for a period of 24h, to assess cough characteristics.

Primary outcomes

Cough detection (precision and recall) (24 hours)
Cough detection (F1-score) (24 hours)
Cough characterisation (precision, recall and global accuracy) (24 hours)
Cough characterisation (F1-score) (24 hours)
Cough characterisation (Matthews correlation coefficient) (24 hours)
Cough characterisation (Cohen's Kappa) (24 hours)
Wheezing detection (precision, recall, true negative rate, accuracy, and negative predictive value) (24 hours)
Wheezing detection (F1-score) (24 hours)

Eligibility information

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.

Study locations

HPAV - Trofa Saúde Hospital de Alfena, Alfena, Portugal
HFF - Hospital Professor Doutor Fernando Fonseca, Amadora, Portugal
Lab3R - Laboratório de Investigação e Reabilitação Respiratória da Escola Superior de Saúde da Universidade de Aveiro, Aveiro, Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal
HDE - Hospital Dona Estefânia, Lisbon, Portugal
NMS Research - Laboratório de Exploração Funcional | Fisiopatologia, Lisbon, Portugal
CHUSJ - Centro Hospitalar Universitário de São João, Porto, Portugal
ICUFP - Instituto CUF Porto, Porto, Portugal

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.