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Recruiting NCT05989698

Validation of the C-mo System - Cough Monitoring

No phase Interventional Cough Asthma Chronic Obstructive Pulmonary Disease Gastro Esophageal Reflux

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: C-mo System.
Who it may be relevant to
Registry conditions: Cough, Asthma, Chronic Obstructive Pulmonary Disease, Gastro Esophageal Reflux. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 outcome measures

  • Cough detection (precision and recall) [Time frame: 24 hours]
  • Cough detection (F1-score) [Time frame: 24 hours]
  • Cough characterisation (precision, recall and global accuracy) [Time frame: 24 hours]
  • Cough characterisation (F1-score) [Time frame: 24 hours]
  • Cough characterisation (Matthews correlation coefficient) [Time frame: 24 hours]
  • Cough characterisation (Cohen's Kappa) [Time frame: 24 hours]
  • Wheezing detection (precision, recall, true negative rate, accuracy, and negative predictive value) [Time frame: 24 hours]
  • Wheezing detection (F1-score) [Time frame: 24 hours]
  • Cough frequency (Matthews correlation coefficient) [Time frame: 24 hours]
  • Cough frequency (Cohen's Kappa Index) [Time frame: 24 hours]
Secondary outcome measures (4)
  • Cough intensity [Time frame: 24 hours]
  • Cough patterns [Time frame: 24 hours]
  • Usability results [Time frame: 24 hours]
  • Cough perception vs. C-mo System analysis, in relation to gold standard (expert evaluation) [Time frame: 24 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Portugal · 8 centers
  • HPAV - Trofa Saúde Hospital de Alfena — Alfena
  • HFF - Hospital Professor Doutor Fernando Fonseca — Amadora
  • Lab3R - Laboratório de Investigação e Reabilitação Respiratória da Escola Superior de Saúd — Aveiro
  • CHUC - Centro Hospitalar e Universitário de Coimbra — Coimbra
  • HDE - Hospital Dona Estefânia — Lisbon
  • NMS Research - Laboratório de Exploração Funcional | Fisiopatologia — Lisbon
  • CHUSJ - Centro Hospitalar Universitário de São João — Porto
  • ICUFP - Instituto CUF Porto — Porto

Identifiers

NCT: NCT05989698 · C-mo_01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗