Validation of the C-mo System - Cough Monitoring

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT05989698

Run by

Cough Monitoring Medical Solutions

People needed

300

Starts

2023-12-11

Expected to finish

2026-09-01

Last updated by the study team

2026-04-08

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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