Validation of the C-mo System - Cough Monitoring

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorCough Monitoring Medical Solutions

About this trial

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

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • C-mo System

Treatment groups

300 Participants
are divided into 1 treatment group

Sponsors and collaborators

Cough Monitoring Medical Solutions

Lead sponsor

Universidade Nova de Lisboa

Collaborator