Validation of a cough monitoring system
Validation of the C-mo System - Cough Monitoring
This study is testing a new wearable device that tracks coughs in patients aged 2 and older to see if it can help doctors better understand and manage respiratory issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Cough Monitoring Medical Solutions Industry-sponsored |
| Locations | 8 sites (Alfena and 7 other locations) |
| Trial ID | NCT05989698 on ClinicalTrials.gov |
What this trial studies
This study evaluates the C-mo System, a novel non-invasive medical device designed for objective monitoring of cough in patients. The system includes a wearable device that collects data on cough characteristics and a desktop software platform for analysis. By providing a thorough assessment of cough, the C-mo System aims to address the subjective nature of cough reporting and improve clinical management of respiratory conditions. The study will involve patients aged 2 years and older who experience cough symptoms.
Who should consider this trial
Good fit: Ideal candidates include patients aged 2 years or older who exhibit symptoms of cough.
Not a fit: Patients with significant musculoskeletal, neurological, cardiac, or cognitive conditions that impede data collection may not benefit from this study.
Why it matters
Potential benefit: If successful, this system could lead to more accurate diagnosis and management of respiratory diseases by providing objective cough data.
How similar studies have performed: While the approach of objective cough monitoring is innovative, similar studies have not been widely reported, indicating this may be a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Alfena and 7 other locations
- HPAV - Trofa Saúde Hospital de Alfena — Alfena, Portugal (Recruiting)
- HFF - Hospital Professor Doutor Fernando Fonseca — Amadora, Portugal (Recruiting)
- Lab3R - Laboratório de Investigação e Reabilitação Respiratória da Escola Superior de Saúde da Universidade de Aveiro — Aveiro, Portugal (Completed)
- CHUC - Centro Hospitalar e Universitário de Coimbra — Coimbra, Portugal (Recruiting)
- HDE - Hospital Dona Estefânia — Lisbon, Portugal (Recruiting)
- NMS Research - Laboratório de Exploração Funcional | Fisiopatologia — Lisbon, Portugal (Recruiting)
- CHUSJ - Centro Hospitalar Universitário de São João — Porto, Portugal (Recruiting)
- ICUFP - Instituto CUF Porto — Porto, Portugal (Recruiting)
Study contacts
- Principal investigator: Nuno M Neuparth, PhD — NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa
- Study coordinator: Diogo B Tecelão, MSc
- Email: diogo.tecelao@c-mo.solutions
- Phone: +351 917 935 447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.