NCT05989698 Validation of the C-mo System - Cough Monitoring
| NCT ID | NCT05989698 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cough Monitoring Medical Solutions |
| Condition | Cough |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-12-11 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-12-11 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Nuno M Neuparth, PhD
PRINCIPAL INVESTIGATOR
NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa
Frequently Asked Questions
Who can join the NCT05989698 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Cough. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05989698 currently recruiting?
Yes, NCT05989698 is actively recruiting participants. Contact the research team at diogo.tecelao@c-mo.solutions for enrollment information.
Where is the NCT05989698 trial being conducted?
This trial is being conducted at Alfena, Portugal, Amadora, Portugal, Aveiro, Portugal, Coimbra, Portugal and 4 additional locations.
Who is sponsoring the NCT05989698 clinical trial?
NCT05989698 is sponsored by Cough Monitoring Medical Solutions. The principal investigator is Nuno M Neuparth, PhD at NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa. The trial plans to enroll 300 participants.