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C-mo System 1.0's Validation - Cough Monitoring

Study Purpose

Cough is one of the most reported symptoms, especially associated with respiratory diseases. Additionally, cough contains extremely insightful information regarding the patient's health. It is a symptom full of physiopathological information, which can be extremely helpful in clinical practice. However, cough is not currently used as a clinical biomarker given that: 1. Cough is an extremely subjective symptom for patients (patients can't accurately describe and understand their cough's traits). 2. There is currently no tool available to evaluate cough objectively and thoroughly. As such, there is an unmet medical need: solutions for objective cough monitoring and management. C-mo System is a novel non-invasive medical device, which performs an objective monitoring of the patient's cough for long periods of time. The C-mo System consists of a wearable device (C-mo wearable) and a desktop software (C-mo Medical Platform). C-mo System characterises cough automatically through data collection and processing techniques (automatic classification), and its base outputs include:

- Cough frequency (how many times the patient coughs) - Cough intensity (how strong cough's expiratory effort is) - Cough type (if the cough is dry, wet, or laryngeal) - Identification of patterns (associations between cough characteristics and specific events, namely the time of day, body position, physical exercising, and meals).

It is extremely important to validate C-mo System in a wide and diverse population, given the use of signal processing algorithms and artificial intelligence. C-mo System's base outputs will allow healthcare professionals to improve significantly the medical care associated with this symptom, namely:

- Speed-up and improve the accuracy of the diagnosis of several medical conditions, especially respiratory diseases.

C-mo System's ability to objectively monitor cough will allow healthcare professionals to make associations between specific cough patterns and specific medical conditions.

- Optimize treatment prescription and monitor their effectiveness.

C-mo System's objective assessment of cough will allow healthcare professionals to understand if a given therapy is working as intended.

- Objectively monitor chronic disease progression.

C-mo System's monitoring of cough will allow healthcare professionals to objectively assess the progression of the patient's cough.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years and Over
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05989698
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cough Monitoring Medical Solutions
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nuno M Neuparth, PhD
Principal Investigator Affiliation	NOVA Medical School \| Faculdade de Ciências Médicas da Universidade Nova de Lisboa
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	Portugal
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cough, Asthma, Chronic Obstructive Pulmonary Disease, Gastro Esophageal Reflux, Idiopathic Pulmonary Fibrosis

Arms & Interventions

Arms

Experimental: C-mo System

Interventions

Device: - C-mo System

Patients will use C-mo System for a period of 24h, to assess cough characteristics.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.