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C-mo System 1.0's Validation - Cough Monitoring (C-mo_01)

Primary Purpose

Cough, Asthma, Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
C-mo System
Sponsored by
Cough Monitoring Medical Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cough focused on measuring Cough monitoring, Cough detection, Cough assessment, C-mo

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    C-mo System

    Arm Description

    Outcomes

    Primary Outcome Measures

    Cough detection (precision and recall)
    Measure C-mo System's performance and ability to automatically detect cough, using precision and recall (percentage - between 0% and 100%), higher scores mean a better outcome.
    Cough detection (F1-score)
    Measure C-mo System's performance and ability to automatically detect cough, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
    Cough characterisation (precision, recall and global accuracy)
    Measure C-mo System's performance and ability to automatically characterise cough, using precision, recall, and global accuracy (percentage - between 0% and 100%), higher scores mean a better outcome.
    Cough characterisation (F1-score)
    Measure C-mo System's performance and ability to automatically characterise cough, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
    Cough characterisation (Matthews correlation coefficient)
    Measure C-mo System's performance and ability to automatically characterise cough using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
    Cough characterisation (Cohen's Kappa)
    Measure C-mo System's performance and ability to automatically characterise cough using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
    Wheezing detection (precision, recall, true negative rate, accuracy, and negative predictive value)
    Measure C-mo System's performance and ability to automatically detect wheezing in cough events, using precision, recall, true negative rate, accuracy, and negative predictive value (percentage - between 0% and 100%), higher scores mean a better outcome.
    Wheezing detection (F1-score)
    Measure C-mo System's performance and ability to automatically detect wheezing in cough events, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
    Cough frequency (Matthews correlation coefficient)
    Measure C-mo System's performance and ability to automatically assess cough frequency, based on the average "number of coughs per hour", using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
    Cough frequency (Cohen's Kappa Index)
    Measure C-mo System's performance and ability to automatically assess cough frequency, based on the average "number of coughs per hour", using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
    Cough type percentage (Matthews correlation coefficient)
    Measure C-mo System's performance and ability to automatically assess cough type, based on the percentage of each cough type, using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
    Cough type percentage (Cohen's Kappa Index)
    Measure C-mo System's performance and ability to automatically assess cough type, based on the percentage of each cough type, using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
    Wheezing detection (Matthews correlation coefficient)
    Measure C-mo System's performance and ability to automatically assess wheeze in cough, based on the percentage of cough events in which wheezing was identified, using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
    Wheezing detection (Cohen's Kappa Index)
    Measure C-mo System's performance and ability to automatically assess wheeze in cough, based on the percentage of cough events in which wheezing was identified, using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.

    Secondary Outcome Measures

    Cough intensity
    Analyse the collected EMG signal to describe cough intensity, as percentage of maximum voluntary contraction (MVC).
    Cough patterns
    Describe cough patterns through the analysis of changes of cough characteristics (frequency, intensity, type and presence of wheeze) for each subject during their monitoring period, based on their post-monitoring questionnaire (if/how cough changes in relation to physical exercise, eating, resting, body position and time of day).
    Usability results
    Analyse the results from usability questionnaires regarding the C-mo wearable, calculating average scores for each of the evaluated parameters. A 5-point Likert scale will be used for the overall satisfaction score, in which a higher rating corresponds to a better outcome.
    Cough perception vs. C-mo System analysis, in relation to gold standard (expert evaluation)
    Analyse the difference between the results obtained by the C-mo System and the results of the questionnaires filled out by the participants about their cough, comparing these obtained results to the gold standard. Differences between participants will also be analysed. Statistical tests will be used to identify significant differences between groups (patient perception, C-mo System, and gold standard results).

    Full Information

    First Posted
    May 12, 2023
    Last Updated
    August 4, 2023
    Sponsor
    Cough Monitoring Medical Solutions
    Collaborators
    Universidade Nova de Lisboa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05989698
    Brief Title
    C-mo System 1.0's Validation - Cough Monitoring
    Acronym
    C-mo_01
    Official Title
    C-mo System 1.0's Validation - Cough Monitoring
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 11, 2023 (Anticipated)
    Primary Completion Date
    June 11, 2024 (Anticipated)
    Study Completion Date
    March 11, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cough Monitoring Medical Solutions
    Collaborators
    Universidade Nova de Lisboa

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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: Cough is an extremely subjective symptom for patients (patients can't accurately describe and understand their cough's traits). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cough, Asthma, Chronic Obstructive Pulmonary Disease, Gastro Esophageal Reflux, Idiopathic Pulmonary Fibrosis
    Keywords
    Cough monitoring, Cough detection, Cough assessment, C-mo

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    245 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    C-mo System
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    C-mo System
    Intervention Description
    Patients will use C-mo System for a period of 24h, to assess cough characteristics.
    Primary Outcome Measure Information:
    Title
    Cough detection (precision and recall)
    Description
    Measure C-mo System's performance and ability to automatically detect cough, using precision and recall (percentage - between 0% and 100%), higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Cough detection (F1-score)
    Description
    Measure C-mo System's performance and ability to automatically detect cough, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Cough characterisation (precision, recall and global accuracy)
    Description
    Measure C-mo System's performance and ability to automatically characterise cough, using precision, recall, and global accuracy (percentage - between 0% and 100%), higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Cough characterisation (F1-score)
    Description
    Measure C-mo System's performance and ability to automatically characterise cough, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Cough characterisation (Matthews correlation coefficient)
    Description
    Measure C-mo System's performance and ability to automatically characterise cough using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Cough characterisation (Cohen's Kappa)
    Description
    Measure C-mo System's performance and ability to automatically characterise cough using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Wheezing detection (precision, recall, true negative rate, accuracy, and negative predictive value)
    Description
    Measure C-mo System's performance and ability to automatically detect wheezing in cough events, using precision, recall, true negative rate, accuracy, and negative predictive value (percentage - between 0% and 100%), higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Wheezing detection (F1-score)
    Description
    Measure C-mo System's performance and ability to automatically detect wheezing in cough events, using the F1-score (value between 0 and 1), higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Cough frequency (Matthews correlation coefficient)
    Description
    Measure C-mo System's performance and ability to automatically assess cough frequency, based on the average "number of coughs per hour", using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Cough frequency (Cohen's Kappa Index)
    Description
    Measure C-mo System's performance and ability to automatically assess cough frequency, based on the average "number of coughs per hour", using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Cough type percentage (Matthews correlation coefficient)
    Description
    Measure C-mo System's performance and ability to automatically assess cough type, based on the percentage of each cough type, using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Cough type percentage (Cohen's Kappa Index)
    Description
    Measure C-mo System's performance and ability to automatically assess cough type, based on the percentage of each cough type, using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Wheezing detection (Matthews correlation coefficient)
    Description
    Measure C-mo System's performance and ability to automatically assess wheeze in cough, based on the percentage of cough events in which wheezing was identified, using Matthews correlation coefficient (MCC). The MCC value ranges from -1 to 1, and in this case it indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). A MCC value of -1 indicates total disagreement, 0 indicates that C-mo System's classification is no better than random guessing, and 1 represents a perfect classification (total agreement between C-mo System's output and the gold standard). Hence, higher scores mean a better outcome.
    Time Frame
    24 hours
    Title
    Wheezing detection (Cohen's Kappa Index)
    Description
    Measure C-mo System's performance and ability to automatically assess wheeze in cough, based on the percentage of cough events in which wheezing was identified, using Cohen's Kappa coefficient (κ). The κ value indicates the level of agreement between C-mo System's output and the result obtained from expert analysis (considered to be the gold standard in this study). It ranges from -1 (worst possible performance) to 1 (best possible performance). Hence, higher scores mean a better outcome.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Cough intensity
    Description
    Analyse the collected EMG signal to describe cough intensity, as percentage of maximum voluntary contraction (MVC).
    Time Frame
    24 hours
    Title
    Cough patterns
    Description
    Describe cough patterns through the analysis of changes of cough characteristics (frequency, intensity, type and presence of wheeze) for each subject during their monitoring period, based on their post-monitoring questionnaire (if/how cough changes in relation to physical exercise, eating, resting, body position and time of day).
    Time Frame
    24 hours
    Title
    Usability results
    Description
    Analyse the results from usability questionnaires regarding the C-mo wearable, calculating average scores for each of the evaluated parameters. A 5-point Likert scale will be used for the overall satisfaction score, in which a higher rating corresponds to a better outcome.
    Time Frame
    24 hours
    Title
    Cough perception vs. C-mo System analysis, in relation to gold standard (expert evaluation)
    Description
    Analyse the difference between the results obtained by the C-mo System and the results of the questionnaires filled out by the participants about their cough, comparing these obtained results to the gold standard. Differences between participants will also be analysed. Statistical tests will be used to identify significant differences between groups (patient perception, C-mo System, and gold standard results).
    Time Frame
    24 hours
    Other Pre-specified Outcome Measures:
    Title
    Relation between cough characteristics and target diseases
    Description
    Compare each indicator (cough frequency, type, intensity, presence of wheeze, and cough patterns) amongst the diseases observed in the study's sample. This will be performed using multivariate analysis of variance (MANOVA).
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diogo B Tecelão, MSc
    Phone
    +351 917 935 447
    Email
    diogo.tecelao@c-mo.solutions
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sara B Lobo
    Phone
    +351 967 889 091
    Email
    sara.lobo@c-mo.solutions
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nuno M Neuparth, PhD
    Organizational Affiliation
    NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    C-mo System 1.0's Validation - Cough Monitoring

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