Validation of the C-mo System - Cough Monitoring

Sponsor
Cough Monitoring Medical Solutions
Study ID
NCT05989698
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 14, 2023
Start date
Dec 11, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: C-mo System

Primary Outcome Measure

Cough detection (precision and recall) [ Time Frame: 24 hours ]

Central Contacts

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