Validation of the C-mo System - Cough Monitoring

NCT ID: NCT05989698

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-11

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cough Asthma Chronic Obstructive Pulmonary Disease Gastro Esophageal Reflux Idiopathic Pulmonary Fibrosis Cough Frequency Cough Severity Coughing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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C-mo System

Group Type EXPERIMENTAL

C-mo System

Intervention Type DEVICE

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

Interventions

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C-mo System

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Nova de Lisboa

OTHER

Sponsor Role collaborator

Cough Monitoring Medical Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nuno M Neuparth, PhD

Role: PRINCIPAL_INVESTIGATOR

NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa

Locations

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HPAV - Trofa Saúde Hospital de Alfena

Alfena, , Portugal

Site Status RECRUITING

HFF - Hospital Professor Doutor Fernando Fonseca

Amadora, , Portugal

Site Status RECRUITING

Lab3R - Laboratório de Investigação e Reabilitação Respiratória da Escola Superior de Saúde da Universidade de Aveiro

Aveiro, , Portugal

Site Status RECRUITING

CHUC - Centro Hospitalar e Universitário de Coimbra

Coimbra, , Portugal

Site Status RECRUITING

HDE - Hospital Dona Estefânia

Lisbon, , Portugal

Site Status RECRUITING

NMS Research - Laboratório de Exploração Funcional | Fisiopatologia

Lisbon, , Portugal

Site Status RECRUITING

CHUSJ - Centro Hospitalar Universitário de São João

Porto, , Portugal

Site Status RECRUITING

ICUFP - Instituto CUF Porto

Porto, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Diogo B Tecelão, MSc

Role: CONTACT

+351 917 935 447

Sara B Lobo

Role: CONTACT

+351 967 889 091

Facility Contacts

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Daniela Rodrigues

Role: primary

José Pedro Boléo-Tomé

Role: primary

Ana Oliveira

Role: primary

Pedro Gonçalo Ferreira

Role: primary

Raquel Lopes de Bragança

Role: primary

Nuno Neuparth

Role: primary

David Araújo

Role: primary

João Carlos Winck

Role: primary

Other Identifiers

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C-mo_01

Identifier Type: -

Identifier Source: org_study_id

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