A Microphone for Monitoring Coughs — CoughMonit  

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title: A Prospective Observational Pilot Study to Evaluate the Reliability and Usability of a Microphone Connected to a Medical Data Analysis Platform to Monitor Coughs in Hospitalized Patients Suffering From Respiratory Diseases

Status Not yet recruiting

Clinical Trial Summary

Aging of the population is dramatically increasing the number of hospitalized patients, with the consequent challenges of limited medical personnel and resources in hospitals. Wireless technologies that create highly connected healthcare environments are developed to help hospitals address these issues, once these technologies are perfectly integrated in the hospital environment with respect to IT infrastructure for big data storage. Such devices have proven remarkable efficiencies in monitoring patients with high patient safety, data accuracy and security, which are essential to provide high quality patient care, reduce health-related costs and optimize the management of high numbers of patients.

Cough is the most common condition that results in a visit to the physician. Often coughs are benign, but sometimes can be the sign of exacerbations of a chronic respiratory disease. Exacerbations are defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) document "as an acute event characterised by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication". It is assumed that, if coughs were remotely monitored, hospitals might be unburdened, patients would be empowered to self-manage their health, and that prevention of serious respiratory diseases might be facilitated, thus improving health outcomes. Unfortunately, remote monitoring for cough that rely on self-reporting is impractical, as patients do not record data very reliably. On the contrary, a microphone on the bedside table connected to a medical data analysis platform might monitor patients' cough exacerbations at night and alert the medical staff immediately.

Clinical Trial Description

The clinical study is designed as a prospective observational pilot study to evaluate the reliability of a microphone and data analysis platform to monitor coughs in hospitalized patients with respiratory diseases.

The study includes three phases:

1. Calibration phase: to determine the degree of coughs' homogeneity between patients. The control source of data will be a polygraph to record cough events and movements. Polygraphy is the conventional method currently used to analyse night coughing.

At the end of the calibration period, the data generated by the device will be analysed to determine if the coughs are homogeneous or heterogeneous, according to patient follow-up and polygragh outcomes. The degree of homogeneity will allow establishing the correct number of patients to be followed in the interventional phase (estimated 20 patients) and to set a threshold to define when there is an exacerbation.

2. Observational phase: to collect data in about 20 patients from sources, namely the microphone and the polygraph in the patient's room. Data will be collected in parallel by the two systems during two consecutive nights for each patient.

3. Data analysis phase: to correlate microphone and polygraph signals. These results will be reported in a format provided by the device supplier. Subsequently, specialized engineers will correlate the polygraph results with the microphone's signals. . ;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

• NCT number: NCT05007574
• Study type: Observational
• Source: Ligue Pulmonaire Neuchâteloise
• Status: Not yet recruiting
• Start date: October 1, 2021
• Completion date: February 1, 2022