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. .
