The clinical study is designed as a prospective observational pilot study to evaluate the reliability of a wireless bed sensor 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 an audio-video (AV) system consisting in a microphone and a polygraph to record cough events along with an infrared webcam to register patient's movements. 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 AV 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 both sources, namely the bed sensor and the AV system in the patient's hospital room. Data will be collected in parallel by the two systems during two consecutive nights for each patient.
3 Data analysis phase: to correlate bed sensor's signals with the AV recorded data. AV data as well computing will enable to determine the sensitivity and the selectivity of the device-generated signals.
