Clinical feasibility study utilizing multi-sensor devices with the goal of developing remote monitoring digital health solutions for patients with asthma or COPD

Abstract

Introduction: Using multi-sensor devices in large scale clinical trials may facilitate development of new digital health solutions for remote monitoring and care of patients. Choice of appropriate parameters and devices for use in such clinical trials poses significant technological and operational challenges. Aim: Conduct a technological, operational and clinical feasibility study to determine the most appropriate multi-sensor devices for use in large scale Asthma and COPD clinical trials Methods: Parameters of clinical relevance to monitor Asthma and COPD patients were shortlisted. Sensor devices were chosen based on required parameter coverage, regulatory status, scientific evidence and technological and operational feasibility. Sensor data was collected and analyzed from 29 patients (moderate to severe COPD or uncontrolled Asthma) in a 4-week observational clinical feasibility study. Results: Parameters with potential clinical relevance (inclusive of heart rate, oxygen saturation, respiratory rate, sleep, physical activity, lung function, FeNO, rescue medication use and environmental data) were assessed using the following devices: Philips Biosensor®, Biovotion®, ActiGraph®, GoSpiro®, NIOX VERO®, MDI Sensor (Propeller Health®) and Emfit® . Patient compliance, burden to patient, usability and data quality, varied between the sensor devices and between asthma and COPD patients. Conclusions: The key considerations for selection of digital sensors for large scale remote monitoring clinical trials are: type and severity of disease, clinically relevant parameters, burden to patient, usability and data-quality of devices.