Efficient Data Capture for Clinical Trials of Consumer Devices

Problem

Consumer health technologies, including wearable technologies, have facilitated efficient data collection of patient health metrics in realistic, non-clinical environments. These technologies open the door to a wide array of potential studies linking health to socioeconomic, demographic, geographic, and psychological factors. However, due to the lack of standardized data formats and collection protocols across these devices, it is difficult to collect patient data remotely, integrate data from multiple devices, and track patients’ compliance with trial protocols.

New Angle

We developed a mobile application and passive monitoring device integration suite to collect objective and subjective study measures remotely. By seamlessly integrating multiple data streams, we provide realtime feedback on participant compliance.

The mobile application forms part of the experimental protocol of the study Sleep in its Natural Environment, results for which will be available in late fall 2016.

New Technologies

Mobile application for sleep outcomes reporting, incorporating:

New Science

The application allows us to monitor patients in new ways, integrating multiple data streams from devices, cognitive assessments, and patient surveys. Because the data are obtained remotely and there is no need for a patient to enter a clinic, data can be collected longitudinally, for a much longer time frame than traditional sleep studies and at much higher resolution. For example, we are able to perform multiple cognitive assessments per day.

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