Unlocking New Clinical Insights With Remote Captured Sleep Data

By Ellora Sen-Gupta, Director, Biomedical Engineering, Medidata, and Melissa Ceruolo, Senior Director, Biomarker Analytics, Medidata

Physicians, researchers, and drug developers need better data on sleep but capturing rich, real-world data in formal clinical trials has been difficult. Overnight polysomnography (PSG), the current gold standard for objective sleep data, requires trial participants to spend the night in a hospital or clinic wearing multiple wired sensors. It’s expensive for sponsors, intrusive for patients, time-consuming for evaluators, and yields a 1- or 2-day snapshot of sleep in an artificial setting. Self-reported outcome questionnaires and sleep diaries are subjective, and the quality of the data varies significantly by patient population. But the field is advancing rapidly, and sponsors can’t afford to wait on the sidelines until the devices, algorithms, and methodologies have been perfected. Here are three ways to start collecting quality sleep data remotely by leveraging cloud-based data ingestion and processing.