Developing Novel Patient-Centric Digital Sleep Assessment Tools for People with Short and Disrupted Sleep

FDA and the Digital Medicine Society recently conducted a two-day workshop entitled “Using patient-generated health data in medical device development.” One of VivoSense’s senior research scientists, Jen Blankenship, PhD, presented key considerations for developing novel patient-centric digital sleep assessment tools. Jen discussed the benefits and challenges of wrist actigraphy sensors as a sleep assessment tool, particularly for individuals with sleep problems. Although wrist actigraphy sensors offer the benefit of low patient burden and continuous monitoring, particular care must be exercised when analyzing the data to ensure the proper classification of sleep/wake states and ultimately derive the outcomes that matter to patients, like sleep latency, duration, and efficiency.

VivoSense will be launching a new study at home that aims to further develop and validate the VivoSense sleep detection algorithm to assess sleep more reliably in populations with sleep problems and address the limitations of existing solutions. A novel component of this study includes providing a report summarizing the DHT-derived sleep data back to participants, and researchers will re-engage with participants to evaluate their perspectives on the meaningfulness of provided DHT-derived sleep data.

Continuous patient engagement throughout the entire digital measure development process is central to developing patient-centric tools that will fit unmet needs and enable improved digital solutions that support developing and evaluating novel treatments that impact patient lives.

View the Presentation Here