Developing a Sleep Algxorithm to Support a Digital Medicine System: Noninterventional, Observational Sleep Study.

ABSTRACT:

Background

Sleep-wake patterns are important behavioral biomarkers for patients with serious mental illness (SMI), providing insight into their well-being. The gold standard for monitoring sleep is polysomnography (PSG), which requires a sleep lab facility; however, advances in wearable sensor technology allow for real-world sleep-wake monitoring.

Objective

The goal of this study was to develop a PSG-validated sleep algorithm using accelerometer (ACC) and electrocardiogram (ECG) data from a wearable patch to accurately quantify sleep in a real-world setting.

Methods

In this noninterventional, nonsignificant-risk, abbreviated investigational device exemption, single-site study, participants wore the reusable wearable sensor version 2 (RW2) patch. The RW2 patch is part

SUBMITTER: Cochran JM 

PROVIDER: S-EPMC11683743 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature