Analysis of Sleep Study Data to Assess Depressive Burden

This study evaluates the effectiveness of the MEB-001 device in assessing physiological parameters that provide a clinically significant depressive burden screener. This study uses objective physiological markers from MEB-001 to estimate the clinically significant depressive burden as subjectively reported by the subject with the BDI-II. This is a two (2)-phase, non-significant risk, cross-sectional, naturalistic, single-arm, multi-center study conducted under a common protocol and designed to: Phase 1: MEB-001 algorithm development (software medical device). Phase 2: Evaluate the effectiveness of the MEB-001 device in assessing physiological parameters that provide clinically significant depressive burden screener.