Analysis of Sleep Study Data to Assess Depressive Burden

Development and Validation of an Algorithm to Identify a Clinically Significant Depressive Burden in Individuals Referred to Sleep Clinics for Polysomnography (PSG) Assessment (Sleep Analysis of Depressive Burden - SADB)

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 Beck Depression Inventory - II (BDI-II).

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.

Inclusion Criteria:

• Subject is age ≥18 years and ≤75 years.
• Subject is willing and able to provide consent.
• Subject has the ability to read and understand the instructions for the study.
• Subject is willing to adhere to study procedures.
• Subject is willing to undergo full night PSG study, as prescribed.

Exclusion Criteria:

• Subject has a pacemaker.
• Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).