Analysis of Sleep Study Data to Assess Depressive Burden (SADB)

Medibio

Status: Completed

Conditions: Sleep Disorder; Depressive; Behavioral Disorder; Mood Disorders

Treatments: Device: MEB-001

Study type: Observational

Funder types: Industry

Identifiers

NCT04232267

CIP-0018

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 329 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

329 participants in 1 patient group

Patients prescribed Polysomnology (PSG - sleep study)

Description:

Patients that are at least 18 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbance.

Treatment:

Device: MEB-001