Analysis of Sleep Study Data to Assess Depressive Burden

Medibio Limited329 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

329

Conditions

Sleep Disorder Depressive; Behavioral Disorder Mood Disorders

Interventions

MEB-001DEVICE

Software medical device used to aid in the screening of patients with potential depressive burden symptoms.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Locations (5)

Restore Sleep Clinic

Blaine, Minnesota, United States

Lakeland Sleep and CPAP

Plymouth, Minnesota, United States

Ohio Sleep Solutions

Columbus, Ohio, United States

Ohio Sleep Solutions

Grove City, Ohio, United States

Outcomes

Primary Outcomes

Report assists in the detection of clinically significant depressive burden.

Utilize PSG data and BDI-II to determine clinical depressive burden.

Time frame: The study consists of 1 study visit (baseline).

Evaluate algorithm accuracy, sensitivity and specificity.

Sensitivity: True Positive/BDI-II + (the percentage of BDI-II positives identified by MEB-001) Specificity: True Negative/BDI-II - (the percentage of BDI-II negatives identified by MEB-001)

Time frame: The study consists of 1 study visit (baseline).

Secondary Outcomes

Evaluate positive predictive value and negative predictive value in detecting clinically significant depressive burden.

Positive predictive value: True Positive/MEB-001 + (the percentage of MEB-001 positive test results that agree with BDI-II) Negative predictive value: True Negative/MEB-001 - (the percentage of MEB-001 negative test results that agree with BDI-II)

Time frame: The study consists of 1 study visit (baseline).

System reliability and internal consistency.

The MEB-001 is able to assess clinically depressive burden compared to the BDI-II

Time frame: The study consists of 1 study visit (baseline).

Data from ClinicalTrials.gov

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