Analysis of Sleep Study Data to Assess Depressive Burden

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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)

Conditions
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Sleep Disorder, Depressive; Behavioral Disorder, Mood Disorders

Intervention / Treatment
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* Device: MEB-001


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed Polysomnology (PSG - sleep study)<br>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. | Device: MEB-001<br>* Software medical device used to aid in the screening of patients with potential depressive burden symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report assists in the detection of clinically significant depressive burden. | Utilize PSG data and BDI-II to determine clinical depressive burden. | 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) | The study consists of 1 study visit (baseline). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | The study consists of 1 study visit (baseline). |