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

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).

Study Overview

• Status: Completed
• Conditions: Mood Disorders; Sleep Disorder; Depressive; Behavioral Disorder
• Intervention / Treatment: Device: MEB-001

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 329

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Blaine, Minnesota, United States, 55434
      • Restore Sleep Clinic
    • Plymouth, Minnesota, United States, 55441
      • Lakeland Sleep and CPAP
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Ohio Sleep Solutions
    • Grove City, Ohio, United States, 43123
      • Ohio Sleep Solutions
    • Hilliard, Ohio, United States, 43026
      • Ohio Sleep Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are at least 18 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbances and sign an informed consent form (ICF) will be eligible to participate in this study.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients prescribed Polysomnology (PSG - sleep study); 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; Software medical device used to aid in the screening of patients with potential depressive burden symptoms.

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Medibio Limited
• Investigators: Study Chair: Archie Defillo, MD, Medibio Limited; Study Director: Melissa Bruner, Medibio Limited; Principal Investigator: Archie Defillo, MD, Medibio Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Mood Disorders
• Other Study ID Numbers: CIP-0018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share the participant data to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No