Analysis of Sleep Study Data to Assess Depressive Burden

Completed

• Conditions: Sleep Disorder; Depressive; Behavioral Disorder; Mood Disorders
• Interventions: Device: MEB-001

• Registration Number: NCT04232267
• Lead Sponsor: Medibio Limited

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-01-07
• Study Start: 2020-01-13
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed Polysomnology (PSG - sleep study)	MEB-001	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.

Primary Outcome Measures

Name	Time	Method
Report assists in the detection of clinically significant depressive burden.	The study consists of 1 study visit (baseline).	Utilize PSG data and BDI-II to determine clinical depressive burden.
Evaluate algorithm accuracy, sensitivity and specificity.	The study consists of 1 study visit (baseline).	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)

Secondary Outcome Measures

Name	Time	Method
System reliability and internal consistency.	The study consists of 1 study visit (baseline).	The MEB-001 is able to assess clinically depressive burden compared to the BDI-II
Evaluate positive predictive value and negative predictive value in detecting clinically significant depressive burden.	The study consists of 1 study visit (baseline).	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)

Trial Locations

Locations (3)

Lakeland Sleep and CPAP; 🇺🇸 Plymouth, Minnesota, United States

Restore Sleep Clinic; 🇺🇸 Blaine, Minnesota, United States

Ohio Sleep Solutions; 🇺🇸 Hilliard, Ohio, United States