Analysis of Sleep Study Data to Assess Depressive Burden

Sleep Disorder Clinical Trial

— SADB  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232267
• Other study ID #: CIP-0018
• Status: Completed
• Start date: January 13, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: December 2023
• Source: Medibio Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depressive; Behavioral Disorder
• Mood Disorders
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• MEB-001
Software medical device used to aid in the screening of patients with potential depressive burden symptoms.

Locations

Country	Name	City	State
United States	Restore Sleep Clinic	Blaine	Minnesota
United States	Ohio Sleep Solutions	Columbus	Ohio
United States	Ohio Sleep Solutions	Grove City	Ohio
United States	Ohio Sleep Solutions	Hilliard	Ohio
United States	Lakeland Sleep and CPAP	Plymouth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Medibio Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	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).