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Completed

NCT Number: NCT04232267

Analysis of Sleep Study Data to Assess Depressive Burden

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).

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Key information

Conditions

Sleep Disorder Depressive; Behavioral Disorder Mental Disorders Mood Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Restore Sleep Clinic, Blaine, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MEB-001

Device

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

Primary outcomes

  1. Report assists in the detection of clinically significant depressive burden.

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

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

  2. Evaluate algorithm accuracy, sensitivity and specificity.

    Time frame: 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 outcomes

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

    Time frame: 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)

  2. System reliability and internal consistency.

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

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

Sponsors and collaborators

Lead sponsor

Medibio Limited

Industry

Registry information

Official study 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)

Acronym: SADB

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2020
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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