Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) (SAMDE)

July 10, 2024 updated by: Medibio Limited

Investigation of the Likelihood of a Current Major Depressive Episode in Individuals Referred to Sleep Clinics for Polysomnography (PSG) Assessment Using the MEB-001 Device.

The objective of this study is to collect data to finalize the development of MEB-001 software as a medical device. The data collected in this study will be used to develop MEB-001 machine learning algorithms by training the algorithms to match the patient's demographic and clinical information, and the objective physiological signals (i.e., electroencephalogram (EEG) and electrocardiogram (ECG)) recorded during PSG with the diagnosis of cMDE performed through the MINI neuropsychiatric evaluation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a two (2)-phase, single-arm, prospective, non-significant risk, multi-center trial where each enrolled subject's data will be used for the development of MEB-001.

Study Population:

Subjects who are at least 22 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 evaluated for participation in this study.

The selection of the population involved in the study will consider the geographic diversity needed to obtain a representative sample of the intended use population. Centers will be selected to secure geographic and clinical diversity across the USA to obtain a representative distribution of the intended patient population.

All patients undergoing PSG due to primary or secondary sleep disorders, which include, but are not limited to, Sleep-Related Movement Disorders, Sleep-Related Breathing Disorders, Intrinsic and Extrinsic Circadian Rhythm Sleep-Wake Disorders, Hypersomnia, Parasomnia, and Insomnia, will be consecutively recruited, according to the inclusion/exclusion criteria.

Study Type

Observational

Enrollment (Actual)

715

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34205
        • Medbridge Healthcare
    • Minnesota
      • Blaine, Minnesota, United States, 55449
        • Lakeland Sleep Store
      • Plymouth, Minnesota, United States, 55441
        • Lakeland Sleep
    • North Carolina
      • Clayton, North Carolina, United States, 27520
        • Medbridge Healthcare
      • Raleigh, North Carolina, United States, 27612
        • Medbridge Healthcare
      • Wilson, North Carolina, United States, 27822
        • Medbridge Healthcare
    • Ohio
      • Columbus, Ohio, United States, 43004
        • Ohio Sleep Solutions
      • Grove City, Ohio, United States, 43123
        • Ohio Sleep Solutions
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Medbridge Healthcare
      • Sumter, South Carolina, United States, 29150
        • Medbridge Healthcare
    • Texas
      • Austin, Texas, United States, 78757
        • Comprehensive Sleep Medicine Associates
      • Sugar Land, Texas, United States, 77478
        • Comprehensive Sleep Medicine Associates
      • The Woodlands, Texas, United States, 77381
        • Comprehensive Sleep Medicine Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who are at least 22 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 evaluated for participation in this study.

Description

Inclusion Criteria:

Subjects must meet ALL the following conditions to be eligible to participate in the study:

  1. Subject is age ≥ 22 years and ≤ 75 years.
  2. Subject is undergoing polysomnography due to suspected primary or secondary sleep disorders.
  3. Subject is willing and able to provide informed consent.
  4. Subject has the ability to read and understand the instructions for the study.
  5. Subject is willing to adhere to study procedures.
  6. Subject is willing to undergo full night diagnostic PSG study, as prescribed.

Exclusion Criteria:

Subjects will not be eligible, and they will not be recruited to participate in the study if any of the following conditions are present:

  1. Subject has a pacemaker.
  2. Subject has undergone a heart transplant.
  3. Subject is undergoing a full night C-PAP titration study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Self Reported Assessment
This group of patients will self report their answers to the MINI assessment.
Device: MEB-001
The study is for the development of a software medical device. The study participant will complete study specific questionnaires and undergo a routine sleep study. The medical device will not provide any treatment or interventions.
Clinician Interview Assessment
This group of patients will complete the MINI assessment via an interactive interview conducted by a qualified clinician.
Device: MEB-001
The study is for the development of a software medical device. The study participant will complete study specific questionnaires and undergo a routine sleep study. The medical device will not provide any treatment or interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of software as a medical device for the assessment of current major depressive episodes.
Time Frame: 24 months
Evaluation of patient objective and subjective measures to develop algorithm to determine whether the patient is experiencing a current major depressive episode.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medibio Limited

Investigators

  • Study Chair: Archie Defillo, MD, Medibio Limited
  • Study Director: Melissa E Bruner, MS, Medibio Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

July 9, 2024

Study Completion (Actual)

July 9, 2024

Study Registration Dates

First Submitted

September 25, 2022

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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