NCT05708222

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
715

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2024

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

1.9 years

First QC Date

September 25, 2022

Last Update Submit

July 10, 2024

Conditions

Depressive EpisodeDepressionDepressive DisorderDepressive Disorder, MajorDepression Mild

Keywords

Major Depressive EpisodesDepressionSleep Study

Outcome Measures

Primary Outcomes (1)

  • Development of software as a medical device for the assessment of current major depressive episodes.

    Evaluation of patient objective and subjective measures to develop algorithm to determine whether the patient is experiencing a current major depressive episode.

    24 months

Study Arms (2)

Self Reported Assessment

This group of patients will self report their answers to the MINI assessment.

Device: MEB-001

Clinician Interview Assessment

This group of patients will complete the MINI assessment via an interactive interview conducted by a qualified clinician.

Device: MEB-001

Interventions

MEB-001DEVICE

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 AssessmentSelf Reported Assessment

Eligibility Criteria

Age22 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Subjects must meet ALL the following conditions to be eligible to participate in the study:
  • Subject is age ≥ 22 years and ≤ 75 years.
  • Subject is undergoing polysomnography due to suspected primary or secondary sleep disorders.
  • Subject is willing and able to provide informed 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 diagnostic PSG study, as prescribed.

You may not qualify if:

  • Subjects will not be eligible, and they will not be recruited to participate in the study if any of the following conditions are present:
  • Subject has a pacemaker.
  • Subject has undergone a heart transplant.
  • Subject is undergoing a full night C-PAP titration study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Medbridge Healthcare

Bradenton, Florida, 34205, United States

Location

Lakeland Sleep Store

Blaine, Minnesota, 55449, United States

Location

Lakeland Sleep

Plymouth, Minnesota, 55441, United States

Location

Medbridge Healthcare

Clayton, North Carolina, 27520, United States

Location

Medbridge Healthcare

Raleigh, North Carolina, 27612, United States

Location

Medbridge Healthcare

Wilson, North Carolina, 27822, United States

Location

Ohio Sleep Solutions

Columbus, Ohio, 43004, United States

Location

Ohio Sleep Solutions

Grove City, Ohio, 43123, United States

Location

Medbridge Healthcare

North Charleston, South Carolina, 29406, United States

Location

Medbridge Healthcare

Sumter, South Carolina, 29150, United States

Location

Comprehensive Sleep Medicine Associates

Austin, Texas, 78757, United States

Location

Comprehensive Sleep Medicine Associates

Sugar Land, Texas, 77478, United States

Location

Comprehensive Sleep Medicine Associates

The Woodlands, Texas, 77381, United States

Location

Related Publications (6)

  • Caldirola D, Dacco S, Cuniberti F, Grassi M, Alciati A, Torti T, Perna G. First-onset major depression during the COVID-19 pandemic: A predictive machine learning model. J Affect Disord. 2022 Aug 1;310:75-86. doi: 10.1016/j.jad.2022.04.145. Epub 2022 Apr 27.

    PMID: 35489559RESULT

  • Caldirola D, Cuniberti F, Dacco S, Grassi M, Torti T, Perna G. Predicting New-Onset Psychiatric Disorders Throughout the COVID-19 Pandemic: A Machine Learning Approach. J Neuropsychiatry Clin Neurosci. 2022 Summer;34(3):233-246. doi: 10.1176/appi.neuropsych.21060148. Epub 2022 Mar 21.

    PMID: 35306830RESULT

  • Perna G, Dacco S, Alciati A, Cuniberti F, De Berardis D, Caldirola D. Childhood maltreatment history for guiding personalized antidepressant choice in major depressive disorder: Preliminary results from a systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Apr 20;107:110208. doi: 10.1016/j.pnpbp.2020.110208. Epub 2020 Dec 15.

    PMID: 33338557RESULT

  • Dacco S, Caldirola D, Grassi M, Alciati A, Perna G, Defillo A. High prevalence of major depression in US sleep clinics: the need for routine depression screening in sleep services. J Clin Sleep Med. 2023 Apr 1;19(4):835-836. doi: 10.5664/jcsm.10398.

    PMID: 36644846RESULT

  • Perna G, Alciati A, Dacco S, Grassi M, Caldirola D. Personalized Psychiatry and Depression: The Role of Sociodemographic and Clinical Variables. Psychiatry Investig. 2020 Mar;17(3):193-206. doi: 10.30773/pi.2019.0289. Epub 2020 Mar 12.

    PMID: 32160691RESULT

  • Perna G, Cuniberti F, Dacco S, Nobile M, Caldirola D. Impact of respiratory protective devices on respiration: Implications for panic vulnerability during the COVID-19 pandemic. J Affect Disord. 2020 Dec 1;277:772-778. doi: 10.1016/j.jad.2020.09.015. Epub 2020 Sep 7.

    PMID: 33065816RESULT

MeSH Terms

Conditions

DepressionDepressive DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Study Officials

  • Archie Defillo, MD

    Medibio Limited

    STUDY CHAIR

  • Melissa E Bruner, MS

    Medibio Limited

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2022

First Posted

February 1, 2023

Study Start

September 1, 2022

Primary Completion

July 9, 2024

Study Completion

July 9, 2024

Last Updated

July 11, 2024

Record last verified: 2024-07

Locations

US(13)