Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)

Sponsor

Medibio Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05708222

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

62.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to collect data to finalize the development of MEB-001 softward 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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Episode Depression Depressive Disorder Depressive Disorder, Major Depression Mild	Device: MEB-001

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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.

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

Development of software as a medical device for the assessment of current major depressive episodes. [24 months]
Evaluation of patient objective and subjective measures to develop algorithm to determine whether the patient is experiencing a current major depressive episode.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.