Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Depressive Episode, Depression, Depressive Disorder, Depressive Disorder, Major, Depression Mild

Intervention / Treatment
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* Device: MEB-001


Participation Criteria
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Eligibility Criteria
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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. 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: Subject has a pacemaker. Subject has undergone a heart transplant. Subject is undergoing a full night C-PAP titration study.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Self Reported Assessment<br>This group of patients will self report their answers to the MINI assessment. | Device: MEB-001<br>* 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.<br>|
| Clinician Interview Assessment<br>This group of patients will complete the MINI assessment via an interactive interview conducted by a qualified clinician. | Device: MEB-001<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Episodes, Depression, Sleep Study