Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

715 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-07-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analysis of Sleep Study Data to Assess Depressive Burden

NCT04232267

Sleep Disorder Depressive; Behavioral Disorder Mood Disorders

COMPLETED

A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)

NCT07258485

Depressive Disorder, Major

RECRUITING

Objective Evaluation of Depression Using Sleep EEG

NCT03133013

Depression

COMPLETED NA

Sensor-based Characterization of Depression

NCT04370002

Unipolar Depression

RECRUITING

Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety

NCT07279038

Depression Disorders Anxiety Disorders

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Episode Depression Depressive Disorder Depressive Disorder, Major Depression Mild

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Self Reported Assessment

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

MEB-001

Intervention Type DEVICE

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.

MEB-001

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No