Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)

Completed

• Conditions: Depression Mild; Depressive Episode; Depressive Disorder, Major; Depression; Depressive Disorder
• Interventions: Device: MEB-001

• Registration Number: NCT05708222
• Lead Sponsor: Medibio Limited

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.

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 Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-02-01
• Status Verified: 2024-07
• Primary Completion: 2024-07-09
• Study Completion: 2024-07-09
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 715

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinician Interview Assessment	MEB-001	This group of patients will complete the MINI assessment via an interactive interview conducted by a qualified clinician.
Self Reported Assessment	MEB-001	This group of patients will self report their answers to the MINI assessment.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Comprehensive Sleep Medicine Associates; 🇺🇸 The Woodlands, Texas, United States

Ohio Sleep Solutions; 🇺🇸 Grove City, Ohio, United States

Lakeland Sleep Store; 🇺🇸 Blaine, Minnesota, United States

Lakeland Sleep; 🇺🇸 Plymouth, Minnesota, United States

Medbridge Healthcare; 🇺🇸 Sumter, South Carolina, United States