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Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)

NCT05708222 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 715

Last updated 2024-07-11

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medibio Limited

    lead INDUSTRY

Principal Investigators

  • Archie Defillo, MD · Medibio Limited

  • Melissa E Bruner, MS · Medibio Limited

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-07-09
Completion
2024-07-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05708222 on ClinicalTrials.gov