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NCT05708222 · ClinicalTrials.gov registry record
Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)
A clinical trial of Depression and Depressive Disorder, Major, sponsored by Medibio Limited.
- Completed
- Registry status
- 715
- Enrollment target
- 13
- Study locations
NCT05708222 is a study of Depression and Depressive Disorder, Major that has completed, run by Medibio Limited. The registered enrollment target is 715 participants, roughly in line with the 785-participant average among 679 other Depression trials with a reported enrollment target. The trial reports 13 study locations across 6 states.
The verdict
NCT05708222, a study of Depression and Depressive Disorder, Major, has completed, sponsored by Medibio Limited.
- COMPLETED
- Registry status
- 715 participants
- Enrollment target
- 13
- Study locations
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 Studied
Interventions
- DEVICE MEB-001
Study Locations (13)
North Carolina
- Medbridge Healthcare - Clayton
- Medbridge Healthcare - Raleigh
- Medbridge Healthcare - Wilson
Texas
- Comprehensive Sleep Medicine Associates - Austin
- Comprehensive Sleep Medicine Associates - Sugar Land
- Comprehensive Sleep Medicine Associates - The Woodlands
Minnesota
- Lakeland Sleep Store - Blaine
- Lakeland Sleep - Plymouth
Ohio
- Ohio Sleep Solutions - Columbus
- Ohio Sleep Solutions - Grove City
South Carolina
- Medbridge Healthcare - North Charleston
- Medbridge Healthcare - Sumter
Florida
- Medbridge Healthcare - Bradenton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 715 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2024-07-09 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05708222
The ClinicalTrials.gov registry entry for NCT05708222 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 715 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 785-participant average among 679 other Depression trials with a reported enrollment target. The listed sponsor is Medibio Limited, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which MEB-001 is the first listed.
NCT05708222 reports 13 study locations spanning 6 distinct geographic areas - top geographies include North Carolina, Texas, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05708222 about?
NCT05708222 is a clinical study titled "Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)". 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...
What is the current status of trial NCT05708222?
This trial is currently completed. The enrollment target is 715 participants. The study started on 2022-09-01. Estimated completion is 2024-07-09.
What conditions does trial NCT05708222 study?
This clinical trial studies the following conditions: Depression, Depressive Disorder, Major, Depressive Disorder, Depression Mild, Depressive Episode.
What interventions are being tested in trial NCT05708222?
The interventions under investigation include: MEB-001 (DEVICE).
Who is sponsoring clinical trial NCT05708222?
This trial is sponsored by Medibio Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05708222 being conducted?
This trial has 13 study locations across Florida, Minnesota, North Carolina, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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