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Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)
NCT05708222 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 715 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medibio Limited, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05708222 reports 13 study locations spanning 6 distinct geographic areas — top geographies include North Carolina, Texas, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05708222?
The interventions under investigation include: MEB-001 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05708222?
This trial is sponsored by Medibio Limited, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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