Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)
Completed
Conditions studied: Depressive Episode, Depression, Depressive Disorder, Depressive Disorder, Major, Depression Mild
In brief
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.
Key facts
- Study ID
- NCT05708222
- Run by
- Medibio Limited
- People needed
- 715
- Starts
- 2022-09-01
- Expected to finish
- 2024-07-09
- Last updated by the study team
- 2024-07-11
Who can join
Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must meet ALL the following conditions to be eligible to participate in the study:
- Subject is age ≥ 22 years and ≤ 75 years.
- Subject is undergoing polysomnography due to suspected primary or secondary sleep disorders.
- Subject is willing and able to provide informed consent.
- Subject has the ability to read and understand the instructions for the study.
- Subject is willing to adhere to study procedures.
- Subject is willing to undergo full night diagnostic PSG study, as prescribed.
You may not qualify if…
- Subjects will not be eligible, and they will not be recruited to participate in the study if any of the following conditions are present:
- Subject has a pacemaker.
- Subject has undergone a heart transplant.
- Subject is undergoing a full night C-PAP titration study.
Where it is running
- Medbridge Healthcare — Bradenton, Florida, United States
- Lakeland Sleep Store — Blaine, Minnesota, United States
- Lakeland Sleep — Plymouth, Minnesota, United States
- Medbridge Healthcare — Clayton, North Carolina, United States
- Medbridge Healthcare — Raleigh, North Carolina, United States
- Medbridge Healthcare — Wilson, North Carolina, United States
- Ohio Sleep Solutions — Columbus, Ohio, United States
- Ohio Sleep Solutions — Grove City, Ohio, United States
- Medbridge Healthcare — North Charleston, South Carolina, United States
- Medbridge Healthcare — Sumter, South Carolina, United States
- Comprehensive Sleep Medicine Associates — Austin, Texas, United States
- Comprehensive Sleep Medicine Associates — Sugar Land, Texas, United States
- Comprehensive Sleep Medicine Associates — The Woodlands, Texas, United States
Full record on ClinicalTrials.gov
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