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NCT05708222
Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)
Conditions: Depressive Episode, Depression, Depressive Disorder, Depressive Disorder, Major, Depression Mild
Sex: All
Ages: 22 Years – 75 Years
Enrollment: 1000
Sponsor: Medibio Limited
Location: United States
Summary
The objective of this study is to collect data to finalize the development of MEB-001 softward 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.
Eligibility Criteria
Inclusion Criteria: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.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:Subject has a pacemaker.Subject has undergone a heart transplant.Subject is undergoing a full night C-PAP titration study.
Source: ClinicalTrials.gov (NCT05708222). StuddyBuddy aggregates publicly available trial information.