Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)
Sponsored by Medibio Limited
About this trial
Last updated 2 years ago
Study ID
CIP-0089
Status
Completed
Type
Observational
Placebo
No
Accepting
22 to 75 Years
All Sexes
Trial Timing
Ended 2 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
Subjects must meet ALL the following conditions to be eligible to participate in the study:
1. Subject is age ≥ 22 years and ≤ 75 years.
2. Subject is undergoing polysomnography due to suspected primary or secondary sleep disorders.
3. Subject is willing and able to provide informed consent.
4. Subject has the ability to read and understand the instructions for the study.
5. Subject is willing to adhere to study procedures.
6. 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:
1. Subject has a pacemaker.
2. Subject has undergone a heart transplant.
3. Subject is undergoing a full night C-PAP titration study.