Depressive; Behavioral Disorder, Mood Disorders, Sleep Disorder
Conditions
Brief summary
This study evaluates the effectiveness of the MEB-001 device in assessing physiological parameters that provide a clinically significant depressive burden screener. This study uses objective physiological markers from MEB-001 to estimate the clinically significant depressive burden as subjectively reported by the subject with the Beck Depression Inventory - II (BDI-II).
Detailed description
This study evaluates the effectiveness of the MEB-001 device in assessing physiological parameters that provide a clinically significant depressive burden screener. This study uses objective physiological markers from MEB-001 to estimate the clinically significant depressive burden as subjectively reported by the subject with the BDI-II. This is a two (2)-phase, non-significant risk, cross-sectional, naturalistic, single-arm, multi-center study conducted under a common protocol and designed to: Phase 1: MEB-001 algorithm development (software medical device). Phase 2: Evaluate the effectiveness of the MEB-001 device in assessing physiological parameters that provide clinically significant depressive burden screener.
Interventions
DEVICEMEB-001
Software medical device used to aid in the screening of patients with potential depressive burden symptoms.
Sponsors
Medibio Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject is age ≥18 years and ≤75 years. * Subject is willing and able to provide 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 PSG study, as prescribed.
Exclusion criteria
* Subject has a pacemaker. * Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Report assists in the detection of clinically significant depressive burden. | The study consists of 1 study visit (baseline). | Utilize PSG data and BDI-II to determine clinical depressive burden. |
| Evaluate algorithm accuracy, sensitivity and specificity. | The study consists of 1 study visit (baseline). | Sensitivity: True Positive/BDI-II + (the percentage of BDI-II positives identified by MEB-001) Specificity: True Negative/BDI-II - (the percentage of BDI-II negatives identified by MEB-001) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate positive predictive value and negative predictive value in detecting clinically significant depressive burden. | The study consists of 1 study visit (baseline). | Positive predictive value: True Positive/MEB-001 + (the percentage of MEB-001 positive test results that agree with BDI-II) Negative predictive value: True Negative/MEB-001 - (the percentage of MEB-001 negative test results that agree with BDI-II) |
| System reliability and internal consistency. | The study consists of 1 study visit (baseline). | The MEB-001 is able to assess clinically depressive burden compared to the BDI-II |
Countries
United States
Outcome results
None listed