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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients prescribed Polysomnology (PSG - sleep study) | Patients that are at least 18 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEB-001 | Device | Software medical device used to aid in the screening of patients with potential depressive burden symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Report assists in the detection of clinically significant depressive burden. | Utilize PSG data and BDI-II to determine clinical depressive burden. | The study consists of 1 study visit (baseline). |
| Evaluate algorithm accuracy, sensitivity and specificity. | 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) | The study consists of 1 study visit (baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate positive predictive value and negative predictive value in detecting clinically significant depressive burden. | 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) | The study consists of 1 study visit (baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who are at least 18 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbances and sign an informed consent form (ICF) will be eligible to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Bruner | Medibio Limited | Study Director |
| Archie Defillo, MD | Medibio Limited | Study Chair |
| Archie Defillo, MD | Medibio Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Restore Sleep Clinic | Blaine | Minnesota | 55434 | United States | ||
| Lakeland Sleep and CPAP |
There is no plan to share the participant data to other researchers.
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| System reliability and internal consistency. | The MEB-001 is able to assess clinically depressive burden compared to the BDI-II | The study consists of 1 study visit (baseline). |
| Plymouth |
| Minnesota |
| 55441 |
| United States |
| Ohio Sleep Solutions | Columbus | Ohio | 43214 | United States |
| Ohio Sleep Solutions | Grove City | Ohio | 43123 | United States |
| Ohio Sleep Solutions | Hilliard | Ohio | 43026 | United States |