Trials / Completed
CompletedNCT04232267
Analysis of Sleep Study Data to Assess Depressive Burden
Development and Validation of an Algorithm to Identify a Clinically Significant Depressive Burden in Individuals Referred to Sleep Clinics for Polysomnography (PSG) Assessment (Sleep Analysis of Depressive Burden - SADB)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 329 (actual)
- Sponsor
- Medibio Limited · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MEB-001 | Software medical device used to aid in the screening of patients with potential depressive burden symptoms. |
Timeline
- Start date
- 2020-01-13
- Primary completion
- 2022-03-01
- Completion
- 2022-03-01
- First posted
- 2020-01-18
- Last updated
- 2023-12-21
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04232267. Inclusion in this directory is not an endorsement.