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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 329
- 试验地点
- 3
- 主要终点
- Report assists in the detection of clinically significant depressive burden.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Subject has a pacemaker.
- •Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).
结局指标
主要结局
Report assists in the detection of clinically significant depressive burden.
时间窗: 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.
时间窗: 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)
次要结局
- System reliability and internal consistency.(The study consists of 1 study visit (baseline).)
- Evaluate positive predictive value and negative predictive value in detecting clinically significant depressive burden.(The study consists of 1 study visit (baseline).)