Investigation of the Likelihood of a Current Major Depressive Episode in Individuals Referred to Sleep Clinics for Polysomnography (PSG) Assessment Using the MEB-001 Device.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 715
- 试验地点
- 5
- 主要终点
- Development of software as a medical device for the assessment of current major depressive episodes.
研究概览
简要总结
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.
详细描述
This is a two (2)-phase, single-arm, prospective, non-significant risk, multi-center trial where each enrolled subject's data will be used for the development of MEB-001.
Study Population:
Subjects who are at least 22 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 evaluated for participation in this study.
The selection of the population involved in the study will consider the geographic diversity needed to obtain a representative sample of the intended use population. Centers will be selected to secure geographic and clinical diversity across the USA to obtain a representative distribution of the intended patient population.
All patients undergoing PSG due to primary or secondary sleep disorders, which include, but are not limited to, Sleep-Related Movement Disorders, Sleep-Related Breathing Disorders, Intrinsic and Extrinsic Circadian Rhythm Sleep-Wake Disorders, Hypersomnia, Parasomnia, and Insomnia, will be consecutively recruited, according to the inclusion/exclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet ALL the following conditions to be eligible to participate in the study:
- •Subject is age ≥ 22 years and ≤ 75 years.
- •Subject is undergoing polysomnography due to suspected primary or secondary sleep disorders.
- •Subject is willing and able to provide informed 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 diagnostic PSG study, as prescribed.
排除标准
- •Subjects will not be eligible, and they will not be recruited to participate in the study if any of the following conditions are present:
- •Subject has a pacemaker.
- •Subject has undergone a heart transplant.
- •Subject is undergoing a full night C-PAP titration study.
结局指标
主要结局
Development of software as a medical device for the assessment of current major depressive episodes.
时间窗: 24 months
Evaluation of patient objective and subjective measures to develop algorithm to determine whether the patient is experiencing a current major depressive episode.
次要结局
未报告次要终点