Validation of a Wearable Non-invasive Device (the Patch) to Aid in Diagnosing Sleep Apnea
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Estimation of AHI
研究概览
简要总结
BresoTEC has designed and developed a standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject.
详细描述
The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2® with Bluetooth Low Energy. We have developed advanced signal processing algorithms to detect apneas and hypopneas. Many of these techniques for analyzing breathing sounds and detecting apneas and hypopneas have been published in peer-reviewed journals.
The goal of this study is to validate the patch against polysomnography (PSG) for use as an aid in the diagnosis of sleep apnea for adult patients. Our primary objective is to assess whether the estimated apnea-hypopnea index (AHI) calculated by the patch agrees with the results of an in-laboratory PSG.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The outcome assessor performing the automatic analysis of the patch data will be blinded to the PSG scores performed by the Sleep Lab Technicians.
The principal investigator responsible for the completion and closing of the study according to the protocol will be blinded to the patch AHI automatic analysis.
Similarly, the Sleep Lab Technicians scoring the PSG will be blinded to the patch automatic analysis.
By the end of recruiting the target sample size, the data will be un-blinded and statistical analysis will be performed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria are men and women 18 years and above, who are referred to either the University Health Network (UHN), Toronto Rehabilitation Institute (TRI) or Toronto General Hospital sleep laboratories for overnight PSG because of a suspicion of a sleep disorder. It is intended for the general outpatient population.
排除标准
- •Exclusion criteria are patients with suspected complicated co-morbidities including in-hospital patients and those who self-report diagnosis of heart failure, recent stroke, neuromuscular disorders, renal failure, obesity hypoventilation, COPD, or other severe lung diseases.
结局指标
主要结局
Estimation of AHI
时间窗: 8 months
Validate the performance of the patch in estimating the AHI compared to an in-laboratory PSG.
次要结局
- Estimation of body position(8 months)