Non-Contact Point of Care Device for Sleep Studies

用于睡眠研究的非接触式护理设备

• 批准号: 9770764
• 负责人: John Paul Condon
• 金额: $ 79.53万
• 依托单位: INNOVATIVE DESIGN LABS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9770764
• 关键词: Abdomen; Affect; Algorithmic Software; Algorithms; American; Calibration; Cannulas; Chest; Child; Clinic; Clinical; Collaborations; Complex; Computer software; Consult; Databases; Development; Developmental Disabilities; Devices; Diabetes Mellitus; Diagnosis; Diagnostic Equipment; Diagnostic Services; Disabled Persons; Disease; Elderly; Electroencephalography; Ensure; Evaluation; Gel; Goals; Gold; Health; Health Insurance Portability and Accountability Act; Heart Diseases; Heart Rate; Home environment; Individual; Instruction; Lung; Measurement; Medical; Medical Device; Medicine; Mental Depression; Mentally Disabled Persons; Methods; Minnesota; Modality; Modeling; Monitor; Motion; Movement; Neurofibrillary Tangles; Non-Insulin-Dependent Diabetes Mellitus; Nose; Obstructive Sleep Apnea; Outcome; Patients; Performance; Phase; Physician Executives; Plethysmography; Polysomnography; Population; Pressure Transducers; Prevalence; Production; Pulmonology; Quality of life; Radar; Reporting; Research; Resolution; Respiratory Failure; Respiratory physiology; Rural Population; Scientist; Severities; Signal Transduction; Skin; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Small Business Innovation Research Grant; Study Subject; System; Technology; Testing; Time; Touch sensation; Underinsured; Underserved Population; United States National Institutes of Health; Universities; attenuation; base; cloud based; cost; design; diagnosis standard; disorder control; epidemiology study; experience; human study; human subject; innovation; novel strategies; operation; point of care; portability; portable monitoring; pressure; professor; programs; prototype; respiratory; sensor; sensor technology; signal processing; sleep position; sleep quality; standard measure; wearable device; wireless fidelity

Project Summary/Abstract Proposed is an easy-to-use, portable method for diagnosis of obstructive sleep apnea (OSA) using non-contact technology for use in clinical or home setting. Significance: An estimated 18 million Americans have sleep apnea and recent epidemiological studies indicate the prevalence of this disorder is on the rise. OSA is associated with several negative health outcomes including depression and type 2 diabetes. Currently, polysomnography (PSG) is the gold standard test for diagnosis of OSA. PSG systems are complex. They typically require a skilled technician for setup and continuous monitoring to ensure the accuracy of results thereby limiting their use to sleep clinics. However, recent reviews of access to sleep clinics have found supply of OSA diagnostic services not always able to meet demand. Home sleep apnea test (HSAT) systems do exist, however, like current PSG systems, they employ sensing modalities that suffer from issues of miscalibration or diminished efficacy as the user moves through the night. Sensors typically used by HSAT systems (nose worn cannula, EEG, plethysmography belts, etc.) must be in direct contact with the patient and are wired to a central recorder that the patient must wear. Patients report that worn/wired sensors are uncomfortable and in some cases affect their sleep quality. These issues present a barrier to effective diagnosis of OSA for many populations including the un/under-insured, rural populations, individuals with accessibility needs, those with developmental disabilities, and children. Hypothesis: It is hypothesized that an easy-to-use non-contact system capable of sensing standard measures of sleep apnea severity (AHI) will make available diagnosis to several populations underserved by current PSG and HSAT technology thereby increasing quality of life for those individuals effected by OSA. Specific Aims: In the Phase I effort the proposed sensing technology was demonstrated to be exceptionally effective. In Phase II the following aims are proposed: 1) Mature the prototype hardware into a production ready system, 2) Finalize processing software and develop interfaces for end users / clinicians, and 3) Validate system performance against current state-of-the-art system in a human subject study.

项目总结/摘要 提出了一种使用非接触式诊断阻塞性睡眠呼吸暂停（OSA）的简便、便携式方法。 用于临床或家庭环境的技术。上一篇：估计有1800万美国人有睡眠 呼吸暂停和最近的流行病学研究表明，这种疾病的发病率正在上升。OSA是 与包括抑郁症和2型糖尿病在内的几种负面健康结果相关。目前， 多导睡眠图（PSG）是诊断OSA的金标准测试。PSG系统很复杂。他们 通常需要熟练的技术人员进行设置和连续监测以确保结果的准确性 从而限制了它们在睡眠诊所的使用。然而，最近对睡眠诊所的访问进行的审查发现， OSA诊断服务并不总是能够满足需求。家庭睡眠呼吸暂停测试（HSAT）系统确实存在， 然而，与当前的PSG系统一样，它们采用的感测模态存在误校准问题， 随着使用者在夜间移动而降低功效。HSAT系统通常使用的传感器（鼻戴式 插管、EEG、体积描记带等）必须与患者直接接触，并连接到中央 患者必须佩戴的记录仪。患者报告磨损/有线传感器不舒服，在某些情况下， 影响睡眠质量。这些问题对许多人来说是有效诊断OSA的障碍。 人口，包括未投保/投保不足的人口、农村人口、有无障碍需求的个人、 发育障碍和儿童。假设：假设易于使用的非接触式 一种能够检测睡眠呼吸暂停严重程度（AHI）标准测量值的系统将提供诊断， 目前PSG和HSAT技术服务不足的一些人群，从而提高了生活质量， 那些受OSA影响的人具体目标：在第一阶段的工作中，提出的传感技术是 被证明非常有效。在第二阶段，提出了以下目标： 将原型硬件转化为生产就绪系统，2）完成处理软件并开发接口， 最终用户/临床医生，以及3）在人体中对比当前最先进系统的系统性能 课题研究