Intelligent Quantitative CPAP for OSA therapy

描述（由申请人提供）：长期目标是开发一种新型的持续气道正压通气（CPAP）设备，除了治疗OSA患者外，还可以同时进行心肺测量，以改进治疗评估。到目前为止，CPAP是阻塞性睡眠呼吸暂停（OSA）患者最常用的治疗方法，每年有超过30万种新疗法启动。不幸的是，一旦开了处方，CPAP治疗通常没有监测。为了正确地评估症状，必须将患者带回实验室进行评估，这既昂贵又不方便，而且等待时间很长。一些更先进的CPAP机器可以通过测量夜间气流信号来监测病人的呼吸模式。然而，准确的患者评估需要同时评估多种心肺信息，以确认诸如呼吸暂停、呼吸不足、去饱和和心功能等事件。心肺信息也可以帮助分类事件的起源，如区分中枢和阻塞性事件。研究发现，OSA患者，特别是那些有合并症的患者，确实存在未解决的夜间事件，这些事件是目前技术无法检测到的，需要额外的治疗干预。此外，详细的疗效数据显示，通过快速干预和鼓励反馈，实际上提高了患者的依从性。我们建议开发一种新的CPAP设备，可以监测心电图、胸用力、脉搏血氧、体位和气流。所有参数的监测应是间歇性的，因为体重增加、饮酒、OSA症状复发或出现新的并发症。当需要监测时，患者只需佩戴一个小型无线Chest Module，数据自动传输到CPAP中，CPAP具有特殊的数据接收、存储能力和分析算法。CPAP会自动将数据下载到医生办公室，包括原始波形和定量信息，如AHI、去饱和度曲线和心率变异性。其结果是可以与实验室中进行的原始评估进行真正比较的功效数据。胸部模块可以很容易地为多个夜间录音充电。我们已经成功地达到并超过了第一阶段的目标。我们开发并测试了无线硬件，包括胸部模块和CPAP接口。在3名志愿者身上进行了测试。此外，我们进行了一个病例研究，显示CPAP期间未解决的重大夜间事件；用现在的技术是无法检测到的。我们为这个项目组建了一支具有优秀临床和商业专业知识的团队。在第二阶段，我们将完成设计，制造10个完整的系统，并对20名OSA患者进行测试，以确认其性能和易用性。将与当前CPAP技术和实验室PSG进行比较。

DESCRIPTION (provided by applicant): The long term objective is to develop a new class of Continuous Positive Airway Pressure (CPAP) devices that in addition to treating OSA patients can conduct simultaneous cardiorespiratory measurements for improved therapy assessment. CPAP is by far the most common therapy for patients with Obstructive Sleep Apnea (OSA) with over 300,000 new therapies initiated each year. Unfortunately, once prescribed, CPAP treatment is not typically monitored. In order to properly assess symptoms, patients must be brought back to the lab for evaluation, which is expensive, inconvenient and has long waiting periods. Some of the more advanced CPAP machines can monitor patient's breathing pattern by measuring the airflow signal during the night. However, accurate patient assessment requires simultaneous evaluation of multiple cardiorespiratory information to confirm events such as Apnea, Hypopneas, Desaturations, and Cardiac function. Cardiorespiratory information can also help classify the origin of the event such as differentiating central from obstructive events. Research found that OSA patients, especially those with comorbidities, do suffer from unresolved nocturnal events that were not detected using current technologies and that additional therapy intervention was needed. Also, detailed efficacy data has been shown to actually improve patient compliance through fast intervention and encouraging feedback. We propose to develop a new CPAP device that can monitor EKG, chest effort, pulse oximetry, body position, and airflow. Monitoring of all parameters is expected to be intermittent warranted by weight gain, alcohol use, resurgence of OSA symptoms, or emergence of new complications. When monitoring is needed, patients simply wear a small wireless Chest Module and data is transmitted automatically into the CPAP, which is equipped with special data reception, storage capability and analysis algorithms. The CPAP automatically downloads the data to the doctor's office including raw waveforms and quantitative information such as AHI, desaturation profiles, and heart rate variability. The result is efficacy data that can be truly compared with original assessment done in the lab. The Chest Module can be easily recharged for multiple night recordings. We have successfully met and exceeded Phase I objectives. We developed and tested wireless hardwdare including the Chest Module and a CPAP interface. Testing was done on 3 volunteers. Additionally, we conducted a case study that showed unresolved significant nocturnal events during CPAP; events that would have gone undetected with current technology. We have assembled a team with excellent clinical and commercial expertise for this project. In Phase II, we will finish the design, fabricate 10 complete systems and test on 20 OSA patients to confirm performance, and ease of use. Comparison with current CPAP techniques and in-lab PSG will be done.