Intelligent Quantitative CPAP for OSA therapy

用于 OSA 治疗的智能定量 CPAP

• 批准号: 7056432
• 负责人: Hani Akram Kayyali
• 金额: $ 36.68万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7056432
• 关键词: automated data processing; bioengineering /biomedical engineering; biomedical equipment development; clinical research; electrocardiography; home health care; human subject; human therapy evaluation; miniature biomedical equipment; oximetry; patient care management; patient monitoring device; patient oriented research; portable biomedical equipment; positive pressure breathing; posture; respiratory airflow measurement; respiratory hypoxia; sleep apnea; telemetry; therapy compliance

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.

描述（由申请人提供）：长期目标是开发一类新的持续正气道压力（CPAP）设备，除了治疗OSA患者外，还可以同时进行心肺测量，以改善治疗评估。 CPAP是迄今为止最常见的疗法，对于阻塞性睡眠呼吸暂停（OSA）患者，每年启动300,000多种新疗法。不幸的是，一旦开了规定，CPAP治疗通常不会受到监测。为了正确评估症状，必须将患者带回实验室进行评估，这是昂贵，不便且等待时间长的。一些更高级的CPAP机器可以通过测量夜间的气流信号来监测患者的呼吸模式。但是，准确的患者评估需要同时评估多个心肺信息，以确认呼吸暂停，呼吸症，去饱和和心脏功能等事件。心肺信息还可以帮助对事件的起源进行分类，例如将中心与阻塞性事件区分开。研究发现，OSA患者，尤其是患有合并症的患者确实患有未解决的夜间事件，这些事件未使用当前技术检测到，并且需要进行其他治疗干预。此外，已经显示出详细的功效数据实际上可以通过快速干预和鼓励反馈来提高患者的依从性。我们建议开发一种新的CPAP设备，该设备可以监视心电图，胸部努力，脉搏血氧饱和度，身体位置和气流。预计所有参数的监测有望通过体重增加，饮酒，OSA症状复发或新并发症的出现来间歇性。当需要监测时，患者只需佩戴一个小的无线胸部模块，然后将数据自动传输到CPAP中，该CPAP配备了特殊的数据接收，存储能力和分析算法。 CPAP自动将数据下载到医生的办公室，包括原始波形和定量信息，例如AHI，去饱和轮廓和心率变异性。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。胸部模块可以轻松地为多个夜间记录充电。我们已经成功达到并超出了I期目标。我们开发并测试了无线硬盘，包括胸部模块和CPAP接口。对3名志愿者进行了测试。此外，我们进行了一项案例研究，显示CPAP期间未解决的明显夜间事件。当前技术将无法发现的事件。我们已经组建了一个为该项目提供出色的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，以确认性能并易于使用。将与当前CPAP技术和LAB PSG进行比较。