A System for Management of Nasal CPAP Therapy

描述（由申请人提供）：总体目标是开发仪器和程序，通过(a)每日测量和审查多种生理参数，(b)评估患者依从性和主观反应，(c)监测治疗设备的完整性和有效性，以及(d)促进和加快任何治疗调整，来评估和优化无人在家环境下睡眠呼吸障碍（SDB）的气道正压（PAP）治疗。所有这些活动都将使用安全的Internet Web站点从远程位置自动实现。这项工作将利用市售的反射式脉搏氧饱和度传感器，该传感器经过修改后可合并压力控制，并安装在现有市售患者接口的前额支撑中，用于鼻气道正压治疗。血氧测量信息将记录在一个支持互联网的“Home-Hub”设备中，该设备还将测量和记录鼻腔气流、气流波形、口罩/口腔漏气、打鼾、PAP压力、患者依从性、主观抱怨、生活质量测量以及PAP或通气支持设备的完整性和性能。每天，这些数据将被自动访问并上传到一个安全的互联网网站，以便立即进行自动审查，并（如有必要）由合格的临床专家进行进一步评估和临床干预。患者还可以使用Home-Hub与网站进行交互。尤其是睡眠呼吸障碍和阻塞性睡眠呼吸暂停（OSA），是一种常见的、通常严重的、有时危及生命的疾病，是心血管疾病（包括高血压、心律失常、心力衰竭和中风）和清醒时功能障碍（工业和汽车事故以及失业的主要原因）的主要危险因素。阻塞性睡眠呼吸暂停最有效的治疗方法是通过一种叫做鼻腔cpap的设备来增加空气压力，从而防止睡眠时上呼吸道塌陷；然而，能够监测这种治疗的疗效以及患者遵守治疗的能力通常是重要的，有时是必要的。

DESCRIPTION (provided by applicant): The overall objective is to Develop Apparatus and Procedures to Assess and Optimize positive airway pressure (PAP) treatment of sleep-disordered breathing (SDB) in the Unattended Home Environment by - (a) Daily Measurement and Review of Multiple Physiological Parameters, (b) Assessment of Patient Compliance and Subjective Response, (c) Monitoring the Integrity and Efficacy of the Therapeutic Device, and (d) Facilitating and Expediting any therapeutic adjustment. All these Activities are to be automatically implemented from a remote location using a secure Internet Web Site. The work will utilize a commercially available reflectance Pulse Oximetry Sensor modified to incorporate pressure control and be installed into the forehead support of existing commercially available patient interfaces for nasal positive airway pressure treatment. The oximetry information will be recorded in an Internet-enabled, "Home-Hub" device that will also measure and record nasal airflow, airflow wave form, mask/mouth air leak, snoring, PAP pressure, patient compliance, subjective complaints, quality-of-life measures, and the integrity and performance of the PAP or ventilatory support device. Each day, the data will be automatically accessed and uploaded to a secure, Internet Web Site for immediate automatic review, and (as necessary) further evaluation by qualified clinical specialists and clinical intervention. The patient can also use the Home-Hub to initiate an interaction with the web site. Sleep Disordered Breathing and Obstructive Sleep Apnea (OSA) in particular, is a common, often serious, and sometimes life-threatening disorder that is a major risk factor for cardiovascular disease (including hypertension, cardiac arrhythmias, heart-failure and stroke) and functional impairment during wakefulness (a major cause of industrial and automobile accidents, and work loss). The most effective treatment for OSA prevents the upper airway collapse during sleep by increasing the air pressure by a device called nasal-CPAP; however it is usually important and sometimes essential to be able to monitor the efficacy of this treatment as well as the ability of the patient to comply with the therapy.