A System for Management of Nasal CPAP Therapy

经鼻 CPAP 治疗管理系统

• 批准号: 7108871
• 负责人: LAUGHTON ERIC MILES
• 金额: $ 11.2万
• 依托单位: VITALOG, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-19 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7108871
• 关键词: Internet; biomedical equipment development; clinical research; computer assisted patient care; home health care; human subject; oximetry; patient monitoring device; positive pressure breathing; telemedicine; therapy compliance

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.

描述（申请人提供）：总体目标是开发评估和优化无人值守家庭环境中睡眠呼吸障碍（SD B）的气道正压通气（PAP）治疗的设备和程序，方法是：（a）每日测量和审查多个生理参数，（B）评估患者依从性和主观反应，（c）监测治疗器械的完整性和有效性，及（d）促进及加快任何治疗调整。所有这些活动都将使用安全的互联网网站从远程位置自动实施。这项工作将使用市售反射式脉搏血氧饱和度传感器，该传感器经过改良，可纳入压力控制，并安装在现有市售患者接口的前额支架上，用于鼻气道正压通气治疗。血氧测定信息将记录在支持互联网的“家庭集线器”设备中，该设备还将测量和记录鼻气流、气流波形、面罩/口腔漏气、打鼾、PAP压力、患者依从性、主观主诉、生活质量测量以及PAP或呼吸支持设备的完整性和性能。每天，数据将自动访问并上传到安全的互联网网站，以便立即进行自动审查，并（必要时）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启动与网站的交互。特别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）和清醒期间功能障碍（工业和汽车事故以及工作损失的主要原因）的主要风险因素。OSA最有效的治疗方法是通过鼻CPAP装置增加空气压力来防止睡眠期间的上呼吸道塌陷;然而，能够监测这种治疗的疗效以及患者依从治疗的能力通常是重要的，有时也是必要的。