A multi-sensor catheter for diagnosing obstructive sleep apnea

项目摘要 很少有医学疾病比阻塞性睡眠呼吸暂停(OSA)对公共健康的影响更大。OSA影响 仅在美国就有2000多万人，如果不治疗，它会导致严重的合并症 和死亡率。然而，目前对OSA的诊断测试昂贵、不方便，而且很大程度上无效。 夜间设施内睡眠研究，也被称为多导睡眠图(PSG)，显示患者依从性低和 敏感性和特异性有限，主要是由于阻塞性睡眠呼吸暂停综合征解剖结构的复杂性。药物性睡眠 内窥镜检查(DISE)可以提供有关梗阻类型和位置的其他信息，但它需要直接 由训练有素的耳鼻喉科医生和麻醉专业人员参与。此外，它的可靠性也是有限的 调查结果的主观性。简而言之，一种安全、便携和高效的快速 阻塞性呼吸道生理学特征将被广泛用于评估患者 疑似阻塞性睡眠呼吸暂停。这一系统将通过提供关键信息使数百万患者受益 以帮助确定特定患者OSA的最佳治疗方法。我们认为多传感器 我们提出的导管系统可以起到这一作用。 BOLD Type正在开发“智能导管”系统，这是一种无线的、云连接的多传感器导管和 平板电脑应用程序旨在提供对上呼吸道阻塞的快速评估以诊断阻塞性睡眠呼吸暂停 (OSA)。我们假设：(1)一种用于沿线测量和分析声学和压力的创新系统 可以开发上呼吸道；(2)来自声学和压力传感器的组合数据将是敏感的 障碍物的存在、位置、类型和程度；以及(3)可以开发算法来转换RAW 将声学和压力数据转换为便于诊断阻塞性睡眠呼吸暂停的摘要指标。我们 提出以下具体目标：在目标1中，我们将开发一种由无线、 经鼻-食道多传感器导管记录上端动态声压和静压 和平板电脑应用程序，可以与导管进行无线通信，对声学和 压力波形，为用户提供可视反馈，并将数据传输到数据库以存储和 分析。在目标2中，我们将开发能够检测存在、位置、 呼吸道模拟器中的阻塞类型和程度。在目标3中，我们将进行有限的概念验证 使用AIM 1中开发的系统进行的人体研究，收集了5名健康对照和5名OSA患者 初步人体数据，并评估两组之间的声学和压力差异。vt.在.的基础上 成功完成这三个目标，我们将做好准备，进行第二阶段的SBIR项目 开发可商业化的智能导管系统并在多点研究中验证 将性能与PSG和DISE进行比较。

Project Summary Few medical disorders have a larger public health impact than Obstructive Sleep Apnea (OSA). OSA affects more than 20 million people in the US alone, and when untreated, it is associated with significant comorbidities and mortality. Current diagnostic tests for OSA, however, are expensive, inconvenient, and largely ineffective. Overnight in-facility sleep studies, also known as polysomnography (PSG), show low patient compliance and limited sensitivity and specificity, largely due to the anatomical complexity of OSA. Drug-induced sleep endoscopy (DISE) can provide additional information on the type and location of obstruction, but it requires direct involvement of a trained otolaryngologist and anesthesia professional. Furthermore, its reliability is limited due to the subjective nature of the findings. In short, a safe, portable, and efficient instrument for rapid characterization of obstructive airway physiology would find wide use in the assessment of patients with suspected obstructive sleep apnea. This system would benefit millions of patients by providing critical information to aid in the determination of the best therapy for OSA in a particular patient. We believe that the multi-sensor catheter system we are proposing can serve this role. Bold Type is developing the “SmartCatheter” system, a wireless, cloud-connected, multi-sensor catheter and tablet app designed to provide rapid evaluation of upper airway obstruction to diagnose obstructive sleep apnea (OSA). We hypothesize that: (1) an innovative system for measuring and analyzing acoustic and pressure along the upper airway can be developed; (2) that combined data from acoustic and pressure sensors will be sensitive to obstruction presence, location, type, and degree; and (3) that algorithms can be developed to convert raw acoustic and pressure data into summary metrics that facilitate the diagnosis of obstructive sleep apnea. We propose the following Specific Aims: In Aim 1, we will develop a SmartCatheter system composed of a wireless, naso-esophageal multi-sensor catheter to record dynamic acoustic pressure and static pressure along the upper airway, and a tablet app to communicates wirelessly with the catheter, perform algorithms on acoustic and pressure waveforms, provide visual feedback to the user, and transfer data to a database for storage and analysis. In Aim 2, we will develop preliminary diagnostic algorithms capable of detecting the presence, location, type, and degree of obstruction in an airway simulator. And in Aim 3, we will conduct a limited proof-of-concept human study using the system developed in Aim 1 with 5 healthy controls and 5 OSA patients to gather preliminary human data and evaluate acoustic and pressure differences between the two groups. Upon successful completion of these three aims, we will be well poised to pursue a Phase 2 SBIR project geared toward developing a commercialization ready SmartCatheter system and validating it in a multi-site study comparing performance against PSG and DISE.