A multi-sensor catheter for diagnosing obstructive sleep apnea

用于诊断阻塞性睡眠呼吸暂停的多传感器导管

• 批准号: 10696658
• 负责人: Jose Luis Bohorquez
• 金额: $ 29.97万
• 依托单位: BOLD TYPE LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10696658
• 关键词: Acoustics; Adult; Affect; Algorithms; Anatomy; Anesthesia procedures; Anterior; Board Certification; Breathing; Carbon Dioxide; Catheters; Data; Databases; Devices; Diagnosis; Diagnostic tests; Diameter; Disease; Endoscopy; Ensure; Esophagus; Evaluation; Licensing; Location; Measurement; Measures; Medical; Medical Device; Nasopharynx; Nature; Obstruction; Obstructive Sleep Apnea; Oropharyngeal; Otolaryngologist; Patients; Pattern; Performance; Persons; Pharmaceutical Preparations; Pharyngeal structure; Phase; Physiology; Polysomnography; Positioning Attribute; Propofol; Public Health; Radio; Regulation; Regulatory Affairs; Research Personnel; Resources; Roentgen Rays; Role; Safety; Sedation procedure; Selection for Treatments; Sensitivity and Specificity; Severities; Silicone Elastomers; Site; Sleep; Small Business Innovation Research Grant; Source; Specific qualifier value; Supine Position; System; Tablets; Testing; Time; Training; Tube; Variant; Ventilator; Visual; airway obstruction; cloud storage; commercialization readiness; comorbidity; compliance behavior; cost; data exchange; design; diagnostic algorithm; experience; human data; human study; hypopharynx; innovation; instrument; mortality; portability; power analysis; pressure; pressure sensor; product development; prototype; recruit; sensor; software development; success; transmission process; visual feedback; vocalization; wireless; wireless communication

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.

项目概要 很少有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 仅在美国就有超过 2000 万人，如果不治疗，会导致严重的合并症 和死亡率。然而，目前的 OSA 诊断测试价格昂贵、不方便且基本上无效。 隔夜设施内睡眠研究（也称为多导睡眠图 (PSG)）显示患者依从性较低，并且 敏感性和特异性有限，很大程度上是由于 OSA 的解剖结构复杂性。药物引起的睡眠 内窥镜检查 (DISE) 可以提供有关阻塞类型和位置的附加信息，但需要直接 训练有素的耳鼻喉科医生和麻醉专业人员的参与。此外，其可靠性也受到限制 调查结果的主观性质。简而言之，一种安全、便携、高效的快速仪器 阻塞性气道生理学特征将广泛用于评估患有以下疾病的患者 疑似阻塞性睡眠呼吸暂停。该系统将通过提供关键信息使数百万患者受益 帮助确定特定患者 OSA 的最佳治疗方法。我们相信，多传感器 我们提出的导管系统可以起到这个作用。 Bold Type 正在开发“SmartCatheter”系统，这是一种无线、云连接、多传感器导管和 平板电脑应用程序旨在快速评估上呼吸道阻塞，以诊断阻塞性睡眠呼吸暂停 （OSA）。我们假设：（1）一种用于测量和分析声学和压力的创新系统 上呼吸道可以发育； (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； (3) 可以开发算法来转换原始数据 将声学和压力数据转化为汇总指标，有助于诊断阻塞性睡眠呼吸暂停。我们 提出以下具体目标： 在目标 1 中，我们将开发一个由无线、 鼻食管多传感器导管，用于记录沿上部的动态声压和静压 气道和与导管无线通信的平板电脑应用程序，对声学和 压力波形，向用户提供视觉反馈，并将数据传输到数据库进行存储和 分析。在目标 2 中，我们将开发能够检测存在、位置、 气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 使用目标 1 中开发的系统对 5 名健康对照者和 5 名 OSA 患者进行人体研究，收集数据 初步的人体数据并评估两组之间的声学​​和压力差异。之上 成功完成这三个目标，我们将做好准备开展第二阶段 SBIR 项目 致力于开发商业化的 SmartCatheter 系统并在多站点研究中对其进行验证 与 PSG 和 DISE 进行性能比较。