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.

项目摘要 很少有医学疾病比阻塞性睡眠呼吸暂停（OSA）对公众健康的影响更大。OSA影响 仅在美国就有超过2000万人，如果不治疗，它与严重的合并症有关。 and mortality.然而，目前用于OSA的诊断测试是昂贵的、不方便的并且在很大程度上是无效的。 夜间设施内睡眠研究，也称为多导睡眠图（PSG），显示患者依从性低， 有限的灵敏度和特异性，主要是由于OSA的解剖复杂性。药物诱导睡眠 内窥镜检查（DISE）可以提供关于梗阻类型和位置的额外信息，但需要直接 由一名训练有素的耳鼻喉科医生和麻醉专业人员参与。此外，其可靠性有限， 调查结果的主观性总之，一种安全、便携、高效的快速检测仪器， 阻塞性气道生理学的表征将广泛用于评估 疑似阻塞性睡眠呼吸暂停该系统将通过提供关键信息而使数百万患者受益 以帮助确定特定患者中OSA的最佳疗法。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， 平板电脑应用程序，旨在提供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）一个创新的系统，用于测量和分析声学和压力沿着 上气道可以被开发;（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）可以开发算法来将原始的 将声学和压力数据转化为汇总指标，以促进阻塞性睡眠呼吸暂停的诊断。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， 鼻食管多传感器导管，以记录沿上沿着的动态声压和静压 气道和平板电脑应用程序与导管进行无线通信，执行声学算法， 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， 分析.在目标2中，我们将开发初步的诊断算法，能够检测存在，位置， 类型和气道模拟器中的阻塞程度。在目标3中，我们将进行有限的概念验证， 使用在Aim 1中开发的系统的人类研究，其中5名健康对照和5名OSA患者收集 初步的人类数据，并评估两组之间的声学和压力差异。后 在成功完成这三个目标后，我们将做好准备，继续进行SBIR第二阶段项目， 旨在开发商业化就绪的SmartCatheter系统并在多中心研究中对其进行验证 比较PSG和DISE的性能。