Nighttime Acoustic Pharyngometer (NAP) for Airway Obstruction Identification

描述（由申请人提供）：确定阻塞性睡眠呼吸暂停（OSA）患者气道阻塞位置的能力对于外科和口腔器械治疗至关重要，因为这些治疗针对特定可折叠口咽区域的操作或去除。然而，到目前为止，还没有足够的工具可以准确方便地定位坍塌地点。目前的方法要么是不准确的，要么是侵入性的，因为导管被长时间放置在咽部深处，这使得这些研究不舒服和不受欢迎。我们建议开发一种易于使用的非侵入性装置，可以在夜间佩戴，首次可以在自然睡眠状态下定位气道不稳定。这个被提议的夜间声学咽计（NAP）装置是基于声反射原理，即声波到达障碍物并返回所需的时间可以确定到障碍物的距离。该设备由一个嵌入扬声器/麦克风的口腔面罩和一个睡眠监测器组成。睡眠监测器将收集声音反射以及患者的睡眠状态，这将允许它分析有或没有气道阻塞的声音反射。然后，信号处理将提取由障碍物引起的回波，从而计算到崩溃点的距离。我们计划使用口腔口罩作为患者界面的基础，因为与狭窄的分叉鼻道相比，口腔可以更有效地将声音传递到气道中。患者接口将连接到CPAP，以提供口腔呼吸所需的加热加湿。我们还将在夜间反复调整CPAP压力，以与CPAP滴定相同的方式，作为提高整体系统准确性的方法。在夜间多次CPAP滴定过程中，呼吸暂停的分辨率将为NAP提供一个独特的环境来确定障碍物特定的回声并提高定位精度。此外，这将使NAP很容易集成到标准的睡眠实验室操作中，这将最大限度地减少技术人员的培训，并加快医生的采用。第一阶段将专注于开发和测试患者界面，为该应用修改cleevemed睡眠监测仪，并在实验台上和患者身上进行测试。我们相信NAP将首次为睡眠界提供一个重要而方便的辅助工具，以帮助直接对OSA患者进行手术或口腔器械治疗。公共卫生相关性：确定阻塞性睡眠呼吸暂停（OSA）患者气道阻塞位置的能力对于外科和口腔器械治疗至关重要，因为这些治疗的目标是操作或去除特定的可折叠口咽区域。然而，到目前为止，还没有足够的工具可以准确方便地定位坍塌地点。目前的方法要么是不准确的，要么是侵入性的，因为导管被长时间放置在咽部深处，这使得这些研究不舒服和不受欢迎。我们建议开发一种易于使用的非侵入性装置，可以在夜间佩戴，首次可以在自然睡眠状态下定位气道不稳定。这个被提议的夜间声学咽计（NAP）装置是基于声反射原理，即声波到达障碍物并返回所需的时间可以确定到障碍物的距离。该设备由一个嵌入扬声器/麦克风的口腔面罩和一个睡眠监测器组成。睡眠监测器将收集声音反射以及患者的睡眠状态，这将允许它分析有或没有气道阻塞的声音反射。然后，信号处理将提取由障碍物引起的回波，从而计算到崩溃点的距离。我们计划使用口腔口罩作为患者界面的基础，因为与狭窄的分叉鼻道相比，口腔可以更有效地将声音传递到气道中。患者接口将连接到CPAP，以提供口腔呼吸所需的加热加湿。我们还将在夜间反复调整CPAP压力，以与CPAP滴定相同的方式，作为提高整体系统准确性的方法。在夜间多次CPAP滴定过程中，呼吸暂停的分辨率将为NAP提供一个独特的环境来确定障碍物特定的回声并提高定位精度。此外，这将使NAP很容易集成到标准的睡眠实验室操作中，这将最大限度地减少技术人员的培训，并加快医生的采用。第一阶段将专注于开发和测试患者界面，为该应用修改cleevemed睡眠监测仪，并在实验台上和患者身上进行测试。我们相信NAP将首次为睡眠界提供一个重要而方便的辅助工具，以帮助直接对OSA患者进行手术或口腔器械治疗。

DESCRIPTION (provided by applicant): The ability to define the location of airway obstructions in Obstructive Sleep Apnea (OSA) patients is critical for surgical and oral appliance treatments because these therapies target the manipulation or removal of specific collapsible oropharyngeal regions. Yet, to this date, there are no adequate tools that can accurately and conveniently locate the collapse site. Current methods are either inaccurate or invasive whereby catheters are placed deep in the pharynx for prolonged periods of time making these studies uncomfortable and unpopular. We propose to develop an easy to apply non-invasive device that can be worn during the night, which can localize, for the first time, airway instability in the natural asleep state. The proposed, Nighttime Acoustic Pharyngometer (NAP) device, is based on the principle of acoustic reflectance whereby the distance to an obstruction can be determined from the time it takes a sound wave to travel to that obstruction and back. The device consists of an oral mask embedded with speaker / microphone connected to a sleep monitor. The sleep monitor will collect sound reflections along with the patient's sleep status, which will allow it to analyze sound reflections with and without airway obstructions. Signal processing will then extract those echoes caused by the obstruction and consequently calculate the distance to collapse site. We plan to use an oral mask as the basis for the patient interface because the oral cavity offers a more efficient transfer of sound into the airways when compared to the narrow and bifurcated nasal passage. The patient interface will be connected to a CPAP to provide heated humidification typically required for oral breathing. We will also adjust the CPAP pressure repeatedly during the night, in a manner identical to CPAP titration, as a method to improve overall system accuracy. Resolution of apneas during CPAP titration multiple times during the night will afford NAP a unique environment to pinpoint obstruction-specific echoes and to enhance localization accuracy. Furthermore, this will allow NAP to be easily integrated within the standard sleep laboratory operation, which will minimize technologists training and speed adoption by physicians. This Phase I will focus on developing and testing the patient interface, modify a CleveMed sleep monitor for this application and test on the bench and on patients. We believe NAP will provide the sleep community, for the first time, with an important and convenient complementary tool to help direct surgical or oral appliance treatments for OSA patients. PUBLIC HEALTH RELEVANCE: The ability to define the location of airway obstructions in Obstructive Sleep Apnea (OSA) patients is critical for surgical and oral appliance treatments because these therapies target the manipulation or removal of specific collapsible oropharyngeal regions. Yet, to this date, there are no adequate tools that can accurately and conveniently locate the collapse site. Current methods are either inaccurate or invasive whereby catheters are placed deep in the pharynx for prolonged periods of time making these studies uncomfortable and unpopular. We propose to develop an easy to apply non-invasive device that can be worn during the night, which can localize, for the first time, airway instability in the natural asleep state. The proposed, Nighttime Acoustic Pharyngometer (NAP) device, is based on the principle of acoustic reflectance whereby the distance to an obstruction can be determined from the time it takes a sound wave to travel to that obstruction and back. The device consists of an oral mask embedded with speaker / microphone connected to a sleep monitor. The sleep monitor will collect sound reflections along with the patient's sleep status, which will allow it to analyze sound reflections with and without airway obstructions. Signal processing will then extract those echoes caused by the obstruction and consequently calculate the distance to collapse site. We plan to use an oral mask as the basis for the patient interface because the oral cavity offers a more efficient transfer of sound into the airways when compared to the narrow and bifurcated nasal passage. The patient interface will be connected to a CPAP to provide heated humidification typically required for oral breathing. We will also adjust the CPAP pressure repeatedly during the night, in a manner identical to CPAP titration, as a method to improve overall system accuracy. Resolution of apneas during CPAP titration multiple times during the night will afford NAP a unique environment to pinpoint obstruction-specific echoes and to enhance localization accuracy. Furthermore, this will allow NAP to be easily integrated within the standard sleep laboratory operation, which will minimize technologists training and speed adoption by physicians. This Phase I will focus on developing and testing the patient interface, modify a CleveMed sleep monitor for this application and test on the bench and on patients. We believe NAP will provide the sleep community, for the first time, with an important and convenient complementary tool to help direct surgical or oral appliance treatments for OSA patients.