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)患者呼吸道阻塞位置的能力对于外科和口腔器械治疗至关重要，因为这些治疗方法的目标是操纵或移除特定的可折叠口咽区。然而，到目前为止，还没有足够的工具可以准确和方便地定位坍塌地点。目前的方法要么不准确，要么具有侵入性，将导管长时间放置在咽部深处，使这些研究不舒服和不受欢迎。我们建议开发一种易于应用的、可以在夜间佩戴的非侵入性设备，它可以首次定位自然睡眠状态下的气道不稳定。拟议的夜间声学咽喉仪(NAP)设备基于声反射原理，可以根据声波到达该障碍物并返回该障碍物所需的时间来确定到该障碍物的距离。该设备由一个嵌入扬声器/麦克风的口罩组成，麦克风连接到睡眠监视器。睡眠监测器将收集声音反射以及患者的睡眠状态，这将使其能够分析有无呼吸道阻塞的声音反射。然后，信号处理将提取由障碍物引起的回波，从而计算到坍塌地点的距离。我们计划使用口腔面罩作为患者界面的基础，因为与狭窄和分叉的鼻腔相比，口腔提供了更有效的声音传输到呼吸道。患者接口将连接到CPAP，以提供口腔呼吸通常所需的加热湿化。我们还将在夜间重复调整CPAP压力，以与CPAP滴定相同的方式，作为提高系统整体精度的一种方法。夜间CPAP滴定期间多次解决呼吸暂停将为NAP提供一个独特的环境，以精确定位特定于障碍物的回声，并提高定位精度。此外，这将使NAP可以很容易地整合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培训，并加快医生的采用速度。本阶段I将专注于开发和测试患者界面，针对此应用程序修改CleveMed睡眠监测器，并在工作台和患者身上进行测试。我们相信，NAP将首次为睡眠社区提供一个重要而方便的补充工具，帮助指导OSA患者的手术或口腔矫治器治疗。公共卫生相关性：确定阻塞性睡眠呼吸暂停(OSA)患者呼吸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纵或移除特定的可折叠口咽区。然而，到目前为止，还没有足够的工具可以准确和方便地定位坍塌地点。目前的方法要么不准确，要么具有侵入性，将导管长时间放置在咽部深处，使这些研究不舒服和不受欢迎。我们建议开发一种易于应用的、可以在夜间佩戴的非侵入性设备，它可以首次定位自然睡眠状态下的气道不稳定。拟议的夜间声学咽喉仪(NAP)设备基于声反射原理，可以根据声波到达该障碍物并返回该障碍物所需的时间来确定到该障碍物的距离。该设备由一个嵌入扬声器/麦克风的口罩组成，麦克风连接到睡眠监视器。睡眠监测器将收集声音反射以及患者的睡眠状态，这将使其能够分析有无呼吸道阻塞的声音反射。然后，信号处理将提取由障碍物引起的回波，从而计算到坍塌地点的距离。我们计划使用口腔面罩作为患者界面的基础，因为与狭窄和分叉的鼻腔相比，口腔提供了更有效的声音传输到呼吸道。患者接口将连接到CPAP，以提供口腔呼吸通常所需的加热湿化。我们还将在夜间重复调整CPAP压力，以与CPAP滴定相同的方式，作为提高系统整体精度的一种方法。夜间CPAP滴定期间多次解决呼吸暂停将为NAP提供一个独特的环境，以精确定位特定于障碍物的回声，并提高定位精度。此外，这将使NAP可以很容易地整合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培训，并加快医生的采用速度。本阶段I将专注于开发和测试患者界面，针对此应用程序修改CleveMed睡眠监测器，并在工作台和患者身上进行测试。我们相信，NAP将首次为睡眠社区提供一个重要而方便的补充工具，帮助指导OSA患者的手术或口腔矫治器治疗。

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.