Nighttime Acoustic Pharyngometer (NAP) for Airway Obstruction Identification

用于识别气道阻塞的夜间声学咽喉计 (NAP)

• 批准号: 7744561
• 负责人: Hani Akram Kayyali
• 金额: $ 25.63万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-28 至 2012-03-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7744561
• 关键词: Acoustics; Adoption; Apnea; Area; Back; Benign; Breathing; Carbon Dioxide; Cardiovascular Diseases; Catheters; Cephalometry; Choking; Communities; Continuous Positive Airway Pressure; Data; Devices; Disease; Effectiveness; Endoscopes; Endoscopy; Environment; Esophageal; Estimation Techniques; Evaluation; Excessive Daytime Sleepiness; Excision; Face; Flaccid Muscle Tone; Functional disorder; Future; Hand; Heart Diseases; Heating; Home environment; Image; Interruption; Intervention; Laboratories; Length; Link; Location; Manikins; Manometry; Masks; Measures; Medical; Methods; Modality; Modeling; Monitor; Nose; Obstruction; Obstructive Sleep Apnea; Operative Surgical Procedures; Oral; Oral Surgical Procedures; Oral cavity; Oropharyngeal; Patients; Pharyngeal structure; Phase; Phenotype; Physicians; Polysomnography; Procedures; Process; Questionnaires; Recommendation; Recruitment Activity; Research; Research Personnel; Resolution; Role; Simulate; Site; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Speed; Stroke; Structure; System; Techniques; Testing; Time; Tissues; Titrations; Training; Translating; Travel; Treatment outcome; United States National Institutes of Health; Upper arm; Visit; X-Ray Computed Tomography; abstracting; airway obstruction; base; computerized data processing; design; falls; improved; novel; pressure; prevent; public health relevance; research clinical testing; seal; sound; success; tool

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.

描述（由申请人提供）：定义气道障碍物在阻塞性睡眠呼吸暂停（OSA）患者中的位置对于手术和口服器具治疗至关重要，因为这些疗法针对的是操纵或去除特定可折叠的口咽区域。然而，到目前为止，还没有足够的工具可以准确，方便地找到倒塌站点。当前的方法是不准确或侵入性的，从而长期将导管置于咽部深处，使这些研究不舒服且不受欢迎。我们建议开发一种易于使用的非侵入性装置，该设备可以在夜间穿着，该设备可以首次定位在天然入睡状态下的气道不稳定。提出的夜间声学咽图（NAP）设备基于声学反射率的原理，在该原理中，可以从声波到达障碍物和后背的声波的时间来确定障碍物的距离。该设备由嵌入到睡眠监视器的扬声器 /麦克风嵌入的口服面膜组成。睡眠监视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或没有气道障碍物的声音反射。然后，信号处理将提取因阻塞引起的回声，并因此计算倒塌部位的距离。我们计划使用口腔掩膜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转移到气道中。患者界面将连接到CPAP，以提供通常需要口腔呼吸的加热加湿化。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带来一个独特的环境，以查明梗阻特异性的回声并提高定位精度。此外，这将使小睡可以轻松地集成到标准的睡眠实验室操作中，这将最大程度地减少技术人员的培训和速度采用。这一阶段我将重点介绍开发和测试患者界面，修改该应用程序的Clevemed睡眠监视器，并在长凳和患者上进行测试。我们认为，NAP将首次为睡眠社区提供一种重要且方便的互补工具，以帮助指导OSA患者的手术或口服器械治疗。公共卫生相关性：定义阻塞性睡眠呼吸暂停（OSA）患者中气道障碍物的位置的能力对于手术和口服器具治疗至关重要，因为这些疗法针对的是操纵或去除特定可折叠的口咽区域。然而，到目前为止，还没有足够的工具可以准确，方便地找到倒塌站点。当前的方法是不准确或侵入性的，从而长期将导管置于咽部深处，使这些研究不舒服且不受欢迎。我们建议开发一种易于使用的非侵入性装置，该设备可以在夜间穿着，该设备可以首次定位在天然入睡状态下的气道不稳定。提出的夜间声学咽图（NAP）设备基于声学反射率的原理，在该原理中，可以从声波到达障碍物和后背的声波的时间来确定障碍物的距离。该设备由嵌入到睡眠监视器的扬声器 /麦克风嵌入的口服面膜组成。睡眠监视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或没有气道障碍物的声音反射。然后，信号处理将提取因阻塞引起的回声，并因此计算倒塌部位的距离。我们计划使用口腔掩膜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转移到气道中。患者界面将连接到CPAP，以提供通常需要口腔呼吸的加热加湿化。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带来一个独特的环境，以查明梗阻特异性的回声并提高定位精度。此外，这将使小睡可以轻松地集成到标准的睡眠实验室操作中，这将最大程度地减少技术人员的培训和速度采用。这一阶段我将重点介绍开发和测试患者界面，修改该应用程序的Clevemed睡眠监视器，并在长凳和患者上进行测试。我们认为，NAP将首次为睡眠社区提供一种重要且方便的互补工具，以帮助指导OSA患者的手术或口服器械治疗。