SoundTrak: A Data Acquisition and Analysis System for OSDB

SoundTrak：OSDB 数据采集和分析系统

• 批准号: 7611262
• 负责人: B EUGENE PARKER
• 金额: $ 19.92万
• 依托单位: BARRON ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-10 至 2012-06-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7611262
• 关键词: Adult; Agreement; Air Conditioning; Airway Resistance; Apnea; Breathing; Cardiovascular system; Chest; Child; Complex; Data; Diagnosis; Diagnostic; Environment; Environmental air flow; Esophageal; Event; Fingers; Frequencies; Goals; Habits; Heating; Home environment; Individual; Laboratories; Manometry; Measurement; Measures; Medicare; Methods; Monitor; Morbidity - disease rate; Movement; Neurocognitive; Noise; Outcome; Oxygen saturation measurement; Oxyhemoglobin; Patients; Phase I Clinical Trials; Physicians; Physics; Physiologic pulse; Polysomnography; Procedures; Research; Resistance; Siblings; Sleep; Sleep Apnea Syndromes; Snoring; Source; Syndrome; System; Systems Analysis; Time; Universities; Virginia; Wireless Technology; Work; Wrist; base; cost; data acquisition; esophagus pressure; indexing; instrument; neurobehavioral; prototype; public health relevance; sound; sound frequency

DESCRIPTION (provided by applicant): Obstructive sleep-disordered breathing (OSDB) is common in children and is now recognized as having substantial neurocognitive, neurobehavioral, and cardiovascular consequences. There are major limitations in diagnosing OSDB in children, who often do not have discrete apneas or hypopneas that can be diagnosed by measurement of airflow. Instead, children often have long periods with high-resistance breathing where they generate very-low esophageal pressure swings to maintain airflow in the presence of a narrowed airway. Esophageal pressure (Pes) recording is the definitive method to diagnose OSDB, but this measurement is invasive and not widely available. Even without Pes, laboratory polysomnography (PSG) is a complex, burdensome, and costly procedure. Work by two University of Virginia (UVA) physicians, who are part of the proposing team, demonstrated that: (1) high-frequency inspiratory sounds (HFIS) in the frequency range of 2-10 kHz are a marker for the occurrence of OSDB in children; and (2) children generate HFIS when they have a narrowed upper airway during sleep, in which case their upper airway acts as a resonating chamber, completely in agreement with the physics of sound resonance in a cylindrical pipe. It is important to emphasize that these HFIS are different from the low-frequency (< 2 kHz) sounds that describe snoring in adults. Barron Associates and UVA propose to develop the SoundTrak system, a low-cost sleep monitor for use in individuals' home environments to noninvasively and ergonomically acquire and analyze HFIS data pertaining to OSDB. The SoundTrak system will unobtrusively collect low- and high-frequency sound data via a microphone and a small portable PC base station. Breathing movements will be measured using a wireless thoracic band, enabling inspirations to be detected and the patient's sleep sounds to be discriminated from other sources (e.g., a sibling sleeping in the same room, noise from heating, ventilation, and air conditioning systems, etc). Additionally, a commercial wireless wrist-worn finger oximetry system will be included in the Phase I study to investigate the issue of adequacy of ventilation during HFIS events, which can occur with or without oxyhemoglobin desaturation. When HFIS events occur without desaturation, they are frequently not detected by PSG since, in this case, airflow is adequate to maintain ventilation and oxygenation; this is often referred to as the upper airway resistance syndrome (UARS). Being able to distinguish HFIS events with and without desaturation will provide a simple noninvasive method to study whether these events contribute to morbidity in OSDB. Prior studies looking at outcomes for OSDB have been unable to detect the UARS without use of Pes. Recent work by the proposing team demonstrated the feasibility of using HFIS and thoracic monitoring in the sleep laboratory as an alternative to polysomnography for diagnosing OSDB. The central goal of the proposed effort is to demonstrate the viability of in-home HFIS studies in children who are suspected of having OSDB. In particular, traditional overnight laboratory polysomnography, augmented to include esophageal manometry and/or pulse transit time measurement, will be compared with multi-night in-home sleep studies based on an easy-to-use prototype SoundTrak system, and their agreement with respect to a diagnosis of OSDB assessed. PUBLIC HEALTH RELEVANCE: Products resulting from this research have strong potential to provide a more accurate and cost-effective alternative to traditional polysomnography studies performed in sleep laboratories worldwide. Polysomnography may also fail to reproduce patients' usual sleep habits, since the patient is in a new environment and is highly instrumented; as such, home studies using the SoundTrak system are likely to be found to provide more representative data for diagnosing OSDB. Medicare recently announced that it will cover in-home sleep diagnostics, including those using the apnea/hypopnea index as their main criterion. This decision underscores the relevance of the project and the viability of the marketplace.

描述（由申请人提供）：阻塞性睡眠呼吸障碍 (OSDB) 在儿童中很常见，现在被认为具有严重的神经认知、神经行为和心血管后果。儿童 OSDB 的诊断存在重大局限性，儿童通常没有可通过测量气流来诊断的离散呼吸暂停或呼吸不足。相反，儿童通常会长时间处于高阻力呼吸，在气道狭窄的情况下，他们会产生非常低的食道压力波动以维持气流。食管压力 (Pes) 记录是诊断 OSDB 的决定性方法，但这种测量是侵入性的，并未广泛应用。即使没有 Pes，实验室多导睡眠图 (PSG) 也是一个复杂、繁琐且昂贵的过程。提案小组的两名弗吉尼亚大学 (UVA) 医生的研究表明：(1) 2-10 kHz 频率范围内的高频吸气音 (HFIS) 是儿童发生 OSDB 的标志； (2) 儿童在睡眠期间上气道变窄时会产生 HFIS，在这种情况下，他们的上气道充当共振室，完全符合圆柱形管道中声音共振的物理原理。需要强调的是，这些 HFIS 与描述成人打鼾的低频（< 2 kHz）声音不同。 Barron Associates 和 UVA 提议开发 SoundTrak 系统，这是一种低成本睡眠监测器，用于个人家庭环境，以无创且符合人体工程学的方式采集和分析与 OSDB 相关的 HFIS 数据。 SoundTrak 系统将通过麦克风和小型便携式 PC 基站悄悄地收集低频和高频声音数据。将使用无线胸带测量呼吸运动，从而能够检测吸气并将患者的睡眠声音与其他来源（例如，睡在同一房间的兄弟姐妹、来自供暖、通风和空调系统的噪音等）区分开来。此外，商业无线腕戴式手指血氧测定系统将被纳入第一阶段研究中，以调查 HFIS 事件期间通气充足的问题，无论有或没有氧合血红蛋白去饱和，都可能发生。当 HFIS 事件发生而没有饱和度降低时，PSG 通常无法检测到它们，因为在这种情况下，气流足以维持通气和氧合；这通常被称为上气道阻力综合征（UARS）。能够区分有和没有去饱和的 HFIS 事件将提供一种简单的非侵入性方法来研究这些事件是否会导致 OSDB 的发病率。先前针对 OSDB 结果的研究无法在不使用 Pes 的情况下检测 UARS。提议团队最近的工作证明了在睡眠实验室中使用 HFIS 和胸部监测作为多导睡眠图的替代方法来诊断 OSDB 的可行性。拟议工作的中心目标是证明对疑似患有 OSDB 的儿童进行家庭 HFIS 研究的可行性。特别是，传统的夜间实验室多导睡眠监测（增强包括食管测压和/或脉搏传导时间测量）将与基于易于使用的 SoundTrak 原型系统的多晚家庭睡眠研究进行比较，并评估它们在 OSDB 诊断方面的一致性。公共健康相关性：这项研究产生的产品具有强大的潜力，可以为全球睡眠实验室进行的传统多导睡眠图研究提供更准确、更具成本效益的替代方案。多导睡眠图也可能无法重现患者通常的睡眠习惯，因为患者处于新的环境中并且仪器仪表化程度很高；因此，使用 SoundTrak 系统的家庭研究可能会为诊断 OSDB 提供更具代表性的数据。医疗保险最近宣布，它将涵盖家庭睡眠诊断，包括使用呼吸暂停/呼吸不足指数作为主要标准的诊断。这一决定强调了该项目的相关性和市场的可行性。