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）：阻塞性睡眠呼吸呼吸（OSDB）在儿童中很常见，现在被认为具有实质性神经认知，神经行为和心血管后果。诊断儿童OSDB存在主要局限性，他们通常没有离散的apneas或hypopneas，可以通过测量气流来诊断。取而代之的是，儿童通常有很长的时间，高抗性呼吸，在狭窄的气道存在下，他们会产生非常低的食管压力波动以保持气流。食道压力（PES）记录是诊断OSDB的确定方法，但是该测量是侵入性的，并且不可广泛。即使没有PES，实验室多个学位学（PSG）也是一个复杂，繁重且昂贵的程序。弗吉尼亚大学（UVA）的两名医生的工作，是提议团队的一员，证明：（1）在2-10 kHz的频率范围内高频灵感声音（HFIS）是儿童OSDB发生的标志； （2）儿童在睡眠期间有狭窄的上呼吸道时会产生HFI，在这种情况下，他们的上呼吸道充当共鸣室，完全与圆柱管中的声音共振物理学一致。重要的是要强调，这些HFI与描述成人打s的低频（<2 kHz）不同。 Barron Associates和UVA建议开发配乐系统，这是一种低成本睡眠监视器，用于在个人家庭环境中使用，以非侵入性和人体工程学地获取和分析与OSDB有关的HFIS数据。配乐系统将通过麦克风和小型便携式PC基站收集低频和高频声音数据。呼吸运动将使用无线胸带来测量，从而可以检测到灵感，并且患者的睡眠声音与其他来源（例如，在同一房间中睡觉的同胞睡觉，加热，通风和空调系统的噪音等）歧视。此外，第一阶段研究中将包括商业无线手指的血氧仪系统，以调查HFIS事件期间通风是否足够的问题，这可能在有或没有氧气血红蛋白降温的情况下发生。当HFIS事件发生不饱和时，PSG通常不会检测到它们，因为在这种情况下，气流足以维持通风和氧合。这通常称为上呼吸道抗性综合征（UARS）。能够区分有或没有去饱和的HFIS事件将提供一种简单的无创方法，以研究这些事件是否有助于OSDB的发病率。先前研究OSDB结果的研究无法在不使用PE的情况下检测到UARS。提议团队的最新工作表明，在睡眠实验室中使用HFI和胸腔监测的可行性是诊断OSDB的多症术的替代性。拟议的努力的核心目的是证明涉嫌患有OSDB的儿童中HFIS研究的可行性。尤其是，将传统的隔夜实验室多摄影术增强，包括食管测量和/或脉冲传输时间测量，将与基于易于使用的原型原型配乐系统的多晚室内睡眠研究进行比较，以及它们在评估OSDB评估的OSDB诊断方面一致。公共卫生相关性：这项研究产生的产品具有强大的潜力，可以为在全球睡眠实验室中进行的传统多聚会研究提供更准确和成本效益的替代方案。由于患者处于新环境状态并且高度仪器，因此多摄影学也可能无法再现患者通常的睡眠习惯。因此，可能会发现使用配乐系统的家庭研究可以提供更多代表性的数据来​​诊断OSDB。 Medicare最近宣布，它将涵盖家庭睡眠诊断，包括使用呼吸暂停/呼吸呼吸症指数作为其主要标准的诊断。该决定强调了项目的相关性和市场的可行性。