Tympanometric laser Doppler vibrometry measurements of middle ear function

鼓室导抗激光多普勒振动测量中耳功能

• 批准号: 9922131
• 负责人: Martin Patrick Feeney
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9922131
• 关键词: 3D Print; Acoustics; Air Pressure; Area; Audiology; Clinic; Clinical; Clinical Trials; Computers; Control Groups; Custom; Data; Data Collection; Diagnosis; Diagnostic; Diagnostic Sensitivity; Disease; Ear; Emerging Technologies; Enrollment; Evaluation; External auditory canal; Frequencies; Gaussian model; Goals; Grant Review; Healthcare Systems; Hearing; Hearing Tests; Hour; Individual; Lasers; Malleus; Masks; Measurement; Measures; Modeling; Movement; Otolaryngologist; Otosclerosis; Outcome Study; Pathology; Patients; Physiological; Positioning Attribute; Process; Publishing; Pump; Rehabilitation Centers; Research; Sampling; Sensorineural Hearing Loss; Speculums; Stapes; Stimulus; System; Tail; Techniques; Technology; Testing; Tympanic membrane; Tympanometry; United States National Institutes of Health; Veterans; Visit; Work; auditory rehabilitation; base; bone; data acquisition; data warehouse; hearing impairment; improved; middle ear; middle ear disorder; normal hearing; pressure; recruit; sample fixation; sound; tool; vibration

Laser Doppler vibrometry (LDV) is an emerging technology for assessing middle ear (ME) function that detects the sound-induced velocity (Vu) of one of the ME bones, the malleus, over a wide frequency range (300 to 6000 Hz) using a reflected laser beam. The PI seeks to develop LDV measures as a new research area in line with his previous work in the assessment of ME function using wideband acoustic immittance (WAI) measurements. Because LDV measures the movement of one of the ossicles, it is inherently sensitive to ossicular chain disorders such as otosclerosis, and is thus a potentially useful diagnostic tool. LDV obtained at ambient pressure in the ear canal has been shown to result in similar diagnostic sensitivity to WAI, but has wide variability. The diagnostic capability of LDV may be enhanced by making measurements at tympanometric peak pressure (TPP) rather than ambient pressure to control for the effects of varying middle- ear pressure from test to retest and across subjects. This ME pressure related variability may mask underlying ME disorders. Moreover, a comparison of Vu at TPP with tympanometric tail pressures (e.g. ±200 daPa) may provide additional information about the ME status that previously has not been measured. This will be the first study to evaluate the use of tympanometric (varying ear canal pressure) LDV measures for the assessment of ME function. Aim 1 is to make the first repeated measures of Vu at TPP and tympanometric tail pressures in control subjects with normal ME function using a custom ear speculum developed at the VA National Center for Rehabilitative Auditory Research (NCRAR). These test-retest differences will be compared with measurements obtained at ambient pressure by fitting a hierarchical Gaussian process regression model to these data, as well as comparing the data to published test-retest differences for Vu at ambient pressure. Aim 2, using the data from Aim 1, will establish reference limits as a function of frequency for ambient pressure, TPP, ±100 daPa, and ±200 daPa, and for tympanometric peak-to-tail differences for ±100 daPa and ±200 daPa. In Aim 3 the reference limits established in Aim 2 will be applied to the Vu data obtained from 10 subjects with a diagnosis of otosclerosis for ambient pressure and pressurized measures. A Bayesian hierarchical regression model will be used to compare mean differences in Vu between the control group and the otosclerosis group at each of the 9 stimulus frequencies in each test condition. Subjects will be recruited using the NCRAR data repository, through approved flyers posted in the VA Portland Health Care System (VAPORHCS) and handouts provided to patients from audiologists or otolaryngologists in VAPORHCS clinics. Enrollment in the study is for two study visits for both control subjects and those with otosclerosis: The first visit involves hearing evaluation and tympanometry as well as measurements of LDV for both ears at ambient pressure, tympanometric peak pressure determined by 226 Hz tympanometry, and for tympanometric tail pressures at ±100 and ±200 daPa. At the second study visit approximately one month later all tests will be repeated. Based on preliminary data collection, we anticipate that each visit will last approximately 2 hours. Subjects will be tested in a sound-treated booth for all tests. A clinical audiometer will be used for hearing tests followed by tympanometry using a clinical tympanometer. LDV measurements will be completed with a Polytec OFV 534 laser vibrometer. Two research audiologists are required for each measurement: one to position the speculum and manipulate the laser, and the second to assist in computer data acquisition. Air pressure will be varied using the pressure pump from the tympanometer connected to the custom speculum with standard tubing to make measurements at TPP and ±100 and ±200 daPa. The study outcomes will inform the specific aims for a VA Merit Review or NIH R01 study to compare ambient and tympanometric LDV in the assessment of various ME disorders with the long- term goal of moving to a clinical trial of this technology for Veterans with ME disorders.

激光多普勒振动测量 (LDV) 是一种用于评估中耳 (ME) 功能的新兴技术， 在很宽的频率范围内检测 ME 骨之一（锤骨）的声感应速度 (Vu) （300 至 6000 Hz）使用反射激光束。 PI 寻求将 LDV 衡量标准作为一项新研究 与他之前使用宽带声导抗 (WAI) 评估 ME 功能的工作一致 测量。由于 LDV 测量其中一个小骨的运动，因此它本质上对 听骨链疾病，例如耳硬化症，因此是一种潜在有用的诊断工具。 LDV 获得于 耳道内的环境压力已被证明会导致与 WAI 类似的诊断敏感性，但 广泛的可变性。 LDV 的诊断能力可以通过在以下位置进行测量来增强： 鼓室导抗峰值压力（TPP）而不是环境压力来控制不同中压的影响 从测试到重新测试以及跨受试者的耳压。这种与 ME 压力相关的变化可能会掩盖潜在的 ME 疾病。此外，TPP 处的 Vu 与鼓室导抗尾部压力（例如 ±200 daPa）的比较可能会 提供有关先前未测量的 ME 状态的附加信息。这将是第一个 研究评估使用鼓室导抗（变化的耳道压力）LDV 测量来评估 我的功能。目标 1 是首次重复测量 TPP 下的 Vu 和鼓室导抗尾压 使用 VA 国家中心开发的定制耳镜控制具有正常 ME 功能的受试者 康复听觉研究（NCRAR）。这些重测差异将与 通过将分层高斯过程回归模型拟合到环境压力下获得的测量值 这些数据，以及将这些数据与已发布的环境压力下 Vu 的重测差异进行比较。目的 2，使用目标 1 中的数据，将建立作为环境压力频率函数的参考限值， TPP、±100 daPa 和 ±200 daPa，以及 ±100 daPa 和 ±200 的鼓室导抗峰尾差异 达帕。在目标 3 中，目标 2 中建立的参考限值将应用于从 10 中获得的 Vu 数据 因环境压力和加压措施而诊断为耳硬化症的受试者。贝叶斯 分层回归模型将用于比较对照组和对照组之间 Vu 的平均差异。 耳硬化症组在每个测试条件下的 9 个刺激频率中的每一个。 将通过在 VA 上张贴批准的传单，使用 NCRAR 数据存储库招募受试者 波特兰医疗保健系统 (VAPORHCS) 以及听力学家或听力学家向患者提供的讲义 VAPORHCS 诊所的耳鼻喉科医生。研究的注册是针对两个对照受试者的两次研究访问 患有耳硬化症的患者：首次就诊包括听力评估和鼓室导抗测试以及 在环境压力下测量双耳 LDV，鼓室导抗峰值压力由 226 Hz 确定 鼓室导抗测试，以及 ±100 和 ±200 daPa 的鼓室导抗尾部压力。第二次考察访问时 大约一个月后，所有测试将重复进行。根据初步收集的数据，我们预计 每次参观将持续约2小时。所有测试的受试者都将在隔音室中接受测试。一个 将使用临床听力计进行听力测试，然后使用临床鼓室计进行鼓室测试。 LDV 测量将使用 Polytec OFV 534 激光振动计完成。两位研究听力学家是 每次测量都需要：一个用于定位窥器并操纵激光，第二个用于 协助计算机数据采集。气压将通过来自压力泵的改变 鼓室压力计通过标准管连接到定制窥器，以在 TPP 和 ±100 和 ±200 daPa。研究结果将为 VA Merit Review 或 NIH R01 的具体目标提供信息 比较环境和鼓室导抗 LDV 在评估各种 ME 疾病中的作用与长期研究 短期目标是针对患有 ME 疾病的退伍军人进行这项技术的临床试验。