Novel Test of Infant Hearing

婴儿听力的新颖测试

• 批准号: 10082255
• 负责人: Avinash D Singh
• 金额: $ 25.04万
• 依托单位: PERCEPTIVO, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10082255
• 关键词: Adult; Age; Algorithms; Animals; Audiology; Auditory; Auditory Brainstem Responses; Biological Assay; Childhood; Clinic; Clinical; Computer software; Consumption; Data; Databases; Detection; Development; Diagnosis; Diagnostic Procedure; Diagnostic tests; Discrimination; Early Diagnosis; Early Intervention; Early identification; Electrodes; Ensure; Esthesia; Evaluation; Exhibits; Eye; Feedback; Funding; Goals; Gold; Guidelines; Head; Hearing; Hearing Tests; Infant; Intervention; Language; Language Delays; Language Development; Legal patent; Life; Measures; Methodology; Methods; Movement; Mydriasis; Neonatal Screening; Nervous system structure; Neurocognitive; Optics; Output; Pathologic; Pediatric Hospitals; Performance; Phase; Physiological; Process; Production; Pupil; Risk Factors; Sedation procedure; Sleep; Small Business Innovation Research Grant; Speech; Speech Development; Speed; Stimulus; Surveys; System; Techniques; Testing; Time; Training; Validation; age group; animation; auditory pathway; base; behavior test; blind; clinical application; commercialization; developmental disease; experience; gaze; hearing impairment; innovation; meetings; normal hearing; novel; operation; prototype; response; restraint; skills; sound; success

PROJECT SUMMARY AND ABSTRACT Hearing loss (HL) in the first two years of life can delay language development, making early diagnosis and intervention essential in the critical 3-18 mo period. Early identification of hearing loss has a significant impact on maintaining normal language development, leading to the 1-3-6 guidelines, which recommend that infants be screened by 1 mo, diagnosed by 3 mo, and receive interventions by 6 mo. However early testing is impractical using current diagnostic tests. The standard diagnostic test, the auditory brainstem response (ABR), requires that infants be still, limiting its applicability to asleep or sedated infants: the former often yields incomplete data due to waking, while sedation is used less and less due to concerns about its impact on development. Further, physiologic tests of hearing such as OAE and ABR only test for deficits in part of the auditory pathway, and miss deficits in the central auditory nervous system. Finally, the decision process using ABR is subjective, lacking a statistical basis for diagnosing HL. A survey of pediatric audiologists in Western US revealed that given the limitations of current tests, there is an urgent need for an alternative method of assessing infant hearing that is simple, quick, sedation-less, and objective. Perceptivo proposes a new hearing test based on the sound-elicited pupil dilation response (PDR). PDR is enabled by advances in software and hardware, as well as methodological innovations that enabled highly precise video tracking of pupil size in head-free infants. Infants in the relevant 3-18 mo range exhibit a strong and consistent PDR to tones at an age when speech is rapidly developing. The infant PDR assay will leverage preliminary data from 41 normal hearing infants, and the team’s considerable experience in using pupil dilation to assess sensation in non-humans and adult humans. Our data to date show that the PDR is as sensitive as traditional methods of assessing hearing using subject feedback. A provisional patent filing protects the PDR methods, and the software and hardware that comprise the PDR system. To validate PDR as a diagnostic test, it must be shown to be as sensitive, and detect the same deficits, as the ABR in a clinical setting. Therefore, software, hardware, and methods will be optimized for use at in a clinical setting. PDR-based thresholds will be measured and compared to ABR thresholds in 80 infants, 3 - 18 mo, who were referred after newborn screening, or have at-risk factors for HL. To ensure the validity of the comparison, ABR and PDR thresholds will be measured in the same infant, on the same day, using similar sounds and by the same audiologist at the Doernbecher Children’s Hospital (OHSU). Data gathered will not only validate clinical application of the PDR, but will be the first systematic assessment of sound-elicited pupil responses in infants with or without HL. This data will enable us to seek further funding for development of the PDR as a test for infant hearing, and specifically, provide the validation necessary for a Phase 2 SBIR application.

项目总结和摘要 听力损失（HL）在头两年的生活可以延迟语言的发展，使早期诊断， 在关键的3 - 18个月期间进行必要的干预。听力损失的早期识别有很大的影响 关于保持正常的语言发展，导致1 - 3 - 6指南，其中建议婴儿 1个月筛查，3个月确诊，6个月干预。然而，早期测试是不切实际的 使用当前的诊断测试。标准的诊断测试，听觉脑干反应（ABR），需要 婴儿是静止的，限制了它对睡眠或镇静婴儿的适用性：前者经常产生不完整的数据 由于清醒，而镇静剂由于担心其对发育的影响而使用得越来越少。此外，本发明还 听力的生理测试，如OAE和ABR，仅测试部分听觉通路的缺陷， 中枢听觉神经系统的缺陷。最后，使用ABR的决策过程是主观的， 诊断HL的统计学基础。一项对美国西部儿童听力学家的调查显示， 由于目前测试的局限性，迫切需要一种评估婴儿听力的替代方法， 简单、快速、无需镇静剂、客观。 Perceptivo提出了一种基于声音引起的瞳孔扩张反应（PDR）的新听力测试。人民民主共和国是 通过软件和硬件的进步，以及方法上的创新， 无头婴儿瞳孔大小的视频跟踪。在相关的3 - 18个月范围内的婴儿表现出强烈的 一致的PDR到音调的年龄时，讲话是迅速发展。婴儿PDR检测将利用 来自41名听力正常婴儿的初步数据，以及该团队在使用瞳孔扩张方面的丰富经验， 来评估非人类和成年人的感觉我们迄今为止的数据表明，PDR的敏感性与 使用受试者反馈评估听力的传统方法。临时专利申请保护PDR 方法以及构成PDR系统的软件和硬件。 为了验证PDR作为一种诊断测试，它必须被证明是敏感的，并检测到相同的缺陷，作为 临床环境中的ABR。因此，软件、硬件和方法将被优化以用于临床应用。 设置.将测量80名3 - 18个月婴儿的PDR阈值，并与ABR阈值进行比较， 在新生儿筛查后转诊，或有HL风险因素。为了确保比较的有效性， ABR和PDR阈值将在同一天，使用相似的声音，通过 Doernbecher儿童医院（OHSU）的听力学家。 收集的数据不仅将验证PDR的临床应用，而且将是第一个系统的 评估患有或不患有HL的婴儿的声音引起的瞳孔反应。这些数据将使我们能够寻求 进一步资助开发PDR作为婴儿听力测试，特别是提供验证 第二阶段SBIR应用所需的。