Adaptive olfactory threshold testing in the clinical assessment of anosmia

项目摘要 嗅觉障碍在日常生活中影响很大。煤气泄漏和变质的食物都是无法察觉的危险。 当食物变得难吃时，如果没有气味的核心作用，足够的营养就会受到影响 味觉。受影响的个人也会感到与世界和其他人脱节，从而导致 抑郁症发病率的增加。嗅觉障碍也可能是其他严重健康的早期指标 问题如鼻窦炎、颅底肿瘤、脑脊液泄漏或神经系统疾病，如 阿尔茨海默氏症、帕金森氏症或多发性硬化症。嗅觉障碍也更为常见。 比大多数人认为的要好，新冠肺炎之前的一项主要研究发现，超过12%的40岁及以上的美国人 老年人患有嗅觉减退(嗅觉能力降低)或嗅觉障碍(嗅觉障碍)。然而，尽管有大量的 尽管气味障碍的患病率和严重的健康影响仍然经常被低估，部分原因是 常规的嗅觉筛查不是初级保健的一部分。整合目标的一个主要障碍是， 常规医疗保健中经过验证的嗅觉测试表明，当前的选择过于耗时和/或昂贵。 因此，如果医疗提供者将嗅觉测试作为日常工作的一部分，则需要一个新的选择 筛查，类似于许多初级保健中使用的无处不在的斯内伦眼表和手持听力计 诊所。大约三分之一的美国成年人每年都会接受身体护理或预防护理。将嗅觉测试包括在 这样的访问将导致每年超过7500万次测试。当嗅觉障碍被诊断或怀疑时， 它通常会导致转诊到专家(例如神经学、耳鼻喉科)，并进行以下程序 手术、成像和内窥镜检查，这些都是医疗保险的账单。因此，我们预计成本低、速度快 嗅觉测试将为医疗系统提供可观的投资回报。来解决这个未得到满足的问题 需要一种强大、快速、廉价的跨文化嗅觉功能测试，可以在不同的情况下进行 设置，我们设计了自适应嗅觉阈值测量(AROMA-T)。芳香-T包括多个 一种气味的浓度分布在几个对数浓度单位上，并封装在果皮中。 和-在可折叠的卡片上拆开标签。该卡与一种通过网站实现的自适应算法配对 或APP，它引导患者通过一系列气味浓度，其中每一种都是根据 之前的回应。通过跳过非信息性浓度，这项测试可以快速确定患者的气味 检测阈值。芳香-T可以自我管理，并且规模化生产成本低廉。在这 建议，我们将追求三个具体目标，将芳香-T商业化：我们将(1) 将AROMA-T的性能与其他经过验证的气味测试进行比较；(2)开发随附的 应用于自适应算法的实时处理；以及(3)评估提供者对测试的体验 和APP在现实世界的临床环境中。总而言之，这些研究将确定技术上的优点、可行性和 香气的商业潜力-T。

Project Summary Smell disorders are highly impactful in daily life. Gas leaks and spoiled food are undetectable dangers. Adequate nutrition is compromised as food become unpalatable without the core contribution smell plays in flavor perception. Affected individuals also feel disconnected from the world and other people, contributing to an increased incidence of depression. Smell disorders may also be early indicators of other serious health problems such as rhinosinusitis, skull base tumors, cerebrospinal fluid leaks, or neurological diseases such as Alzheimer's disease, Parkinson's disease or multiple sclerosis. Smell disorders are also much more common than most people believe, with one major pre-COVID-19 study finding that over 12% Americans age 40 and older had hyposmia (a reduced ability to smell) or anosmia (an inability to smell). However, despite substantial prevalence and significant health impacts, smell disorders remain routinely underdiagnosed, in part because routine olfactory screening is not a part of primary care. A major impediment to incorporating objective, validated smell tests in routine healthcare is that the current options are too time consuming and/or expensive. Thus, a new option is needed if smell testing is to be embraced by medical providers as a part of routine screening, analogous to the ubiquitous Snellen eye chart and handheld audiometer used in many primary care clinics. Roughly a third of US adults receive an annual physical or preventive care visit. Including smell tests in such visits would result in over 75 million tests per year. When an olfactory disorder is diagnosed or suspected, it typically results in referrals to specialists (e.g., neurology, otolaryngology) and in procedures such as surgeries, imaging, and endoscopy that are billable to health insurance. Thus, we expect that a low cost, rapid smell test would provide a substantial return on investment for healthcare systems. To address this unmet need for a robust, rapid, inexpensive, cross-cultural test of olfactory function that can be administered in varied settings, we designed the Adaptive Olfactory Measure of Threshold (ArOMa-T). The ArOMa-T includes multiple concentrations of a single odorant spaced over several log units of concentration and encapsulated in peel- and-burst labels on a foldable card. The card is paired with an adaptive algorithm, implemented via a website or app, that guides the patient through a sequence of odorant concentrations where each is selected based on prior responses. By skipping non-informative concentrations, this test rapidly determines the patient's odor detection threshold. The ArOMa-T can be self-administered and produced inexpensively at scale. In this proposal, we will pursue three Specific Aims to move the ArOMa-T towards commercialization: we will (1) compare the performance of the ArOMa-T against other validated smell tests; (2) develop an accompanying application for real-time processing of the adaptive algorithm; and (3) assess provider experience with the test and app in a real world clinical setting. Together, these studies will establish the technical merit, feasibility and commercial potential of the ArOMa-T.