Adaptive olfactory threshold testing in the clinical assessment of anosmia

自适应嗅觉阈值测试在嗅觉丧失临床评估中的应用

• 批准号: 10491037
• 负责人: Steven D Munger
• 金额: $ 25.21万
• 依托单位: REDOLYNT, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-10 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10491037
• 关键词: Address; Adult; Affect; Affordable Care Act; Age; Algorithms; Alzheimer' s Disease; American; Anosmia; COVID-19; COVID-19 associated anosmia; Cerebrospinal Fluid; Clinic; Clinical; Clinical assessments; Code; Collaborations; Consumption; Detection; Devices; Diagnosis; Diagnostic Reagent Kits; Discrimination; Encapsulated; Endoscopy; Europe; Eye; Feedback; Food; Functional disorder; Gases; Health; Health Insurance; Health Personnel; Healthcare; Healthcare Systems; Image; Incidence; Individual; Instruction; Insurance; Insurance Carriers; Investments; Joint Commission on Accreditation of Healthcare Organizations; Label; Language; Life; Measures; Medical; Medicare; Mental Depression; Multiple Sclerosis; National Health and Nutrition Examination Survey; Neurology; Notification; Odors; Olfaction Disorders; Operative Surgical Procedures; Otolaryngology; Output; Pamphlets; Paper; Parkinson Disease; Patient Self-Report; Patients; Pennsylvania; Perception; Performance; Persons; Phenylethyl Alcohol; Play; Prevalence; Preventive care; Primary Health Care; Procedures; Provider; Quality of life; Safety; Secure; Self Administration; Series; Skull Base Neoplasms; Smell Perception; Specialist; Tablets; Test Result; Testing; Time; Training; Universities; Visit; Visual impairment; Work; base; cognitive load; commercialization; cost; design; experience; hyposmia; memory recall; nervous system disorder; nutrition; olfactory disorder; olfactory threshold; pain scale; pandemic disease; performance tests; programs; response; rhinosinusitis; routine screening; screening; smartphone Application; smell test; web site

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.

项目摘要 气味障碍在日常生活中具有很高的影响。气体泄漏和宠坏的食物是无法检测的危险。 随着食物变得不可能，没有核心贡献的气味，足够的营养被损害 风味感知。受影响的人也感到与世界和其他人脱节，为 抑郁症发生率增加。气味障碍也可能是其他严重健康的早期指标 诸如鼻塞炎，颅底肿瘤，脑脊液泄漏或神经系统疾病等问题（例如 阿尔茨海默氏病，帕金森氏病或多发性硬化症。气味障碍也更为普遍 比大多数人认为，有一项主要的前研究前研究发现，超过12％的美国人40岁和 年龄较大的患有缺血性（闻起来降低）或厌食症（无法闻起来）。但是，尽管很大 患病率和重大健康影响，气味障碍通常诊断不足，部分原因是 常规嗅觉筛查不是初级保健的一部分。结合目标的主要障碍， 常规医疗保健中经过验证的气味测试是，当前的选择太耗时和/或昂贵。 因此，如果医疗提供者将气味测试作为例行程序的一部分，则需要一个新的选择 筛选，类似于许多初级保健中使用的无处不在的Snellen眼图和手持式听力表 诊所。我们大约有三分之一的成年人接受年度或预防性护理。包括气味测试 这样的访问每年将导致超过7500万个测试。当诊断或怀疑嗅觉障碍时 它通常导致转介给专家（例如神经病学，耳鼻喉科），以及诸如 可以根据健康保险计费的手术，成像和内窥镜检查。因此，我们期望低成本，快速 气味测试将为医疗保健系统提供可观的投资回报。解决这个尚未满足的 需要嗅觉功能的稳健，快速，廉价，跨文化测试 设置，我们设计了阈值（Aroma-T）的自适应嗅觉度量。 Aroma-T包括多个 单个气味剂的浓度在几个浓度的log单位上分布，并封装在果皮中 并在可折叠卡上标签。该卡与通过网站实现的自适应算法配对 或应用程序，可以指导患者通过一系列气味浓度，在其中选择每个浓度 先前的回答。通过跳过非信息浓度，该测试迅速确定患者的气味 检测阈值。香气-T可以自我管理和廉价地在大规模上产生。在这个 提案，我们将追求三个特定的目标，以将香气t转向商业化：我们将（1） 比较Aroma-T与其他经过验证的气味测试的性能； （2）发展随附的 实时处理自适应算法的应用； （3）评估测试的提供者经验 和应用程序在现实世界中的临床环境中。这些研究将共同​​确定技术优点，可行性和 Aroma-T的商业潜力。