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

基本信息

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
项目类别：
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&apos 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

项目摘要

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.

项目概要嗅觉障碍对日常生活影响很大。煤气泄漏和变质的食物是无法察觉的危险。如果没有气味发挥核心作用，食物就会变得难吃，因此充足的营养就会受到影响风味感知。受影响的人还感到与世界和其他人脱节，从而导致抑郁症的发病率增加。嗅觉障碍也可能是其他严重健康问题的早期指标鼻窦炎、颅底肿瘤、脑脊液漏等问题，或神经系统疾病，例如阿尔茨海默病、帕金森病或多发性硬化症。嗅觉障碍也更常见超出大多数人的想象，一项关于新冠肺炎 (COVID-19) 疫情之前的重大研究发现，超过 12% 的美国人年龄在 40 岁以下老年人有嗅觉减退（嗅觉能力下降）或嗅觉丧失（无法嗅觉）。然而，尽管实质性尽管嗅觉障碍的流行率和对健康的重大影响，但嗅觉障碍仍然经常被诊断不足，部分原因是常规嗅觉筛查不是初级保健的一部分。纳入目标的主要障碍，在常规医疗保健中经过验证的气味测试的缺点是，当前的选择过于耗时和/或昂贵。因此，如果医疗服务提供者要将气味测试作为常规的一部分，就需要一种新的选择筛查，类似于许多初级保健中使用的无处不在的斯内伦视力表和手持式听力计诊所。大约三分之一的美国成年人每年接受一次身体或预防性护理就诊。包括气味测试此类访问每年将带来超过 7,500 万次检测。当诊断或怀疑嗅觉障碍时，它通常会导致转诊给专家（例如神经科、耳鼻喉科）并进行以下程序：由健康保险计费的手术、成像和内窥镜检查。因此，我们希望能够以低成本、快速的方式气味测试将为医疗保健系统带来可观的投资回报。为了解决这个未满足的问题需要一种稳健、快速、廉价、跨文化的嗅觉功能测试，可以在不同的环境中进行设置，我们设计了自适应嗅觉阈值测量（ArOMa-T）。 ArOMa-T 包括多个单一气味剂的浓度分布在几个浓度对数单位上，并封装在果皮中并爆裂可折叠卡片上的标签。该卡与自适应算法配对，通过网站实现或应用程序，引导患者通过一系列气味剂浓度，其中每个浓度都是根据之前的回应。通过跳过无信息的浓度，该测试可以快速确定患者的气味检测阈值。 ArOMa-T 可以自我管理，并且可以廉价地大规模生产。在这个提案中，我们将追求三个具体目标，以推动 ArOMa-T 走向商业化：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) 制定配套的自适应算法实时处理的应用； (3) 评估提供者的测试经验和应用程序在现实世界的临床环境中。这些研究将共同确定技术优点、可行性和 ArOMa-T 的商业潜力。