SBIR Phase I: Physiological Brain Measurement for Anxiety Assessment and Trending

小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力将直接有助于加强对美国3000万至4000万患有焦虑症的成年人的护理。心理健康对社会影响广泛，全国精神疾病联盟(NAMI)报告称，美国每年有五分之一的成年人患有精神疾病。这一庞大的群体形成了一个服务严重不足的患者群体，他们才刚刚开始受到提供更有效解决方案所需的关注。此外，新冠肺炎大流行的到来只会加剧这些疾病的流行，并需要改善护理结果。大多数执业的心理健康临床医生都经历了寻求治疗焦虑、抑郁和其他障碍的患者的显著增加，这给本已不堪重负的医疗保健部门带来了负担。拟议的技术解决了对患者进行筛查和分类的更好方法的需求，提高了药物选择的精确度，并提供对健康状态的远程监测，特别是在高风险部门，以扩大患者趋势并确保有效的治疗结果。这个小企业创新研究(SBIR)第一阶段项目建立在成功的人体研究和试点工程的基础上，以进一步研发具有商业可行性的行为健康生命体征。这种生命体征测量使用可穿戴式脑电(EEG)传感器与移动设备应用程序相结合，允许基于大脑生物学对焦虑进行高精度的生理测量。第一阶段的活动重点是这一新生命体征的使能技术之一：集成到可穿戴设备中的新型脑电传感器电极，允许在任何位置和任何时间简单地进行临床级别的大脑测量。这些脑电传感器电极模拟人类皮肤的机械特性，并已通过多项研究表明，在不使用不方便和混乱的导电凝胶的情况下，可以在长时间内提供高质量的信号。第一阶段的活动将以这一平台为基础，进行一系列设计和制造实验，使这些电极可供新手用户现场更换，并将成本降低到市场上可行的程度。Pilot可穿戴设备将进行修改，以接受这些更新的电极和用户测试，以确认电气、舒适性和寿命性能。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will directly help enhance care for the 30-to-40 million adults in the U.S. that live with anxiety disorders. Mental health widely impacts society, with the National Alliance on Mental Illness (NAMI) reporting one-in-five adults in the U.S. experiencing a mental illness annually. This large group forms a vastly underserved patient population that is only beginning to receive the attention needed to provide more effective solutions. Further, the arrival of the COVID-19 pandemic has only exacerbated the prevalence of these disorders and the need for improved care outcomes. Most practicing mental health clinicians have experienced significant increases of patients seeking care for anxiety, depression, and other disorders, taxing an already overwhelmed segment of healthcare. The proposed technology addresses needs for better methods to screen and triage patients, improve precision of pharmaceutical selection, and provide remote monitoring of health states, especially in at-risk sectors, to expand patient trending and ensure effective treatment outcomes.This Small Business Innovation Research (SBIR) Phase I project builds upon successful human research studies and pilot engineering to further the R&D of a commercially viable behavioral health vital sign. This vital sign measure utilizes a wearable electroencephalogram (EEG) sensor in concert with a mobile device application that allows a high-accuracy, physiological measurement of anxiety based upon brain biology. The activities of the Phase I grant focus on one of the enabling technologies for this new vital sign: the novel EEG sensor electrodes integrated into the wearable, which allow clinical-grade brain measurements simply, in any location, and at any time. These EEG sensor electrodes mimic the mechanical properties of human skin and have been shown through several research studies to provide high-quality signals over long durations without the use of inconvenient and messy conductive gels. The Phase I activities will build upon this platform with a series of design and fabrication experiments to make these electrodes field replaceable by novice users and to reduce the cost to a point that is viable in the market. Pilot wearable devices will be modified to accept these updated electrodes and user testing conducted to confirm electrical, comfort, and longevity performance.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.