A Therapeutic Wearable Sensor for Dysphagia

1项目摘要：在全球4200万阿尔茨海默病及相关痴呆症患者中，13%至57%(550万至2400万人)出现吞咽困难或吞咽问题。在这一脆弱人群中，吞咽困难的后遗症包括营养不良、脱水和吸入性肺炎。由于吞咽和呼吸共享一个共同的解剖路径，精确的协调至关重要。在正常人中，吞咽发生在中晚期呼吸衰竭之间的一个很好的调节时期，这对呼吸道保护有好处。在吞咽困难时，这种呼吸吞咽的协调性就会丧失。尽管痴呆症患者吞咽困难的发生率很高，其后果也很严重，但可用的诊断和治疗方式有限。目前对ADRD患者吞咽困难的治疗标准是行为吞咽疗法，由受过专门训练的语言病理学家进行。具体地说，我们的研究团队最近开创了一种新的跨系统训练方法，通过4-8次临床会议，通过视觉生物反馈直接优化呼吸-吞咽时间(RST)。然而，这种培训必须在诊所进行，并且需要大型、昂贵、笨重和多线的系统。由于缺乏家庭训练，功能改进的延续受到阻碍。解决吞咽困难的新技术，特别是ADRD，需要显著的以用户为中心的设计、可在家中部署的简单操作，以及最小的看护负担和健壮性。我们之前开发了一种柔软、灵活、完全无线的喉部部署可穿戴传感器，能够持续跟踪呼吸和吞咽。我们建议增加一个振动触觉马达，以实现基于家庭的治疗，在治疗师培训后总结RST治疗。这款新的治疗性可穿戴设备将在未达到吞咽的最低阈值时，在家中轻轻振动以刺激吞咽，作为一种强化运动。此外，该设备还提供额外的反馈，以加强根据佩戴者独特的呼气节奏个性化的安全燕子。首先，我们将进行焦点小组，以实现以用户为中心的设计。然后，我们建议在一小部分轻度AD患者(临床医生痴呆率≤1)中验证该传感器。最后，我们将在一个简短的家庭试验中评估传感器的接受度。这项提议与NIA的RFA优先事项一致，旨在开发创新、高效、可扩展和低成本的辅助技术

1 PROJECT SUMMARY: Of the 42 million individuals worldwide with Alzheimer’s disease and related dementias (ADRD), 13% to 57% (5.5 to 24 million individuals) suffer dysphagia or swallowing problems. The sequelae of dysphagia in this vulnerable population include malnutrition, dehydration, and aspiration pneumonia. Since swallowing and breathing share a common anatomical pathway, precise coordination is critical. In normal individuals, swallowing occurs in a well-regulated period between mid-to-late respiratory expiration, which imparts airway protective benefits. In dysphagia, this respiratory-swallowing coordination is lost. Despite the high prevalence of dysphagia in individuals with dementia and the seriousness of the consequences, there are limited diagnostic and therapeutic modalities available. The current standard of care for dysphagia in ADRD is behavioral swallowing therapy with specially-trained speech-language pathologists. Specifically, our research team has recently pioneered a novel cross-system training approach with 4-8 in-clinic sessions that directly optimizes respiratory-swallow timing (RST) through visual biofeedback. However, this training must be done in-clinic and requires large, expensive, bulky, and multi-wired systems. Carry over of functional improvements is impeded by the absence in-home training. New technologies addressing dysphagia specifically ADRD requires significant user-centric design, straightforward operation that is deployable at home with minimal caretaker burden, and robustness. We have previously developed a soft, flexible, and fully wireless throat-deployed wearable sensor capable of continuously tracking respiration and swallowing. We propose adding a vibratory haptic motor to enable a home-based therapy that recapitulates RST therapy after therapist training. This new therapeutic wearable would vibrate gently to stimulate swallowing at home as a strengthening exercise whenever a minimum threshold of swallowing is not met. In addition, the device provides additional feedback that reinforces safe swallows personalized to the wearer’s unique expiratory cadence. First, we will conduct focus groups to enable user-centric design. Then, we propose to validate this sensor in a small cohort of persons with mild AD (Clinician Dementia RatingTM≤1). Finally, we will evaluate acceptance of the sensor in a short home trial. This proposal aligns with NIA priorities for this RFA, which aims to develop assistive technologies that are innovative, efficacious, scalable, and low-cost