Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults

临床严重程度足以满足诊断标准的失眠在大约5%的老年人中存在， 仅在美国就有近130万人。如果不进行治疗，它可能会导致抑郁症的发生率增加， 认知障碍和心血管疾病。治疗依赖于药物治疗，如镇静剂、催眠药 治疗，与跌倒、事故和精神错乱的风险增加有关；认知行为 失眠疗法(CBT-I)，有效，但可能需要长达八周或更长时间，而且 受限于缺乏训练有素的提供者；以及非处方药，其中许多含有 苯海拉明，一种符合Beers标准的老年人可能不适当用药的药物 大人。显然，迫切需要开发能够治疗老年人失眠的解决方案。 宾夕法尼亚大学进行的初步研究表明，移动设备治疗 基于CBT-I和正念的核心要素(尤其是思想重定向和脱离)可以 与对照组30%的患者相比，高达55%的患者显著改善了失眠症状。 这种方法的创新方面包括使用物理任务，手指敲击计时到 呼吸周期，作为固定/重定向任务，以及实时监控患者的能力 通过无线向中央数据库传输所有攻丝的时间戳记录来遵守。这个 这种干预的直截了当的性质允许快速训练，治疗益处只有1- 2周。这种快速通道STTR的总体目标是开发和测试这种非药理学的、低风险的 治疗老年人的失眠。具体目标是：阶段I)通过以下方式细化应用程序接口 与患者和医疗保健提供者进行结构化访谈，为患者开发教育材料 在家中访问，结合加速度计数据和对20名研究参与者进行的试点临床研究；阶段 二)进一步完善教育材料，创建解释性风险分类算法，以自动 标记未坚持和无应答者进行早期干预，以及一项包含240人的大型随机对照试验 受试者确认疗效。主要假设是移动设备实现了这一点 85%的老年人可以使用带有锚定任务的监测呼吸意识疗法(MBAT)， 它将在两周内在统计和临床上显著改善失眠。 先进医疗电子拥有23年的生物医学开发经验，并拥有学术合作伙伴 (Gooneratne，Benzo)在睡眠医学、老年病学、正念疗法和临床试验方面拥有专业知识 上了年纪的人。如果成功，这个项目将为患者和医疗服务提供者提供首个低风险、低成本的服务 失眠的治疗选择，可以很容易地在老年人身上实施。它有可能会 从根本上改变治疗失眠的方式，从而降低未经治疗的失眠风险并避免 药物治疗的各种副作用，如镇静催眠药。

Insomnia of sufficient clinical severity to meet diagnostic criteria is present in approximately 5% of older adults, nearly 1.3 million individuals in the US alone. If left untreated, it can lead to increased rates of depression, cognitive impairment, and cardiovascular disease. Treatment relies on pharmacotherapy, such as sedativehypnotic therapy, which is associated with an increased risk of falls, accidents, and delirium; cognitivebehavioral therapy for insomnia (CBT-I), which is effective, but can take up to eight weeks or more and is limited by a paucity of trained providers; and over-the-counter medications, many of which contain diphenhydramine, a medication that is on the Beers Criteria for Potential Inappropriate Medications in Older Adults. There is clearly a pressing need to develop solutions that can treat insomnia in older adults. Preliminary research conducted at the University of Pennsylvania suggests that a mobile device treatment based on core elements of CBT-I and mindfulness (especially thought redirection and disengagement) can significantly improve insomnia symptoms in up to 55% of patients compared to 30% in the control arm. Innovative aspects of this approach include the use of a physical task, that of finger tapping timed to the breathing cycle, to serve as an anchoring/re-orienting task, and the ability to monitor, in real-time, patient adherence by wirelessly transmitting to a central database a time-stamped record of all taps. The straightforward nature of this intervention allows for rapid training, with treatment benefits seen in as little as 1- 2 weeks. The overall goals of this fast-track STTR are to develop and test this non-pharmacological, low-risk treatment for insomnia in older adults. Specific aims are: Phase I) Refining the application interface through structured interviews with patients and health care providers, development of educational material for patients to access at home, integration with accelerometer data and a pilot clinical study in 20 study participants; Phase II) Further refining the educational material, create interpretive risk classification algorithms to automatically flag non-adherence and non-responders for early intervention, and a large randomized controlled trial of 240 subjects to confirm efficacy. The primary hypotheses are that a mobile device implementation of this monitored breathing awareness therapy with an anchoring task (MBAT) can be used by >85% of older adults, and that it will lead to statistically and clinically significant improvements in insomnia within two weeks. Advanced Medical Electronics has 23 years of biomedical development experience, and academic partners (Gooneratne, Benzo) have expertise in sleep medicine, geriatrics, mindfulness therapy and clinical trials in older adults. If successful, this project will provide patients, and health care providers with the first low risk, lowcost treatment option for insomnia that can be readily implemented in older adults. It has the potential to fundamentally change how insomnia is treated, thereby reducing the risks of untreated insomnia and avoiding the multifarious side effects of pharmacologic treatment, such as with sedative-hypnotics.