SleepFlexTM head and neck exercise program for the treatment of obstructive sleep apnea

我们建议开发一种简单、非侵入性的治疗阻塞性睡眠呼吸暂停(OSA)的方法 使用头部和颈部练习来增加口腔、咽部和颈部的肌肉力量。OSA 是一种睡眠期间反复上呼吸道阻塞的障碍，与 严重的心血管疾病发病率和死亡率、内分泌紊乱、白天 嗜睡、生活质量下降和机动车撞车。就像目前的治疗方法一样 有很大的局限性，是许多患者不能接受的，有巨大的未满足 需要有效、耐受性好、安全和非侵入性的阻塞性睡眠呼吸暂停治疗。口腔、咽部和 清醒时颈部肌肉扩张上呼吸道并保持呼吸道通畅；睡眠 与肌肉神经输入的减少有关，从而导致肌肉力量的减少 打开呼吸道。增加这些肌肉的力量可以增加上呼吸道扩张器 来自相同神经输入的肌肉力量。治疗阻塞性睡眠呼吸暂停综合征的头部和颈部锻炼有 在过去的十年中，通过多项安慰剂对照的随机研究获得了关注 OSA有改善，但未完全解决。以前的方法具有重要的 限制。我们的策略是一种简单、有效、安全和非侵入性的头颈锻炼。 在智能手机应用程序用户界面的帮助下提供指令和 借助简单的设备反馈正确的运动表现。SleepFlex™将 增加关键肌肉的力量，在睡眠中增加扩张肌的力量。我们的节目 包括头部和颈部练习，以增加舌肌的力量， 软腭部、咽侧壁和颈部。此第一阶段SBIR建议书包括计划 开发并执行试点安全和可行性研究。目标1：开发智能手机 应用程序用户界面。用户界面将是智能手机应用程序(iOS和Android)， 包含教学视频以及其他适当的可视和书面信息 演练的表现。用户界面还将包括会话提醒和 跟踪遵守情况和用户反馈。目标2：完成设计和制造练习 设备。每个练习都需要一个设备，使其能够在 适当水平的抵抗力。目标3：进行飞行员安全和可行性研究。我们会 招募10名先前诊断为轻度至中度阻塞性睡眠呼吸暂停的研究参与者 他们已经不能耐受气道正压治疗。所有研究参与者将 使用SleepFlex™计划进行为期8周的治疗。不良事件(疼痛、 吞咽困难)、可用性以及程序的接受度和依从性将被测量。

We propose to develop a simple, non-invasive treatment for obstructive sleep apnea (OSA) that uses head and neck exercises to increase oral, pharyngeal, and cervical muscle strength. OSA is a disorder of repeated upper airway obstruction during sleep that is associated with substantial cardiovascular morbidity and mortality, endocrine disturbances, daytime somnolence, decreased quality of life, and motor vehicle crashes. As current therapies have substantial limitations and are not acceptable to many patients, there is an enormous unmet need for effective, well-tolerated, safe, and non-invasive OSA treatments. Oral, pharyngeal, and cervical muscles dilate the upper airway and maintain airway patency during wakefulness; sleep is associated with a decrease in neural input to muscles, leading to a decrease in muscle forces opening the airway. Increasing the strength of these muscles can increase upper airway dilator muscle force from the same neural input. Head and neck exercises for OSA treatment have received attention over the past decade, with multiple placebo-controlled, randomized studies showing improvement but incomplete resolution of OSA. Previous approaches have important limitations. Our strategy is a simplified, effective, safe, and non-invasive head and neck exercise program delivered with the aid of a smartphone app user interface to provide instruction and feedback for proper exercise performance with the aid of simple devices. SleepFlex™ will increase strength of key muscles to increase dilator muscle force during sleep. Our program includes head and neck exercises selected to increase strength of the muscles of the tongue, soft palate, lateral pharyngeal walls, and neck. This Phase I SBIR proposal includes program development and performing a pilot safety and feasibility study. Aim 1: Develop smartphone app user interface. The user interface will be a smartphone app (iOS and Android) that incorporates instructional videos as well as other visual and written information on proper performance of the exercises. The user interface will also include session reminders and tracking of adherence and user feedback. Aim 2: Finalize design and manufacture exercise devices. The exercises will each require a device that enables proper performance with appropriate levels of resistance. Aim 3: Perform pilot safety and feasibility study. We will enroll 10 study participants with previously-diagnosed mild to moderate obstructive sleep apnea who have been unable to tolerate positive airway pressure therapy. All study participants will undergo treatment for 8 weeks with the SleepFlex™ program. Adverse events (pain, dysphagia), usability, and program acceptance and adherence will be measured.