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

用于治疗阻塞性睡眠呼吸暂停的 SleepFlexTM 头颈锻炼计划

• 批准号: 10080880
• 负责人: ERIC JAMES KEZIRIAN
• 金额: $ 25.21万
• 依托单位: BERENDO SCIENTIFIC, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-21 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10080880
• 关键词: Adherence; Adoption; Adverse event; Air Movements; Anatomy; Android; Anterior; Apnea; Arousal; Attention; Cardiovascular system; Cervical; Complex; Deglutition Disorders; Device Designs; Devices; Diagnosis; Dilator; Disease; Drowsiness; Endocrine; Enrollment; Ensure; Excessive Daytime Sleepiness; Exercise; Exhalation; Feasibility Studies; Feedback; Functional disorder; Generations; Head and neck structure; Hypoglossal nerve structure; Inhalation; Instruction; Language; Lateral; Maintenance; Measures; Membrane; Morbidity - disease rate; Muscle; Neck; Obstructive Sleep Apnea; Operative Surgical Procedures; Oral; Oropharyngeal; Pain; Participant; Pathogenesis; Pathologist; Patients; Performance; Persons; Phase; Physiological; Placebos; Program Development; Protocols documentation; Public Health; Quality of life; Randomized; Research; Resistance; Resolution; Risk; Role; Severities; Silicones; Sleep; Small Business Innovation Research Grant; Snoring; Soft Palate; Speech; Tongue; Tooth structure; Vehicle crash; Visit; Visual; Wakefulness; airway obstruction; base; design; exercise program; improved; indexing; meetings; mortality; muscle strength; pressure; programs; randomized placebo controlled trial; relating to nervous system; respiratory; safety study; sleep quality; smartphone Application; treatment program; usability

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.

我们建议开发一种简单、非侵入性的阻塞性睡眠呼吸暂停 (OSA) 治疗方法 通过头部和颈部锻炼来增强口腔、咽部和颈部肌肉的力量。 OSA 是一种睡眠期间反复上呼吸道阻塞的疾病，与 大量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事故。由于目前的疗法已 存在巨大的局限性，许多患者无法接受，还有巨大的未得到满足 需要有效、耐受性良好、安全和非侵入性的 OSA 治疗。口腔、咽部和 颈部肌肉扩张上呼吸道并在清醒时保持呼吸道通畅；睡觉 与肌肉神经输入减少有关，导致肌肉力量减少 opening the airway.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。用于 OSA 治疗的头颈锻炼有 在过去十年中受到关注，多项安慰剂对照随机研究 OSA 有所改善但未完全解决。以前的方法有重要意义 限制。我们的策略是简化、有效、安全、无创的头颈锻炼 借助智能手机应用程序用户界面提供的程序，以提供指导和 借助简单的设备反馈适当的锻炼表现。 SleepFlex™ 将 增加关键肌肉的力量，以增加睡眠期间的扩张肌力量。我们的计划 包括旨在增强舌头肌肉力量的头部和颈部练习， 软腭、咽侧壁和颈部。第一阶段 SBIR 提案包括计划 开发并进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。用户界面将是一个智能手机应用程序（iOS 和 Android） 包含教学视频以及其他有关正确的视觉和书面信息 练习的表现。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：完成设计和制造工作 设备。每个练习都需要一个能够实现适当性能的设备 适当的阻力水平。目标 3：进行飞行员安全和可行性研究。我们将 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 无法耐受气道正压治疗的人。所有研究参与者将 接受为期 8 周的 SleepFlex™ 计划治疗。不良事件（疼痛、 将测量吞咽困难）、可用性以及计划接受度和依从性。