Wearable ultrasound systems and software for assessment of obstructive sleep apnea

用于评估阻塞性睡眠呼吸暂停的可穿戴超声系统和软件

• 批准号: 10484666
• 负责人: Stephen Restaino
• 金额: $ 29.99万
• 依托单位: SONOSA MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10484666
• 关键词: 3-Dimensional; 3D ultrasound; Address; Adenoidal structure; Adult; Affect; Air Pressure; Algorithms; Anatomy; Anesthesia procedures; Apnea; Arousal; Asphyxia; Biological Models; Breathing; Cardiovascular system; Childhood; Clinical; Clinical Trials; Comparative Study; Computer software; Continuous Positive Airway Pressure; Coupling; Data; Dental; Devices; Diagnosis; Diagnostic; Disease; Drops; Drowsiness; Effectiveness; Endoscopy; Event; Financial compensation; Future; Gel; Health; Home; Hospitals; Hour; Image; Image Analysis; Individual; Length; Life Expectancy; Location; Manuals; Maps; Maryland; Masks; Medical; Metabolic; Monitor; Nature; Nerve; Neurologic; Noise; Nose; Obesity; Obstruction; Obstructive Sleep Apnea; Operative Surgical Procedures; Oral; Oral cavity; Otolaryngologist; Outcome Study; Patient-Focused Outcomes; Patients; Periodicity; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Phenotype; Positioning Attribute; Procedures; Productivity; Pump; Relaxation; Research; Risk Factors; Scanning; Sedation procedure; Severities; Site; Sleep; Sleep Apnea Syndromes; Slice; Soft Palate; Solid; Splint Device; Stress; System; Techniques; Technology; Testing; Tissues; Titrations; Tongue; Tonsil; Ultrasonic Transducer; Ultrasonography; Universities; Validation; Vision; Visual; Wolves; Work; algorithm development; alternative treatment; automated algorithm; awake; comorbidity; design; diagnostic strategy; diagnostic technologies; diagnostic tool; early phase clinical trial; global health; image processing; imaging system; improved; indexing; innovation; meetings; neuromuscular; non-compliance; novel; novel diagnostics; pharynx muscle; prototype; psychologic; sensor; side effect; standard of care; tongue root; treatment strategy; ultrasound; uvula; wearable device

Project Summary Sonosa Medical is developing a wearable ultrasound platform to enable advanced management of Obstructive sleep apnea (OSA) at an unprecedented precision and scale. OSA is a shockingly common condition that, along with side effects and comorbidities leads to a 10-15 year drop in life expectancy. When treated adequately, OSA is a manageable condition; however, existing management strategies are not adequate to meet the current and growing problem of OSA worldwide. Diagnosis of OSA is accomplished with a polysomnogram (PSG) or home sleep apnea test (HSAT) that uses multiple sensors to indirectly count obstructions, enabling an estimate of severity score: the apnea hypopnea index (AHI, number of events per hour). Though sensitive and specific as a diagnostic, the indirect nature of PSGs both in lab and at home provide little information on the cause of a patient’s obstructions. Despite phenotypic differences in OSA caused by numerous factors, treatment decisions follow a consistent path. Treatment of OSA begins with continuous positive airway pressure (CPAP), which uses a mask over the mouth and/or nose and a pump to create a pneumatic splint that holds the entire airway open. The broad effectiveness of CPAP is often negated by the intolerable discomfort created by the air pressure, mask, and noise leading to high non-compliance rates estimated at 35-60%. Once CPAP is rejected by patients, alternative treatments include oral appliances, surgery, implantable nerve stimulators, and pharmaceuticals. Though CPAP impacts the entire airway, most alternatives target specific tissues that contribute to obstructions such as the tongue base, soft palate, uvula, tonsils and adenoids, etc. Research shows that identification of these contributing tissues, termed the level or site of obstruction (SO), can help direct treatment and improve effectiveness. Indeed, newly proposed management strategies hinge on identifying phenotypic causes of OSA. OSA presents unique diagnostic challenges that have yet to be overcome by adaptation of existing techniques. To visualize obstructions, continuous monitoring on a sleeping patient must be achieved. Further, the scale of OSA requires a technology that is physically and financially accessible outside major academic hospitals. The information gathered with existing techniques such as Drug-induced sleep endoscopy(DISE), show promise but requires invasive, expensive procedures that only mimic sleep with sedation. Sonosa Medical has developed a wearable ultrasound system that is uniquely suited to the challenges presented by OSA. As a platform, wearable airway ultrasound can provide visibility of the airway in a small, comfortable device that can be used during natural sleep. Proposed in this work are steps to collect preliminary data to inform development of algorithms for processing ultrasound data needed to simplify the diagnostic interpretation of images and determination of SO.

项目摘要 Sonosa Medical正在开发一种可穿戴超声平台，以实现对阻塞性睡眠的高级管理 以前所未有的精度和规模对阻塞性睡眠呼吸暂停（OSA）进行诊断。阻塞性睡眠呼吸暂停是一种非常常见的疾病，沿着的副作用 和合并症导致预期寿命下降10-15年。如果治疗得当，OSA是一种可管理的疾病; 然而，现有的管理策略不足以解决目前世界范围内日益严重的阻塞性睡眠呼吸暂停问题。 阻塞性睡眠呼吸暂停综合征的诊断是通过多导睡眠图（PSG）或使用多个传感器的家庭睡眠呼吸暂停测试（HSAT）完成的 间接计数阻塞，从而能够估计严重程度评分：呼吸暂停低通气指数（AHI，事件数 每小时）。尽管PSG作为诊断的敏感性和特异性，但在实验室和家庭中的间接性质几乎不能提供 关于患者阻塞原因的信息。尽管OSA的表型差异由许多因素引起， 治疗决策遵循一致的路径。OSA的治疗始于持续气道正压通气（CPAP）， 其使用覆盖在嘴和/或鼻子上的面罩和泵来产生保持整个气道的气动夹板 打开. CPAP的广泛有效性经常被空气压力、面罩、呼吸机和呼吸机所产生的无法忍受的不适所否定， 和噪音导致高不遵守率估计为35- 60%。 一旦CPAP被患者拒绝，替代治疗包括口腔矫正器、手术、植入式神经刺激器， 和药品。虽然CPAP影响整个气道，但大多数替代方案都靶向有助于呼吸的特定组织。 舌根、软腭、悬雍垂、扁桃体和腺样体等阻塞物的识别。研究表明， 这些贡献组织，称为阻塞水平或阻塞部位（SO），可以帮助指导治疗和改善 有效性事实上，新提出的管理策略取决于确定OSA的表型原因。 OSA提出了独特的诊断挑战，尚未通过适应现有技术来克服。可视化 为了避免阻塞，必须实现对睡眠患者的连续监测。此外，OSA的规模需要 在大型学术医院之外，物理和经济上都可以获得的技术。收集的信息， 现有的技术，如药物诱导睡眠内窥镜检查（DISE），显示出希望，但需要侵入性，昂贵的 只有镇静剂才能模拟睡眠 Sonosa Medical开发了一种可穿戴超声系统，该系统非常适合OSA带来的挑战。 作为一个平台，可穿戴气道超声可以在一个小而舒适的设备中提供气道的可见性， 在自然睡眠中使用。在这项工作中提出了收集初步数据的步骤，以告知算法的开发 用于处理简化图像诊断解释和SO确定所需的超声数据。