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.

项目概要 Sonosa Medical 正在开发可穿戴超声平台，以实现阻塞性睡眠的高级管理 呼吸暂停 (OSA) 的精度和规模前所未有。 OSA 是一种令人震惊的常见病症，伴随着副作用 合并症会导致预期寿命缩短 10-15 年。如果治疗得当，OSA 是可以控制的； 然而，现有的管理策略不足以解决全球范围内当前且日益严重的 OSA 问题。 OSA 的诊断是通过使用多个传感器的多导睡眠图 (PSG) 或家庭睡眠呼吸暂停测试 (HSAT) 来完成的 间接计数障碍物，从而估计严重程度评分：呼吸暂停低通气指数（AHI，事件数 每小时）。尽管作为一种诊断方法敏感且特异，但 PSG 在实验室和家庭中的间接性质几乎无法提供任何帮助。 有关患者梗阻原因的信息。尽管 OSA 的表型差异是由多种因素引起的， 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)， 它使用遮住嘴和/或鼻子的面罩和泵来创建固定整个气道的气动夹板 打开。 CPAP 的广泛有效性常常因气压、面罩、 噪音导致不合规率估计高达 35-60%。 一旦CPAP被患者拒绝，替代治疗包括口腔矫治器、手术、植入式神经刺激器、 和药品。尽管 CPAP 会影响整个气道，但大多数替代方案都针对特定组织，从而有助于 舌根、软腭、悬雍垂、扁桃体和腺样体等阻塞物。研究表明，识别 这些贡献组织，称为梗阻水平或部位 (SO)，可以帮助指导治疗并改善 效力。事实上，新提出的管理策略取决于识别 OSA 的表型原因。 OSA 提出了独特的诊断挑战，尚未通过调整现有技术来克服。可视化 障碍物，必须对熟睡的患者进行连续监测。此外，OSA 的规模需要 在主要学术医院之外在物理上和经济上都可以获得的技术。收集到的信息 现有技术，如药物诱导睡眠内窥镜检查 (DISE)，显示出前景，但需要侵入性且昂贵 仅通过镇静来模拟睡眠的程序。 Sonosa Medical 开发了一款可穿戴超声系统，该系统非常适合应对 OSA 带来的挑战。 作为一个平台，可穿戴式气道超声可以在小型、舒适的设备中提供气道的可见性，该设备可以 自然睡眠时使用。这项工作提出了收集初步数据以指导算法开发的步骤 用于处理简化图像诊断解释和 SO 测定所需的超声数据。