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式超声波平台，以实现对阻塞性睡眠的高级管理 以前所未有的精确度和规模进行呼吸暂停(OSA)。阻塞性睡眠呼吸暂停是一种令人震惊的常见疾病，伴随着副作用 而合并症会导致预期寿命下降10-15年。如果治疗得当，阻塞性睡眠呼吸暂停是一种可控的情况； 然而，现有的管理战略不足以满足目前全球范围内日益严重的OSA问题。 阻塞性睡眠呼吸暂停综合征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试验(HSAT)来完成的 间接计算梗阻，从而估计严重程度分数：呼吸暂停低通气指数(AHI，事件数 每小时)。尽管作为诊断的敏感性和特异性，PSG在实验室和家庭中的间接性质提供的帮助很少 有关患者梗阻原因的信息。尽管OSA的表型差异由多种因素引起， 治疗决定遵循一条一致的道路。阻塞性睡眠呼吸暂停的治疗始于持续气道正压(CPAP)， 它使用口罩和/或鼻子和一个泵来制造一个气动夹板来支撑整个呼吸道 打开。CPAP的广泛有效性经常被空气压力、口罩、呼吸压力和呼吸压力造成的难以忍受的不适所否定， 以及导致高不合规率的噪音，估计为35%-60%。 一旦患者拒绝接受CPAP，替代治疗方法包括口腔矫治器、手术、植入式神经刺激器、 和药品。尽管CPAP影响整个呼吸道，但大多数替代方案针对的是有助于 如舌根、软腭、悬垂、扁桃体和腺样体等障碍。研究表明，识别 这些组织被称为梗阻程度或部位(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阻塞性睡眠呼吸暂停综合征的表型原因。 阻塞性睡眠呼吸暂停综合征提出了独特的诊断挑战，这些挑战尚未通过采用现有技术来克服。形象化 如有障碍物，必须实现对睡眠患者的持续监测。此外，OSA的规模需要 在主要学术医院之外，可以在身体上和经济上获得的技术。收集的信息与 现有的技术，如药物诱导的睡眠内窥镜检查(DISE)，前景看好，但需要侵入性的、昂贵的 只有在镇静状态下才能模拟睡眠的程序。 Sonosa Medical开发了一种可穿戴式超声波系统，该系统独特地适合OSA提出的挑战。 作为一个平台，可穿戴式呼吸道超声可以在一个小型、舒适的设备中提供呼吸道的可见性，该设备可以 在自然睡眠中使用。这项工作中提出了收集初步数据的步骤，以便为算法的开发提供信息 用于处理简化图像诊断解释和SO测定所需的超声数据。