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; 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正在开发一个可穿戴的超声平台，以实现阻塞性睡眠的高级管理 呼吸暂停（OSA）以空前的精度和比例为单位。 OSA是一种令人震惊的常见条件，副作用 合并症导致预期寿命下降了10 - 15年。当适当处理时，OSA是可管理的条件； 但是，现有的管理策略不足以满足全球OSA当前和日益增长的问题。 OSA的诊断是通过使用多个传感器的多聚词（PSG）或家庭睡眠呼吸暂停测试（HSAT）完成的 间接计数对象，启用严重程度评分的估计值：呼吸暂停呼吸呼吸率（AHI，事件数量 每小时）。虽然敏感和特定为诊断，但实验室和家里的PSG的间接性质很少 有关患者目标原因的信息。尽管由许多因素引起的OSA表型差异，但 治疗决策遵循一致的道路。 OSA的处理始于连续的正气道压力（CPAP）， 它在口腔和/或鼻子和泵上使用口罩来形成气动夹板，以固定整个气道 打开。 CPAP的广泛有效性通常会因气压，掩模，面具所产生的肠胃不适而否定 噪声导致高违规率估计为35-60％。 一旦CPAP被患者拒绝，替代治疗包括口服器具，手术，可植入的神经刺激剂， 和药品。尽管CPAP会影响整个气道，但大多数替代方案都针对有助于 诸如舌底，软pa，紫罗兰，扁桃体和腺样体等障碍物。研究表明，鉴定 这些贡献的组织称为反对的水平或部位（SO），可以帮助指导治疗并改善 效力。确实，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，这些挑战尚未通过改编现有技术来克服。可视化 障碍物，必须对沉睡的患者进行连续监测。此外，OSA的规模需要一个 在大型学术医院外面在身体和财务上可以访问的技术。收集的信息 现有技术，例如药物诱导的睡眠内窥镜检查（DISE），表现出希望，但需要侵入性，昂贵 只模仿镇静的过程。 Sonosa Medical开发了一种可穿戴的超声系统，它非常适合OSA提出的挑战。 作为一个平台，可穿戴气道超声可以在一个舒适的小型设备中提供气道的可见性 自然睡眠期间使用。在这项工作中提出的是收集初步数据以告知算法开发的步骤 用于处理超声数据，以简化图像的诊断解释和确定的确定。