Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia

自支撑鼻咽气道 (ssNPA) 治疗肌张力低下的上气道阻塞

• 批准号: 10707489
• 负责人: LOUISE M O'BRIEN
• 金额: $ 63.99万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10707489
• 关键词: Address; Adherence; Anatomy; Anoxic Encephalopathy; Apnea; Arousal; Asphyxia; Bypass; Caregivers; Caring; Cerebral Palsy; Child; Childhood; Clinical; Clinical Trials; Clinical assessments; Controlled Clinical Trials; Data; Device Approval; Devices; Diffuse; Discipline of Nursing; Down Syndrome; Effectiveness; Engineering; Evaluation; Failure; Family; Goals; Grant; Head and Neck Surgery; Healthcare; High Prevalence; Home; Incidence; Intervention; Literature; Maintenance; Masks; Medical Care Costs; Medicine; Molecular Abnormality; Morbidity - disease rate; Muscle; Muscle hypotonia; Nasopharynx; Neuromuscular Diseases; Obstruction; Obstructive Sleep Apnea; Operative Surgical Procedures; Otolaryngology; Outcome; Oxygen; Palliative Care; Patients; Pattern; Phase; Physiological; Polysomnography; Population; Preparation; Prevalence; Procedures; Protocol Compliance; Protocols documentation; Quality of life; Questionnaires; Randomized; Recurrence; Residual state; Resources; Risk; Safety; Severities; Site; Sleep; Sleep Apnea Syndromes; Stents; Symptoms; Testing; Tracheostomy procedure; Translations; Treatment Efficacy; Vomiting; Waiting Lists; adherence rate; aged; airway obstruction; arm; cohort; desensitization; design; effective therapy; family burden; improved; inclusion criteria; indexing; meetings; mortality; multidisciplinary; novel; pediatric patients; positive airway pressure; safety assessment; sleep quality; standard of care; treatment duration

There is a critical need for safe and effective treatment options for persistent obstructive sleep apnea (OSA) in patients with Hypotonic Upper Airway Obstruction (HUAO). HUAO encompass conditions such as cerebral palsy, hypoxic encephalopathy, syndromic tone anomalies, Trisomy 21 or Down Syndrome, and neuromuscular disorders, and typically share a similar pattern of multisite upper airway collapse. OSA is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep with associated arousals and/ or oxygen desaturations. In contrast to the incidence of OSA among children which is between 1-5%, there is a significantly higher prevalence of OSA among children with hypotonic conditions, cerebral palsy, and Trisomy 21/Down Syndrome. Of hypotonic patients undergoing polysomnography (PSG) for symptoms of sleep disordered breathing, 25% had moderate OSA, and 56.3% had severe OSA. Thus, not only are patients more likely to have OSA, but it is likely to be much more severe. Despite the obvious upper airway collapse seen in most of these patients, there is a paucity of data in literature, both on prevalence and severity of OSA in these conditions, but also on treatment efficacy particularly with regards to multi-level obstruction and moreover, with duration of treatment efficacy. Currently available treatment options, ranging from palliative care to tracheostomy, often fail to fully meet the needs of these patients. Our multidisciplinary team has developed a dramatically effective non-surgical nasopharyngeal airway stent that has demonstrated good tolerability in hypotonic patients. Treatment of OSA in HUAO presents an extremely difficult challenge, in part due to diffuse multilevel obstruction with lack of muscular airway tone. This renders many surgical approaches, other than tracheostomy, likely to fail. Although surgical options such as adenotonsillectomy are common, most children with HUAO have residual OSA after the procedure, due to residual anatomic and physiological abnormalities. This often necessitates attempted treatment with Positive Airway Pressure (PAP) or consideration for tracheostomy. However, the rate of adherence with PAP in typically developing children can be low, and even lower in those with hypotonic conditions. Moreover, inability to remove a mask during an emesis can pose a suffocation risk. Tracheostomy carries associated risks for morbidity and mortality, a substantial addition of care needs, family burden, nursing demands, and hundreds of thousands of dollars of medical costs. Our multidisciplinary team, led by Otolaryngology – Head and Neck Surgery, Sleep Medicine, and Engineering, has designed, developed, and successfully piloted a self-supported nasopharyngeal airway (ssNPA) device that bypasses challenging, diffuse, multilevel upper airway obstruction. The device has demonstrated initial safety and preliminary efficacy in a pilot group of patients, severe OSA. The Start-up phase (R61) of the grant will test an enhanced version of the device for acceptability and tolerability. Critically, insertion, adherence, and compliance protocols will be optimized for preparation of the R33 phase. The R33 phase will assess a powered cohort looking at PSG and quality of life outcomes.

持续性阻塞性睡眠呼吸暂停 (OSA) 迫切需要安全有效的治疗方案 低张力上呼吸道阻塞 (HUAO) 患者包括脑等疾病。 麻痹、缺氧性脑病、音调异常、21 三体症或唐氏综合症以及神经肌肉疾病，并且通常具有相似的多部位上气道塌陷模式，其特征是睡眠期间反复发作部分或完全上气道阻塞，并伴有相关的唤醒和睡眠。与儿童中 1-5% 的 OSA 发生率相比，低渗儿童中 OSA 的患病率明显更高。在因睡眠呼吸障碍症状而接受多导睡眠监测 (PSG) 的低渗患者中，25% 患有中度 OSA，56.3% 患有重度 OSA。 OSA，但其情况可能要严重得多，尽管大多数患者都出现明显的上呼吸道塌陷，但文献中关于 OSA 患病率和严重程度的数据却很少。在这些情况下，还取决于治疗效果 特别是对于多级阻塞以及目前的治疗效果持续时间。 现有的治疗方案，从姑息治疗到气管切开术，往往无法完全满足患者的需求 我们的多学科团队开发出了一种非常有效的非手术鼻咽治疗方法。 气道支架已在低渗患者中表现出良好的耐受性。 华奥的 OSA 治疗提出了极其困难的挑战，部分原因是由于弥漫性多层次的 由于缺乏肌肉气道张力而导致阻塞，这使得除此之外还有许多手术方法。 气管切开术，可能会失败尽管腺样体扁桃体切除术等手术选择很常见，但大多数儿童。 由于残留的解剖和生理异常，HUAO 患者在手术后有残留的 OSA。 这通常需要尝试气道正压通气 (PAP) 治疗或考虑 然而，正常发育儿童的气管切开术依从率可能较低，甚至可能较低。 此外，在呕吐期间无法摘下面罩可能会导致低渗症状。 气管切开术具有相关的发病率和死亡率风险，大大增加了窒息风险。 护理需求、家庭负担、护理需求以及数十万美元的医疗费用。 我们的多学科团队由耳鼻喉科、头颈外科、睡眠医学和工程学领导， 设计、开发并成功试用了自立式鼻咽通气道 (ssNPA) 装置 该装置已被证明可以绕过具有挑战性的、弥漫性的、多层次的上呼吸道阻塞。 资助的启动阶段 (R61) 试验患者组的安全性和初步疗效。 将测试该设备的增强版本的可接受性和耐受性，关键是插入、依从性和耐受性。 合规协议将针对 R33 阶段的准备进行优化 R33 阶段将评估动力。 研究 PSG 和生活质量结果的队列。