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: 10518836
• 负责人: LOUISE M O'BRIEN
• 金额: $ 67.24万
• 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/10518836
• 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; 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; Sleep; Sleep Apnea Syndromes; Stents; Symptoms; Syndrome; 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; 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.

对于持续的阻塞性睡眠呼吸暂停（OSA），迫切需要安全有效的治疗选择 低渗上气道阻塞（HUAO）的患者。 HUAO包括大脑等条件 麻痹，低氧脑病，综合征异常，三体疾病或唐氏综合症和神经肌肉疾病，通常具有类似的多站点上气道塌陷的模式。 OSA的特征是在睡眠期间与相关唤醒和/或氧气疾病在睡眠期间的部分或完整的上呼吸道异常发作。与儿童之间的OSA事件相比，在1-5％之间，患有低渗条件，脑瘫和三体疾病/唐氏综合症的儿童的OSA患病率明显更高。在呼吸障碍症状的低音症患者（PSG）中，有25％的OSA中度为OSA，而56.3％的患者患有严重的OSA。那不仅患者更有可能患有OSA，而且可能会更加严重。尽管大多数患者在大多数患者中都有明显的上呼吸道崩溃，但文献中的数据很少，无论是在这些条件下的OSA的患病率和严重程度，但也涉及治疗效率 特别是关于多层次目标和以及治疗效率的持续时间。现在 可用的治疗选择，从姑息治疗到气管造口术，通常无法完全满足 这些患者。我们的多学科团队开发了一个极有效的非外科鼻咽 气道支架在低音患者中表现出良好的耐受性。 WAAO中OSA的处理提出了一个极其困难的挑战，部分原因是弥漫性多级 缺乏肌肉气道音调的阻​​塞。除了 气管切开术，可能失败。尽管手术选择（例如腺骨切除术）很常见，但大多数儿童 由于残留的解剖和身体异常，因此With Whuao在手术后具有残留的OSA。 这种经常有必要的尝试以阳性气道压力（PAP）或考虑 气管切开术。但是，在典型发展儿童中，与PAP的遵守率可能很低，甚至 在患有低渗条件的人中较低。此外，在呕吐期间无法卸下面具会构成a 窒息风险。气管切开术具有发病率和死亡率的相关风险 护理需求，家庭烧伤，护士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 - 头颈手术，睡眠医学和工程学， 已经设计，开发并成功试行了自支撑的鼻咽气道（SSNPA）设备 绕过挑战，弥漫性，多级上空气道异议。该设备已证明了初始 一组患者的安全性和初步效率，严重的OSA。赠款的启动阶段（R61） 将测试设备的增强版本，以实现可接受性和耐受性。批判性，插入，依从性和 合规协议将被优化以制备R33阶段。 R33阶段将评估有能力的 研究PSG和生活质量成果。