Auto-Titrating Oral Appliance for Sleep Disordered Breathing

用于睡眠呼吸障碍的自动滴定口腔矫治器

• 批准号: 10697976
• 负责人: Julie Lundstrom
• 金额: $ 29.93万
• 依托单位: RUSH RIVER RESEARCH CORPORATION
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10697976
• 关键词: Achievement; Air; Alternative Therapies; Appointment; Automation; Beds; Biomechanics; Blood Pressure; Cessation of life; Clinical Trials; Collaborations; Computer software; Congestive Heart Failure; Consumption; Continuous Positive Airway Pressure; Coronary Arteriosclerosis; Cost of Illness; Custom; Dental; Dentists; Development; Devices; Diabetes Mellitus; Dose; Drug resistance; Electrical Engineering; Electronics; Engineering; Evaluation; Evolution; Feedback; Financial Hardship; Goals; Heart Diseases; Heart Rate; Heart failure; Home; Human; Inflammation; Intelligence; Jaw; Link; Malignant Neoplasms; Mandible; Mandibular Advancement; Manuals; Marketing; Masks; Mechanics; Medical; Medical Device; Medicine; Methods; Micromanipulation; Monitor; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Operative Surgical Procedures; Oral; Oral Medicine; Oral cavity; Otolaryngology; Patients; Pennsylvania; Persons; Pharyngeal structure; Phase; Pilot Projects; Population; Positioning Attribute; Process; Qualifying; Quality of life; Research; Resistant Hypertension; Resources; Respiratory Sounds; Risk; Safety; Screening procedure; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Specialist; Stroke; Surgeon; System; Technology; Temporomandibular Joint; Testing; Therapeutic; Time; Titrations; United States; Universities; Visit; Wireless Charging; adherence rate; airway obstruction; commercialization; design; efficacy evaluation; experience; flexible electronics; human study; impression; improved; innovation; mid-career faculty; novel; pilot trial; premature; prototype; research and development; smartphone application; success; wireless

Project Summary/Abstract Rush River Research Corp. (RRR) proposes to develop an auto-titrating oral appliance that fits fully-in-the-mouth for Sleep Disordered Breathing (SDB) therapy. SDB, resulting from airway obstruction, is directly linked to the four most costly diseases in the United States: heart disease, diabetes, obesity, and cancer. Research has shown that SBD sufferers are three times more likely to die prematurely. Current therapeutic devices, such as CPAP, surgery, and traditional non-auto-titrating oral appliances are the most common therapy approaches to SBD, with CPAP being considered the gold standard. Despite 30 years of CPAP commercialization, 90% of the potential U.S. and worldwide markets for SDB therapy remain untreated. Lack of toleration of CPAP leads to poor compliance among users. Oral mandibular advancement appliances typically provided, fit, and titrated by dentists are often an alternative for patients with unsuccessful experiences with CPAP or with mild SDB. However, the titration process can require multiple visits to the dentist over several months and the dentists lack feedback on compliance and efficacy during and after titration. Inflammation of the temporomandibular joint (TMJ) resulting from the fixed and continuous artificial advancement of the mandible can also occur. The proposed connected auto-titrating, SDB sensing, oral appliance can mitigate issues with the titration process and be optimized to provide minimum therapy necessary to improve user safety and comfort. RRR and collaborators propose to show feasibility of a fully-in-the-mouth micro manipulating oral appliance by developing a prototype appliance and demonstrating functionality in an overnight human study of people suffering from SDB. RRR has assembled a highly qualified team of Sleep and Oral Medicine experts and experienced medical device designers to achieve these goals.

项目摘要/摘要 Rush River Research Corp.（RRR）建议开发适合的自动互动口服器具 睡眠不足呼吸（SDB）疗法的口中。气道阻塞导致的SDB是 与美国的四种最昂贵的疾病直接相关：心脏病，糖尿病，肥胖和 癌症。研究表明，SBD患者过早死亡的可能性是三倍。当前的 CPAP，手术和传统的非自动trating术的治疗设备最多是最多的 SBD的常见治疗方法，CPAP被认为是黄金标准。尽管有30年 CPAP商业化，90％的美国和全球SDB治疗市场仍未治疗。 CPAP缺乏耐受性会导致用户之间的依从性不佳。口服下颌促进设备 通常提供，适合和滴定牙医通常是失败的患者的替代品 CPAP或轻度SDB的经验。但是，滴定过程可能需要多次访问 牙医在几个月内，牙医缺乏有关在和之后的合规性和功效的反馈 滴定。固定且连续的人造引起的颞下颌关节（TMJ）的炎症 下颌骨的进步也可能发生。提议的连接自动互动，SDB感应，口服 设备可以减轻滴定过程的问题，并得到优化以提供最低限度的治疗 提高用户安全和舒适性所需的必要条件。 RRR和合作者建议展示 通过开发原型设备并证明，完全在口中的微型操纵口服设备 一夜人类研究患有SDB的人的功能。 RRR组装了高度合格 睡眠和口腔医学专家团队以及经验丰富的医疗设备设计师，以实现这些目标。