PDF(Pubmed)
Abstract：
Objective The objective of this study is to evaluate the clinical performance of a novel, precision, oral appliance therapy (OAT) medical device made entirely from a US Pharmacopeia (USP) medical grade class VI qualified material for the treatment of obstructive sleep apnea (OSA). Methods This was a multi-center, single-arm, chart-based, retrospective study of 91 patients diagnosed with OSA, treated utilizing a novel, precision, OAT medical device. Performance criteria were overall efficacy (reduction of OSA events to less than 10 per hour); efficacy for patients with severe OSA (reduction of OSA events to less than 20 per hour and a 50% improvement); and compliance (the rate of continuation of treatment after at least a one-year follow-up, or, conversely, the rate of discontinuation of treatment due to material-related adverse events or side effects after one year). Results Eighty-nine percent of all subjects diagnosed with all levels of OSA severity were successfully treated to an apnea hypopnea index (\"AHI\") < 10 events per hour. Ninety-eight percent of subjects diagnosed with mild to moderate OSA were successfully treated to an AHI < 10. Eighty percent of subjects with severe OSA, without screening or excluding subjects for airway collapse profile, were successfully treated to an AHI < 20 with a 50% improvement in AHI. After a minimum one-year follow-up period, 96% of patients were confirmed to remain in active treatment. No subjects were reported to discontinue treatment due to adverse events or side effects. Conclusions This novel, precision OAT medical device made from the USP Class VI qualified material demonstrated efficacy and safety for the treatment of patients with OSA.
摘要：
目的本研究的目的是评估一种新颖的，精度,口腔矫正器治疗（OAT）医疗器械完全由美国药典（USP）医学级VI级合格材料制成，用于治疗阻塞性睡眠呼吸暂停（OSA）。方法这是一个多中心，单臂,基于图表，91例OSA患者的回顾性研究，用小说处理，精度,OAT医疗设备。表现标准是总体疗效（OSA事件减少到每小时10个以下）；重度OSA患者的疗效（OSA事件减少到每小时20个以下，改善50％）；和依从性（至少一年随访后继续治疗的比率，或者，相反,一年后因物质相关不良事件或副作用而停止治疗的比率)。结果89％被诊断为所有OSA严重程度的所有受试者均成功治疗呼吸暂停低通气指数（“AHI”）每小时<10次事件。98%的被诊断为轻度至中度OSA的受试者成功治疗AHI<10。80%的重度OSA患者,不筛查或排除受试者的气道塌陷情况，成功治疗AHI<20，AHI改善50%。经过至少一年的随访期，96％的患者被证实仍在积极治疗。没有受试者报告由于不良事件或副作用而停止治疗。结论这部小说,由USPVI类合格材料制成的精密OAT医疗器械证明了治疗OSA患者的有效性和安全性。
