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: 10853721
• 负责人: LOUISE M O'BRIEN
• 金额: $ 23.03万
• 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/10853721
• 关键词: Address; Adherence; Administrative Supplement; Child; Clinical; Consultations; Data Management Resources; Device Approval; Devices; Electronics; Equity; Family; Funding; Health; High Prevalence; Institution; Medical Device; Michigan; Mission; Muscle hypotonia; Nasopharynx; Obstructive Sleep Apnea; Operative Surgical Procedures; Participant; Patients; Pharmaceutical Preparations; Procedures; Protocols documentation; Quality of life; Readiness; Recommendation; Research; Services; System; Testing; United States National Institutes of Health; airway obstruction; biomaterial compatibility; clinical translation; data exchange; data management; data sharing; equity, diversity, and inclusion; improved; meetings; multidisciplinary; positive airway pressure

Project Summary/Abstract This administrative supplement will allow implementation of data management systems to facilitate FDA 21 CFR part 11 compliant electronic systems. These systems will greatly facilitate data sharing and transfer with FDA when pursuing medical device approval. This administrative supplement additionally requests funds for regulatory support for Q submission meetings and ongoing correspondence with Federal Drug Administration. The study team is receiving partial internal support from the Michigan Institute for Clinical & Health Research, but additionally requires further expertise from third party regulatory consultation. The supplement requests additional funds for finalizing biocompatibility testing and cleaning protocols. Finally, important to the mission of equity and inclusion, there are requested funds for translational document support to facilitate Non-English speaking participants and families to participate in the study. Our institutions clinical translational services is able to help with extremely low numbers of participants, though stated could not support beyond this, recommending third party assistance. These supplemental funds are directly in accord with NIH data sharing and management initiatives. The additional funds will more effectively allow interaction and preparedness for FDA approval procedures, ultimately optimizing the value of the research to patients and families. Additionally, enhancing our ability to include as many patients from Non-English speaking backgrounds directly addresses a key INCLUDE priority for diversity, equity, and inclusion.

项目摘要/摘要 这种行政补充将允许实施数据管理系统以促进FDA 21 CFR第11部分符合电子系统。这些系统将大大促进数据共享和传输 FDA在寻求医疗设备批准时。此行政补充还要求资金 对Q提交会议和与联邦药物管理局的持续往来的监管支持。 研究团队正在获得密歇根州临床与健康研究所的部分内部支持， 但此外，需要第三方监管咨询的进一步专业知识。补充要求 用于最终确定生物相容性测试和清洁方案的其他资金。最后，对任务很重要 公平和包容性，有要求的资金用于转化文件支持，以促进非英语 演讲参与者和家庭参加研究。我们的机构临床转化服务是 能够为参与者数量极少提供帮助，尽管表示不支持此事，但 推荐第三方协助。 这些补充资金直接与NIH数据共享和管理计划一致。这 额外的资金将更有效地允许互动和准备FDA批准程序， 最终优化研究对患者和家庭的价值。此外，增强了我们的能力 包括来自非英语背景的许多患者直接解决关键包括优先级 多样性，公平和包容性。