PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Gra

PHS 2018-02 NIH、CDC 和 FDA 小型企业创新研究综合征集

• 批准号: 9907955
• 负责人: Suneel Ismail Sheikh
• 金额: $ 65.86万
• 依托单位: ASTER LABS, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2020-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9907955
• 关键词: PHS; 2018; 02; Omnibus; Solicitation

Abstract In this Phase II SBIR project, ASTER Labs will enhance a hands-free automatic oral hygiene device in the form of a comfortable mouthpiece that was designed and successfully tested and evaluated during a Phase I study for persons with oral hygiene disabilities and their caregivers, and then investigate the device’s efficacy in reducing dental plaque and reducing burden, thereby improving quality of life. Many people with neurological, neuromuscular, and developmental disorders, including those suffering physical injury or tremors, are at a higher risk of poor oral health, dental caries, periodontal disease, and soft tissue pathology compared to those without disability. This population of roughly 32 million disabled Americans encounters barriers to routine, comfortable, and effective oral hygiene care, due to problems with grasp, muscle control, range of motion, and reduced dexterity. Many face reduced independence, requiring caregiver assistance to perform daily dental care. These caregivers report great difficulty effectively performing these services due to lack of training, time, or confidence in managing complexities of oral hygiene care. Surveys of current devices to aid these tasks for disabled persons show only limited manual solutions, including props to keep the mouth open and modified toothbrush grips. Current electric toothbrushes require manual control. Inadequate daily hygiene promotes oral disease in the disabled, who are then subject to dental care access barriers due to limited finances, inadequate Medicaid coverage, and a limited pool of professionals trained in disability care. A significant unmet need exists to support better oral hygiene for the disabled and their caregivers with a safe, automatic, affordable, practical solution to promote daily dental care and reduce burden. To address this problem, ASTER Labs, Inc. has developed an effective and novel prototype hands-free automatic system to simplify routine oral hygiene care. The device uses powered moving bristles in a flexible mouthpiece, simply inserted into the mouth to gently remove plaque and debris from teeth and gums. The design includes multiple features to ensure comfort and safety during daily care, including embedded sensors to adjust intensity and speed of the bristle motion. Usage information is wirelessly transmitted to caregivers monitoring care status via an LCD display on a recharging and cleaning base station. These regular reports will promote adherence by preventing disruption in daily hygiene. By providing a technically advanced but practical dental care system for this vulnerable population to use in their homes or care facilities, regular, effective oral hygiene can be improved, reducing risk of preventable oral disease and need for treatment. This Phase II SBIR will evaluate efficacy of this system to provide patients and caregivers with an effective, hands-free method for routine oral hygiene care to improve quality of life, reduce effort and difficulty, and maintain adherence to recommended care. Randomized controlled evaluations will be completed using semi-structured interviews and observation data collected on 110 persons with moderate oral hygiene disabilities, family caregivers, and/or professional care providers.

抽象的 在此II阶段SBIR项目中，Aster Labs将以形式增强免提自动口服卫生装置 在I阶段研究中设计和成功测试和评估的舒适烟嘴 对于口腔卫生疾病及其护理人员的人，然后研究设备的效率 减少牙菌斑并减少伯恩（Burnen），从而改善生活质量。许多患有神经系统的人 神经肌肉和发展的疾病，包括遭受身体伤害或震颤的疾病，处于 与之相比 没有残疾。大约3200万残疾人的人口遇到了常规的障碍， 由于掌握，肌肉控制，运动范围和 敏捷降低。许多人面临降低的独立性，需要护理人员帮助执行每日牙齿 关心。这些护理人员报告说，由于缺乏培训，时间， 或对管理口腔卫生护理复杂性的信心。对当前设备的调查，以帮助这些任务 残疾人仅显示有限的手动解决方案，包括保持嘴巴张开和修改的道具 牙刷握住。当前的电动牙刷需要手动控制。每日卫生不足促进口服 残疾人的疾病，他们因财务有限而受到牙科护理障碍的影响 医疗补助的覆盖范围以及受过残疾护理培训的专业人士库有限。一个很大的未满足需求 存在以支持安全，自动，负担得起的残疾人及其护理人员的更好的口腔卫生 实用的解决方案，以促进日常牙科护理并减少伯恩。为了解决这个问题，Aster Labs，Inc。 已经开发了一种有效且新型的无提自动系统，以简化常规口腔卫生 关心。该设备在灵活的喉舌中使用动力移动的刷毛，只需插入口中 轻轻从牙齿和牙龈上清除牙菌斑和碎屑。该设计包括多个功能以确保舒适 以及日常护理期间的安全性，包括嵌入式传感器以调节刷毛运动的强度和速度。 使用信息通过在 充电和清洁基站。这些常规报告将通过防止中断来促进依从性 每日卫生。通过为这种脆弱的技术提供技术先进但实用的牙科护理系统 可以在其家中或护理设施中使用的人口，可以改善常规，有效的口腔卫生，从而降低风险 可预防的口腔疾病和需要治疗。此II阶段SBIR将评估该系统的效率 为患者和看护人提供一种有效的，免提的方法，以进行常规口腔卫生护理以改善 生活质量，减少努力和难度，并保持对建议护理的依从性。随机 对照评估将使用半结构化访谈和收集的观察数据完成 110人患有中度口腔卫生疾病，家庭护理人员和/或专业护理提供者。