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.

摘要 在这个第二阶段的SBIR项目中，ASTER实验室将以以下形式增强一种免提自动口腔卫生设备 在第一阶段研究期间设计并成功测试和评估的舒适牙套 口腔卫生残障人士及其照顾者，然后调查该设备在 减少牙菌斑，减轻负担，从而提高生活质量。许多人患有神经性疾病， 神经肌肉和发育障碍，包括那些遭受身体损伤或震颤的人，处于 口腔健康不良、龋齿、牙周病和软组织病理的风险比 没有残疾。大约有3200万美国残疾人在日常生活中遇到了障碍， 舒适和有效的口腔卫生护理，由于抓握、肌肉控制、活动范围和 灵活度降低。许多人的独立性降低，需要护理员帮助他们进行日常牙科治疗 关心。这些照顾者报告说，由于缺乏培训、时间、 或对管理口腔卫生护理的复杂性的信心。对当前设备进行调查，以帮助完成这些任务 残疾人只能展示有限的手动解决方案，包括保持嘴巴张开和修改的道具 牙刷把。目前的电动牙刷需要手动控制。日常卫生不足促进口腔健康 残疾人中的疾病，由于资金有限，他们随后受到牙科护理的障碍，不足 医疗补助覆盖范围，以及有限的受过残疾护理培训的专业人员。未得到满足的重大需求 旨在为残疾人及其照顾者提供安全、自动、负担得起的 实用的解决方案，促进日常牙科护理，减轻负担。为了解决这个问题，ASTER Labs，Inc. 开发了一种有效和新颖的免提自动系统原型，以简化日常口腔卫生 关心。该装置在灵活的牙套中使用电动移动刷毛，只需将其插入口腔即可 轻轻清除牙齿和牙床上的牙菌斑和碎屑。该设计包括多种功能，以确保舒适性 在日常护理过程中的安全性，包括嵌入式传感器，以调整刷毛运动的强度和速度。 使用信息通过LCD显示屏无线传输到监控护理状态的护理人员 基站充值和清洗。这些定期报告将通过防止中断 日常卫生。通过为弱势群体提供技术先进但实用的牙科护理系统 在家庭或护理设施中使用的人口，定期、有效的口腔卫生可以得到改善，降低风险 关于可预防的口腔疾病和治疗的需要。该第二阶段SBIR将评估该系统的有效性 为患者和护理人员提供有效的、免提的常规口腔卫生护理方法，以改善 提高生活质量，减少努力和困难，并保持对推荐护理的坚持。随机化 受控评价将使用半结构化访谈和在以下时间收集的观察数据完成 110名中度口腔卫生残障人士、家庭照顾者和/或专业照顾者。