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 在第二阶段 SBIR 项目中，ASTER Labs 将增强免提自动口腔卫生设备，其形式为 在第一阶段研究中设计并成功测试和评估的舒适吹嘴 对于有口腔卫生障碍的人及其护理人员，然后调查该设备在以下方面的功效 减少牙菌斑，减轻负担，从而提高生活质量。很多患有神经系统疾病的人， 神经肌肉和发育障碍，包括那些遭受身体伤害或震颤的人，正处于 与其他人相比，口腔健康状况不佳、龋齿、牙周病和软组织病理的风险更高 无残疾。大约 3200 万美国残疾人在日常生活中遇到障碍， 由于抓握、肌肉控制、运动范围和 灵活性降低。许多人的独立性下降，需要护理人员协助进行日常牙科治疗 关心。这些护理人员表示，由于缺乏培训、时间、 或对管理口腔卫生护理复杂性的信心。对当前设备进行调查以帮助完成这些任务 残疾人仅展示有限的手动解决方案，包括保持嘴巴张开的道具和修改 牙刷柄。目前的电动牙刷需要手动控制。日常卫生不当会促进口腔 残疾人患有疾病，由于财政有限、能力不足，他们在获得牙科护理方面面临障碍 医疗补助覆盖范围以及接受过残疾护理培训的专业人员数量有限。重大未满足的需求 旨在通过安全、自动、负担得起的、 促进日常牙齿护理并减轻负担的实用解决方案。为了解决这个问题，ASTER Labs, Inc. 开发了一种有效且新颖的原型免提自动系统，以简化日常口腔卫生 关心。该设备在灵活的咬嘴中使用动力驱动的移动刷毛，只需将其插入嘴中即可 轻轻去除牙齿和牙龈上的牙菌斑和碎屑。该设计包含多项功能以确保舒适度 日常护理期间的安全性，包括用于调节刷毛运动强度和速度的嵌入式传感器。 使用信息无线传输给护理人员，通过 LCD 显示屏监控护理状态 充电和清洁基站。这些定期报告将通过防止干扰来促进遵守 日常卫生。通过为这个弱势群体提供技术先进但实用的牙科护理系统 人群在家中或护理机构中使用，可以改善定期、有效的口腔卫生，降低风险 可预防的口腔疾病和治疗需求。该 II 期 SBIR 将评估该系统的功效 为患者和护理人员提供有效的免提日常口腔卫生护理方法，以改善 生活质量，减少努力和困难，并坚持遵守建议的护理。随机化 将使用半结构化访谈和收集的观察数据来完成受控评价 110 名患有中度口腔卫生障碍的人、家庭护理人员和/或专业护理人员。