Incubator-based active noise control system validation in realistic NICU environment

真实 NICU 环境中基于培养箱的主动噪声控制系统验证

• 批准号: 9907499
• 负责人: George Hutchinson
• 金额: $ 22.16万
• 依托单位: INVICTUS MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-05 至 2020-03-05
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9907499
• 关键词: Acute; Address; Adult; Air; Attenuated; Awareness; Caring; Clinical; Clinical Research; Cognitive; Control Groups; Controlled Environment; Data; Development; Diagnosis-Related Groups; Ear; Education; Ensure; Environment; Exposure to; Health; Health Care Costs; Healthcare; Incubators; Infant; Institution; Language; Language Disorders; Lead; Length of Stay; Life; Link; Literature; Measurement; Methods; Neonatal Intensive Care Units; Noise; Outcome; Outcome Study; Patient Monitoring; Patients; Phase; Positioning Attribute; Premature Infant; Procedures; Production; Pump; Reporting; Research; Savings; Secondary to; Short Interspersed Nucleotide Elements; Signal Transduction; Speed; Stress; Syringes; System; Techniques; Technology; Telephone; Testing; Time; Validation; Ventilator; Voice; Weight Gain; Work; attenuation; base; biological adaptation to stress; clinical efficacy; commercialization; design; efficacy study; hazard; health care delivery; hearing impairment; high risk infant; improved; novel; perinatal brain; phase 2 study; preservation; pressure; prototype; sleep quality; sound

The aural stimulation of the hospitalized infant in the neonatal intensive care unit (NICU) from alarms, ventilators, phones, conversations, and air handling system is linked to a myriad of problems, both acute and long-term. The stress resulting from the noise has a negative effect on vital signs, weight gain, and quality of sleep in the short term and in the long term with hearing loss and language deficit. Efforts to reduce sound levels in the NICU such as staff education have not been reported in the literature to be successful. A non-contact means of attenuating sound pressure levels for vulnerable infants in the NICU should reduce these harmful nosocomial effects. A prototype active noise control (ANC) system for use in an incubator has been developed that simultaneously permits parental or clinician voices to be passed through to the infant within. This voice pass-through feature is essential to ensure proper vocal development. Successful deployment of this incubator-based ANC system would address the clinical problems associated with excess noise while not causing a problem due to lack of adult words and conversation turns. This Phase I work is a preliminary study to ensure that the ANC system was able to attenuate recorded NICU noises and will determine if a Phase II clinical outcome study is warranted and will improve the likelihood of a successful clinical study. Upon a successful completion of Phase I, a Phase II study would seek to demonstrate the clinical efficacy under actual conditions with patients. The demonstration of clinical efficacy is necessary for a successful commercial launch. The proposed Phase I research is designed to determine whether a novel ANC system can attenuate sound in an incubator when exposed to simulated NICU sounds. While a prototype system has been developed that can attenuate sine wave signals, it will be necessary to validate that the ANC system can work effectively with simulated NICU noise from recordings in a controlled environment. The noises will include sounds found in a NICU environment including alarms, ventilator sounds, conversation, telephone rings, overhead announcements, and other factors.

新生儿重症监护病房（NICU）住院婴儿的听觉刺激 从警报器，空调器，电话，谈话，和空气处理系统是连接到无数的 这些问题，无论是尖锐的还是长期的。噪音造成的压力有负面影响 对生命体征、体重增加和睡眠质量的短期和长期影响 听力损失和语言缺陷。努力降低新生儿重症监护室的声级，例如工作人员 在文献中没有报道教育是成功的。一种非接触式的 对NICU中的脆弱婴儿进行声压级衰减， 有害的医院效应。本发明公开了一种用于有源噪声控制（ANC）系统的原型， 已经开发了一种孵化器，其同时允许父母或临床医生的声音被 传递给了婴儿此语音直通功能对于确保 适当的发声发展。这种基于培养箱的ANC系统的成功部署将 解决与过量噪声相关的临床问题，同时不会因 缺乏成人的话语和谈话的转折点。 第一阶段的工作是一项初步研究，以确保ANC系统能够衰减 记录NICU噪音，并将确定是否需要进行II期临床结局研究， 将提高临床研究成功的可能性。在第一阶段成功完成后， II期研究将寻求在患者的实际情况下证明临床疗效。 临床疗效的证明是成功上市的必要条件。 拟议的第一阶段研究旨在确定一种新型ANC系统是否可以 当暴露于模拟的NICU声音时，衰减培养箱中的声音。当一个原型系统 已经开发了可以衰减正弦波信号的方法，因此有必要验证 ANC系统可以在受控环境中有效地使用来自记录的模拟NICU噪声 环境噪声将包括在NICU环境中发现的声音，包括警报， 通风机声音、谈话、电话铃声、头顶广播和其他因素。

项目成果

Incubator-based active noise control device: comparison to ear covers and noise reduction zone quantification.

• DOI: 10.1038/s41390-023-02708-w
• 发表时间: 2023-11
• 期刊: PEDIATRIC RESEARCH
• 影响因子: 3.6
• 作者: Hutchinson, George M. M.;Wilson, Preston S. S.;Sommerfeldt, Scott;Ahmad, Kaashif
• 通讯作者: Ahmad, Kaashif