Frontal Cerebral Hypothermia as a Treatment for Insomnia

额叶脑低温疗法治疗失眠

基本信息

批准号：
8122592
负责人：
ERIC A. NOFZINGER
金额：
$ 115.63万
依托单位：
CEREVE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-09 至 2013-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8122592
关键词：
Adverse event Behavior Therapy Brain Brain imaging Capital Cerebrum Chronic Insomnia Clinical Trials Collaborations Communities Data Development Device Designs Devices Doctor of Philosophy Dose Electroencephalography Engineering Feasibility Studies Foundations Funding Genetic Crossing Over Goals Home environment Human Individual Intervention Labor Forces Legal patent Liquid substance Marketing Measures Mechanics Medical Medical Device Medicine Metabolic Methods Multi-Institutional Clinical Trial Neuraxis Neurobiology Outcome Measure Patients Penetration Phase Placebos Population Prefrontal Cortex Prevalence Price Public Health Pump Randomized Reporting Research Research Design Safety Sales Sample Size Scalp structure Site Sleep Sleeplessness Slow-Wave Sleep Small Business Innovation Research Grant Study Subject Supervision Temperature Transient Insomnia United States Universities Work base commercialization cost cost effective design experience hypnotic meetings middle age natural hypothermia neuroimaging novel therapeutics phase 1 study product development prototype sedative therapy design

项目摘要

DESCRIPTION (provided by applicant): The prevalence of insomnia ranges from 10-40% of the population in the United States (30 to 120 million people) with similar rates reported worldwide. Hypnotics are the primary medical treatment for insomnia, yet significant adverse events limit their use. Behavioral treatments for insomnia are effective, but the labor force and expense required to deliver this treatment are difficult to scale to the broad population of insomnia sufferers. A large market need exists for a safe, effective, non-invasive, home-based, non-pharmaceutical treatment for insomnia. Frontal cerebral hypothermia, a patent-pending intervention designed to reverse the hyperarousal in the central nervous system found in insomnia patients, is proposed to meet this need. Cerjve was founded by Eric Nofzinger MD, a thought leader in the neurobiology of insomnia at the University of Pittsburgh, to commercialize such a device. A brain imaging study, funded by the Respironics Research Foundation, confirmed that the device reduced frontal hypermetabolism during sleep with associated increases in slow wave sleep in insomnia patients. A Phase I SBIR study demonstrated that the device produced dose- dependent improvements in EEG sleep measures of sleep latency and sleep efficiency in insomnia patients. Now, this Phase II SBIR renewal aims to perform industrial design and mechanical engineering research to develop a commercializable home-based device, then to perform a confirmatory analysis of the effects of the device on sleep latency and sleep efficiency in insomnia patients. In collaboration with Cerjve, industrial design will be performed by Smart Design and mechanical engineering by Acorn Product Development, leaders in their fields. Cerjve, under the direction of Dr. Nofzinger, will supervise the multi-center clinical trial. Individual sites will include Neurotrials in Atlanta (Russell Rosenberg, Director) and Pacific Sleep Medicine in San Diego (Milton Erman, Director). Centralized EEG sleep scoring will be performed under the supervision of Tom Roth, PhD. 100 insomnia patients will enter the randomized, cross-over, device-control, multi-center clinical trial. All patients will receive 2 baseline nights of EEG sleep studies, then 2 nights at both a neutral and active device condition, with order of presentation randomized across patients. The long-term goal of this SBIR Project, if confirmatory analyses are positive, is to commercialize this device for the treatment of insomnia. The commercialization plan developed by Cerjve's CEO, Erica Rogers, an experienced medical device executive, suggests a large commercial opportunity for the company driven by the large unmet need in the insomnia market. Funds from this Phase II SBIR will supplement and leverage significant financial commitments for this work from private investors and the venture capital community. PUBLIC HEALTH RELEVANCE: The prevalence of insomnia ranges from 10-40% of the United States population. Available treatments have significant adverse events or are not widely available. The availability of a safe, effective home-based medical device for the treatment of insomnia such as that proposed in this Phase II SBIR application would be expected to have a significant public health impact.

描述（由申请人提供）：美国 10% 至 40% 的人口（30 至 1.2 亿人）患有失眠症，全球范围内的发病率相似。安眠药是治疗失眠的主要药物，但严重的不良事件限制了其使用。失眠的行为治疗是有效的，但提供这种治疗所需的劳动力和费用很难扩展到广大失眠患者群体。对于安全、有效、非侵入性、家庭式、非药物的失眠治疗存在巨大的市场需求。额叶脑低温疗法是一种正在申请专利的干预措施，旨在逆转失眠患者中枢神经系统的过度兴奋，旨在满足这一需求。 Cerjve 由匹兹堡大学失眠神经生物学思想领袖 Eric Nofzinger MD 创立，旨在将这种设备商业化。由伟康研究基金会资助的一项脑成像研究证实，该设备减少了睡眠期间额叶的代谢亢进，从而增加了失眠患者的慢波睡眠。 I 期 SBIR 研究表明，该设备对失眠患者的睡眠潜伏期和睡眠效率的脑电图睡眠测量产生了剂量依赖性的改善。现在，第二期SBIR更新旨在进行工业设计和机械工程研究，开发一种可商业化的家用设备，然后对该设备对失眠患者睡眠潜伏期和睡眠效率的影响进行验证性分析。与 Cerjve 合作，工业设计将由 Smart Design 执行，机械工程将由各自领域的领导者 Acorn Product Development 执行。 Cerjve 将在 Nofzinger 博士的指导下监督多中心临床试验。个别地点将包括亚特兰大的神经试验中心（Russell Rosenberg，主任）和圣地亚哥的太平洋睡眠医学中心（Milton Erman，主任）。集中脑电图睡眠评分将在汤姆·罗斯博士的监督下进行。 100名失眠患者将进入随机、交叉、设备对照、多中心临床试验。所有患者将接受 2 晚的基线脑电图睡眠研究，然后在中性和活动设备条件下接受 2 晚的脑电图睡眠研究，并在患者之间随机化呈现顺序。如果验证性分析是积极的，该 SBIR 项目的长期目标是将这种治疗失眠的设备商业化。 Cerjve 的首席执行官 Erica Rogers（一位经验丰富的医疗器械高管）制定的商业化计划表明，在失眠市场大量未满足的需求的推动下，该公司面临着巨大的商业机会。第二阶段 SBIR 的资金将补充和利用私人投资者和风险投资界对这项工作的重大财务承诺。公共卫生相关性：失眠症的患病率在美国人口中占 10-40%。现有的治疗方法有严重的不良事件或尚未广泛使用。一种用于治疗失眠的安全、有效的家用医疗设备（例如本次 SBIR 申请中提出的设备）的可用性预计将对公共健康产生重大影响。