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：
8260286
负责人：
ERIC A. NOFZINGER
金额：
$ 86.92万
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/8260286
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 public health relevance 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）：失眠症的患病率在美国的10-40％的人口（30至1.2亿人口）中，全球范围内报告相似。催眠药是失眠症的主要医疗，但重大不良事件限制了它们的使用。失眠的行为治疗是有效的，但是提供这种治疗所需的劳动力和费用很难扩展到广泛的失眠症患者中。存在巨大的市场需求，是一种安全，有效，非侵入性，基于家庭的，非药物治疗的失眠症。提议满足这种需求。 Cerjve由匹兹堡大学神经生物学神经生物学的思想领导者Eric Nofzinger MD创立，以使这种设备商业化。一项由Respironics Research Foundation资助的大脑成像研究证实，该设备在睡眠过程中降低了失眠症患者慢波睡眠的额额超代谢。 I期SBIR研究表明，该设备在失眠症患者的睡眠潜伏期和睡眠效率的脑电睡眠度量方面产生了依赖性改善。现在，此II期SBIR续订旨在进行工业设计和机械工程研究，以开发可商业化的家庭设备，然后对该设备对失眠症患者的睡眠潜伏期和睡眠效率的影响进行确认分析。与Cerjve合作，工业设计将由Acorn产品开发（其领域的领导者）通过智能设计和机械工程进行。在Nofzinger博士的指导下，Cerjve将监督多中心临床试验。各个地点将包括亚特兰大的神经病人（罗素·罗森伯格（Russell Rosenberg）和圣地亚哥的太平洋睡眠医学（董事米尔顿·埃曼（Milton Erman））。集中的脑电图评分将在汤姆·罗斯（Tom Roth）博士的监督下进行。 100名失眠患者将进入随机，交叉，设备控制，多中心临床试验。所有患者将接受2个基线夜晚的脑电图睡眠研究，然后在中性和主动装置状况下进行2晚，并在患者之间随机进行表现。如果确认性分析是积极的，则该SBIR项目的长期目标是将此设备商业化以治疗失眠。 Cerjve首席执行官Erica Rogers是一位经验丰富的医疗设备执行官Erica Rogers制定的商业化计划，这为该公司提供了很大的商业机会，这是由于失眠症市场的巨大未满足需求而驱动的。 II阶段SBIR的资金将为私人投资者和风险投资社区的这项工作补充并利用重大财务承诺。公共卫生相关性：失眠症的患病率范围为美国人口的10-40％。可用的治疗有重大的不良事件或不可广泛的可用。有效，有效的家庭医疗设备可用于治疗失眠症，例如在本阶段II阶段SBIR应用中提出的医疗设备将对公共卫生产生重大影响。