Frontal Cerebral Hypothermia as a Treatment for Insomnia

描述(由申请人提供)： 失眠症的患病率在美国人口(3000万至1.2亿人)中从10%到40%不等，全球报告的失眠率相似。催眠药是治疗失眠的主要药物，但严重的不良反应限制了它们的使用。行为疗法治疗失眠是有效的，但提供这种治疗所需的劳动力和费用很难推广到广大失眠症患者。存在着对安全、有效、非侵入性、基于家庭的、非药物治疗失眠的巨大市场需求。额叶脑低温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觉醒，旨在满足这一需求。Cerjve是由匹兹堡大学失眠神经生物学的思想领袖埃里克·诺夫辛格医学博士创立的，目的是将这种设备商业化。由呼吸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的额叶高代谢，并相关地增加了失眠患者的慢波睡眠。一项第一阶段的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睡眠测量产生了剂量依赖性的改善。现在，这项第二阶段的SBIR更新旨在进行工业设计和机械工程研究，以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，工业设计将由各自领域的领先者橡子产品开发公司的Smart Design和机械工程执行。Cerjve将在Nofzinger博士的指导下，监督这项多中心临床试验。个别网站将包括亚特兰大的NeuroTrials(董事拉塞尔·罗森伯格)和圣地亚哥的太平洋睡眠医学(米尔顿·埃尔曼董事)。集中脑电睡眠评分将在Tom Roth博士的监督下进行。100名失眠症患者将进入随机、交叉、设备对照、多中心的临床试验。所有患者将接受两个基线晚上的脑电睡眠研究，然后在中性和活动设备条件下接受两个晚上，呈现顺序在患者中随机进行。如果验证性分析是肯定的，这个SBIR项目的长期目标是将这种治疗失眠的设备商业化。Cerjve首席执行官、经验丰富的医疗器械高管埃里卡·罗杰斯制定的商业化计划表明，在失眠市场巨大的未得到满足的需求的推动下，该公司将面临巨大的商业机会。这一第二阶段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： 失眠症的患病率从美国人口的10%到40%不等。现有的治疗方法有严重的不良事件，或者没有广泛使用。提供一种安全、有效的家用医疗设备来治疗失眠，如第二阶段SBIR应用中建议的那样，预计将对公众健康产生重大影响。

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.