Frontal Cerebral Hypothermia as a Treatment for Insomnia

描述（由申请人提供）： 失眠症的患病率范围为美国人口的10 - 40%（3000万至1.2亿人），全球报告的患病率相似。催眠药是治疗失眠的主要药物，但严重的不良事件限制了它们的使用。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的失眠患者群体。对于失眠症的安全、有效、非侵入性、基于家庭的非药物治疗存在巨大的市场需求。额叶脑低温，一个正在申请专利的干预措施，旨在扭转过度觉醒的中枢神经系统中发现失眠患者，提出了满足这一需求。Cerjve由匹兹堡大学失眠症神经生物学的思想领袖Eric Nofzinger医学博士创立，旨在将这种设备商业化。由Respironics研究基金会资助的一项脑成像研究证实，该设备在睡眠期间减少了额叶高代谢，并增加了失眠患者的慢波睡眠。一项I期SBIR研究表明，该设备在失眠患者的睡眠潜伏期和睡眠效率的EEG睡眠测量中产生了剂量依赖性改善。现在，第二阶段SBIR更新旨在进行工业设计和机械工程研究，以开发可商业化的家用设备，然后对该设备对失眠患者睡眠延迟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Acorn Product Development执行，Acorn Product Development是各自领域的领导者。Cerjve将在Nofzinger博士的指导下监督多中心临床试验。单个研究中心将包括亚特兰大的Neurotrials（Russell Rosenberg，主任）和圣地亚哥的Pacific Sleep Medicine（米尔顿Erman，主任）。将在Tom Roth博士的监督下进行集中EEG睡眠评分。100名失眠患者将进入随机、交叉、器械对照、多中心临床试验。所有患者将接受2个基线夜晚的EEG睡眠研究，然后在中性和有源器械条件下接受2个夜晚的EEG睡眠研究，患者之间的呈现顺序随机化。如果验证性分析结果为阳性，则该SBIR项目的长期目标是将该器械商业化用于治疗失眠。Cerjve首席执行官、经验丰富的医疗器械高管埃里卡罗杰斯（Erica Rogers）制定的商业化计划表明，失眠症市场巨大的未满足需求为该公司带来了巨大的商业机会。来自第二阶段SBIR的资金将补充和利用私人投资者和风险资本界对这项工作的重大财政承诺。 公共卫生相关性： 失眠的患病率范围从10 - 40%的美国人口。现有的治疗方法有显著的不良事件或不广泛使用。用于治疗失眠症的安全、有效的家用医疗器械（如本II期SBIR申请中提出的器械）的可用性预计将对公共卫生产生重大影响。

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.