Feasibility of Frontal Cerebral Hypothermia as a Treatment for Insomnia

描述（由申请人提供）：流行病学研究报告的失眠症患病率为美国人口的10-40%（3000万至1.2亿人），全球报告的比例相似。催眠药是治疗失眠的主要药物，每年产生约50亿美元的收入，但严重的不良事件限制了它们的使用。失眠症的行为治疗是有效的，但所涉及的专业培训和技术只有一小部分失眠症患者可以使用。因此，对一种安全、有效、无创、理想、非药物治疗失眠的方法存在着巨大的市场需求。局部脑热疗法（RCTT）是一种旨在逆转失眠患者中枢神经系统亢奋的干预措施，旨在满足这一需求。Eric a . Nofzinger，医学博士，Cerjve公司总裁兼首席执行官，匹兹堡大学精神病学教授和睡眠神经成像研究项目主任，发明了一种新的医疗设备来提供RCTT。Cerjve Inc.是一家匹兹堡大学的分拆公司，由Nofzinger博士创立，授权，开发和商业化该技术。这项STTR提案代表了Cerjve公司在小型临床试验中测试该设备可行性的研究组成部分。该提案将利用匹兹堡大学Daniel J. Buysse医学博士指导下的世界级睡眠中心的资源，以及Cerjve Inc.的数据管理、统计和智力资源，包括其创始人兼首席执行官Nofzinger博士。该装置本身包括一个覆盖在大脑前额叶皮层上的头皮的热垫，一个温度控制浴，以及一个带塑料管的泵，用于将热流体从浴液循环到热垫。它代表了第一种使用RCTT技术治疗失眠的非侵入性医疗设备。这个STTR项目的长期目标是确定这种医疗设备在治疗失眠方面的可行性。该I期提案的目的是提供可行性数据，以开始解决RCTT治疗失眠有效且耐受性良好的假设。10名失眠患者将接受3种不同温度设置的设备和无设备控制的治疗。为了控制适应效应，治疗顺序将在受试者之间随机化。如果在I期建议中注意到提示效应，则将建议进行更大规模的II期研究，以使用该设备进行更大规模的验证性临床试验。为Cerjve开发的财务预测表明，该设备有望获得的市场空间将为该公司带来巨大的商业机会。公共卫生相关性：流行病学研究报告的失眠症患病率及相关发病率在美国人口中占10-40%。现有的治疗方法有明显的不良事件或没有广泛使用。一种安全、有效的治疗失眠的医疗设备的可用性，如在第一阶段STTR申请中提出的，预计将对公共卫生产生重大影响。

DESCRIPTION (provided by applicant): The prevalence of insomnia reported in epidemiologic studies 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, generating revenues of about $5 billion/year, yet significant adverse events limit their use. Behavioral treatments for insomnia are efficacious, but the specialized training and techniques involved are available to only a minute fraction of insomnia sufferers. Therefore, a large market need exists for a safe, effective, non-invasive, desirable, non-pharmaceutical treatment for insomnia. Regional cerebral thermal therapy (RCTT), an intervention designed to reverse the hyperarousal in the central nervous system found in insomnia patients, is proposed to meet this need. Eric A. Nofzinger, M.D., President and CEO, Cerjve Inc., Professor of Psychiatry and Director of the Sleep Neuroimaging Research Program at the University of Pittsburgh, has invented a novel medical device to deliver RCTT. Cerjve Inc. is a University of Pittsburgh spin off company, founded by Dr. Nofzinger, to license, develop and commercialize this technology. This STTR proposal represents a research component of Cerjve Inc. to test the feasibility of the device in a small clinical trial. The proposal will utilize the resources of a world-class sleep center under the direction of Daniel J. Buysse, M.D. at the University of Pittsburgh as well as the data management, statistical, and intellectual resources of Cerjve Inc., including its founder and CEO, Dr. Nofzinger. The device itself consists of a thermal pad that covers the scalp over the prefrontal cortex of the brain, a temperature controlling bath, and a pump with plastic tubing for circulating the thermal fluids from the bath to the thermal pad. It represents a first in kind, non-invasive, medical device that uses the RCTT technology for the treatment of insomnia. The long-term goal of this STTR Project is to determine the feasibility of this medical device in the treatment of insomnia. The aims for this Phase I proposal are to provide feasibility data to begin to address the hypothesis that RCTT is effective and well tolerated in the treatment of insomnia. Ten insomnia patients will receive treatment with 3 different temperature settings of the device and a no device control. To control for adaptation effects, the order of treatments will be randomized across subjects. If suggestive effects are noted in this Phase I proposal, a larger Phase II study will be proposed to conduct a larger confirmatory clinical trial using the device. Financial projections developed for Cerjve suggest a large commercial opportunity for the company primarily driven by the market space this device would be expected to capture. PUBLIC HEALTH RELEVANCE: The prevalence of insomnia, with associated morbidity, that is reported in epidemiologic studies 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 medical device for the treatment of insomnia such as that proposed in this Phase I STTR application would be expected to have a significant public health impact.