Feasibility of Frontal Cerebral Hypothermia as a Treatment for Insomnia

额叶脑低温治疗失眠的可行性

• 批准号: 7748869
• 负责人: ERIC A. NOFZINGER
• 金额: $ 19.75万
• 依托单位: CEREVE, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-09 至 2010-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7748869
• 关键词: Address; Adverse event; Arousal; Bathing; Behavior Therapy; Body Temperature; Brain; Cerebrum; Chronic; Clinical Management; Clinical Trials; Confusional Arousals; Data; Dependence; Devices; Doctor of Medicine; Dose; Electroencephalography; Epidemiologic Studies; Feasibility Studies; Future; Goals; Home environment; Intervention; Licensing; Liquid substance; Maintenance; Marketing; Measures; Medical; Medical Device; Memory Loss; Metabolic; Metabolism; Methods; Modality; Modeling; Morbidity - disease rate; Neuraxis; Neurological observations; Patients; Penetration; Pharmacologic Substance; Phase; Phase II Clinical Trials; Plastics; Population; Prefrontal Cortex; Prevalence; Price; Psychiatry; Public Health; Pump; Randomized; Reporting; Research; Research Design; Resources; Sales; Sample Size; Scalp structure; Sleep; Sleeplessness; Slow-Wave Sleep; Small Business Technology Transfer Research; Solutions; Somnambulism; Statistical Data Interpretation; Stroke; Study Subject; Technology; Temperature; Testing; Therapeutic; Therapeutic Intervention; Training; Training Technics; Transient Insomnia; Traumatic Brain Injury; United States; Universities; addiction; clinical efficacy; commercialization; cost; data management; hypnotic; meetings; middle age; natural hypothermia; nervous system disorder; neuroimaging; novel; novel therapeutics; professor; programs; public health relevance; sedative; therapy design

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.

描述（由申请人提供）：流行病学研究中报道的失眠症的患病率范围从美国的10-40％的人口（30至1.2亿人口）范围内报道，全球范围内报告了相似的率。催眠药是失眠症的主要医疗治疗，每年的收入约为50亿美元，但重大不良事件限制了其使用。失眠的行为治疗是有效的，但是仅一分钟的失眠症患者只能使用专门的培训和技术。因此，存在巨大的市场需求，即对失眠症的安全，有效，非侵入性，理想，非药物治疗。提出了一种旨在扭转失眠症患者中枢神经系统中的高音的干预措施，旨在满足这种需求。 Eric A. Nofzinger，医学博士，匹兹堡大学精神病学教授兼Sleep Neurotimaging Research Programe教授兼首席执行官Cerjve Inc.医学博士，已经发明了一种新颖的医疗设备来提供RCTT。 Cerjve Inc.是由Nofzinger博士创立的匹兹堡大学旋转公司，以许可，开发和商业化这项技术。该STTR提案代表了Cerjve Inc.的研究组成部分，用于在小型临床试验中测试该设备的可行性。该提案将在匹兹堡大学医学博士的丹尼尔·J·布伊斯（Daniel J.该设备本身由一个热垫组成，该热垫覆盖了大脑前额叶皮层上的头皮，温度控制浴以及带有塑料管的泵，可将热流体从浴缸循环到热垫。它代表了使用RCTT技术来治疗失眠症的第一类，非侵入性的医疗设备。该STTR项目的长期目标是确定该医疗设备在治疗失眠症中的可行性。该阶段I提案的目的是提供可行性数据，以开始解决RCTT有效且在失眠治疗方面良好耐受性的假设。十名失眠症患者将接受设备的3种不同温度设置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分配。如果在此I阶段提案中指出了暗示性效应，则将提出一项较大的II期研究，以使用该设备进行更大的验证性临床试验。为Cerjve开发的财务预测表明，该设备将有望捕获的主要由市场空间驱动的公司有很大的商业机会。公共卫生相关性：失眠症与相关的发病率的流行率在流行病学研究中报道了美国10-40％的美国人口。可用的治疗有重大的不良事件或不可广泛的可用。预计将有一种安全有效的医疗设备用于治疗失眠症，例如I阶段ISTTR应用中提出的治疗，将对公共卫生产生重大的影响。

项目成果

A novel forehead temperature-regulating device for insomnia: a randomized clinical trial.

一种治疗失眠的新型前额温度调节装置：一项随机临床试验。

• DOI: 10.1093/sleep/zsy045
• 发表时间: 2018
• 期刊: Sleep
• 影响因子: 5.6
• 作者: Roth,Thomas;Mayleben,David;Feldman,Neil;Lankford,Alan;Grant,Timothy;Nofzinger,Eric
• 通讯作者: Nofzinger,Eric