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.

Project Narrative 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.