Artwork by Stan Harmon (www.stanharmonglassart.com)
Overview of Research Projects
In 2011, the Department of Neurology at Wake Forest School of Medicine (WFSM) launched an effort to create a HIRREM research program. The primary goals were to evaluate the effects of HIRREM, identify which symptoms or conditions may benefit, and define the magnitude of any benefit using accepted scientific methods. With the help of many collaborators, the second goal was to better understand the mechanism(s) of action for HIRREM. A study team was formed, and the program has experienced steady growth in facilities, personnel, and projects.
This section of the webpage addresses current, pending and planned, and completed research projects, as well as grants and funding.
The HIRREM research projects referred to on these pages are all done with review and approval by the Wake Forest University Health Sciences Institutional Review Board (IRB). As of August, 2016, over 400 participants have enrolled in one of five research projects. The first project completed was a randomized, wait-list controlled, crossover pilot study comparing HIRREM plus usual care to usual care alone for insomnia. The second project completed was a randomized, placebo-controlled pilot study comparing HIRREM to a sham placebo for episodic migraine.
An open label Developmental Study is ongoing, in order to evaluate the feasibility of HIRREM, as well as the effect size, and the effect on autonomic function, for a variety of other symptoms and conditions. Results from this study are being used as pilot data for both the transition to controlled studies in specific conditions, and for applications for outside funding for the same.
A single site, randomized, single blind, placebo-controlled study is underway to compare the effects of HIRREM, compared to placebo, for those with symptoms of insomnia. Outcome measures also include pre- and post-intervention blood pressure and heart rate recordings to evaluate autonomic cardiovascular control. The primary source of support for the work outlined above has been a series of grants from The Susanne Marcus Collins Foundation, Inc.
A single site, open label feasibility trial is underway to evaluate the use of HIRREM as an adjunct for 10 military service members with a diagnosis of PTSD or symptoms of traumatic stress, with or without mild TBI, who meet protocol exclusion criteria for current medications. Funding for this project was made possible through the Joint Capability Technology Demonstration Program within the Office of the Under Secretary of Defense (Acquisition, Technology, and Logistics) via a contract with the U.S. Special Operations Command.