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 goals were to apply rigorous scientific research principles to evaluate the effects of HIRREM, what conditions might benefit, and the magnitude of any benefits. 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). The first project completed was a randomized, wait-list controlled, crossover pilot study comparing HIRREM plus usual care to usual care alone for insomnia (n = 20). The second project completed was a randomized, placebo-controlled pilot study comparing HIRREM to a sham placebo for episodic migraine (n = 30).
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 conditions. As of October 31, 2013, 125 subjects have been enrolled. Results of 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 placebo-controlled study for insomnia will begin enrolling in November 2013. Multiple other studies are being planned including projects for athletes with persisting post-concussion symptoms, women with hot flashes, military service members with PTSD, civilians with PTSD or TBI, and others. The primary source of support for this work has been a series of grants from The Susanne Marcus Collins Foundation, Inc.