The limitations of the study include the small number of study participants and the absence of a sham-placebo control group which prevented blinding. This means it is possible that the changes observed with HIRREM, could be due to a placebo effect. In addition, because HIRREM therapy involves social interaction and relaxation, there may be other non-specific mechanisms for improvement, in addition to the tonal mirroring. Although the researchers believe that the degree of improvement and length of time it persisted (for four weeks after the last session) suggests real change through HIRREM, Tegeler is planning a larger clinical trial using a sham placebo, to confirm the HIRREM effect and further explore the technology.
Co-authors in the study are Sandhya R. Kumar, M.D., Dave Conklin, MS III, Dana P. Turner, MSPH, Catherine L. Tegeler, B.S., and Tim T. Houle, M.D., of Wake Forest Baptist Medical Center, Brian C. Fidali, MS I, now of Weill Cornell Medical College of Cornell University, as well as Lee Gerdes and Sung W. Lee, M.D., of Brain State Technologies, LLC.
Disclosure: The Wake Forest faculty has no conflicts of interest, no direct financial relationships or positions with Brain State Technologies, LLC, which owns the HIRREM technology. Sung Lee, M.D., is research coordinator for Brain State Technologies, LLC and Lee. E. Gerdes is the inventor of the HIRREM technology and CEO of Brain State Technologies, LLC.
Wake Forest Baptist Medical Center is a fully integrated academic medical center located in Winston-Salem, North Carolina. The institution comprises the medical education and research components of Wake Forest School of Medicine, the integrated clinical structure and consumer brand Wake Forest Baptist Health, which includes North Carolina B
|SOURCE Wake Forest Baptist Medical Center|
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