High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) to relieve insomnia: A randomized, placebo-controlled clinical trial
This single site, randomized, placebo-controlled research trial will endeavor to determine whether the addition of HIRREM to usual care will improve insomnia symptoms based on changes in the ISI at two months following completion of the intervention, compared to placebo plus usual care. Up to 100 participants, age 18 or over, will be recruited. This study is designed to confirm results of prior work using a placebo control, a larger study sample, with a standard number of HIRREM sessions, while extending the primary outcome measure to two months following completion of the intervention, and the total follow-up period to four months following completion of HIRREM or placebo. Enrollment will begin in November, 2013.
Functional and physiological effects of high-resolution,
relational, resonance-based, electroencephalic mirroring (HIRREM) for
neurological, cardiovascular and psychophysiological disorders
Also known as the Developmental Study, the purpose of this exploratory study is to ascertain the functional and physiological effects of HIRREM as supplemental care in populations and individuals age 12 and older, with a variety of neurological, cardiovascular, and psychophysiological diseases. The scope of the conditions to be investigated is broad since it is the intention of this proposal to allow the recruitment of a wide variety of patients at the discretion of the investigators. One goal is to allow investigators to identify patient cohorts which would be desirable for further study, some of which may not be intuitively obvious, using such data as the basis for pursuit of additional disease-specific research projects, or funding opportunities. Such data, prospectively gathered in a carefully monitored clinical environment through this proposal, can serve as a foundation for the pursuit of future randomized controlled pilot studies, and eventually larger randomized controlled clinical trials.
As of October 31, 2013, 125 subjects have now enrolled, and have provided the data for analysis of case series of participants with post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), hot flashes, and postural orthostatic tachycardia syndrome (POTS). It has also allowed an opportunity for analysis of brain patterns before and after HIRREM, correlations with downstream autonomic function as measured with heart rate variability (HRV), and correlations at baseline between brain pattern and HRV. This has resulted in the submission of a series of abstracts, with presentation of posters at national meetings (see Presentations and Publications). The data have also formed the basis for several grant applications, and plans for focused, controlled research projects.