title: Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia.
abstract: Effective noninvasive interventions for insomnia are needed. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM™) is a noninvasive, electroencephalography (EEG)-based method to facilitate greater client-unique, autocalibrated improvements of balance and harmony in cortical neural oscillations. This study explores using HIRREM for insomnia. Twenty subjects, with an Insomnia Severity Index (ISI) score of ≥15 (14 women, mean age 45.4, mean ISI 18.6), were enrolled in this randomized, unblinded, wait-list control, crossover, superiority study. Subjects were randomized to receive 8-12 HIRREM sessions over 3 weeks, plus usual care (HUC), or usual care alone (UC). Pre- and post-HIRREM data collection included ISI (primary outcome), and many secondary, exploratory measures (CES-D, SF-36, HR, BP, neurocognitive testing, and VAS scales). The UC group later crossed over to receive HIRREM. ISI was also repeated 4-6 weeks post-HIRREM. All subjects completed the primary intervention period. Analysis for differential change of ISI in the initial intervention period for HUC versus UC showed a drop of 10.3 points (95% CI: -13.7 to -6.9, P < 0.0001, standardized effect size of 2.68). Key secondary outcomes included statistically identical differential change for the crossed-over UC group, and persistence of the effect on the ISI up to > 4 weeks post-HIRREM. Differential change in the HUC group was also statistically significant for CES-D (-8.8, 95% CI: -17.5 to -0.1, P = 0.047), but other exploratory outcomes were not statistically significant. For all receiving HIRREM (n = 19), decreased high-frequency total power was seen in the bilateral temporal lobes. No adverse events were seen. This pilot clinical trial, the first using HIRREM as an intervention, suggests that HIRREM is feasible and effective for individuals having moderate-to-severe insomnia, with clinically relevant, statistically significant benefits based on differential change in the ISI. Effects persisted for 4 weeks after completion of HIRREM. Larger controlled clinical trials are warranted.
authors.affiliation: Department of Neurology, Wake Forest School of Medicine Winston-Salem, North Carolina.
authors.forename: Charles H
authors.initials: CH
authors.lastname: Tegeler
authors.forename: Sandhya R
authors.initials: SR
authors.lastname: Kumar
authors.forename: Dave
authors.initials: D
authors.lastname: Conklin
authors.forename: Sung W
authors.initials: SW
authors.lastname: Lee
authors.forename: Lee
authors.initials: L
authors.lastname: Gerdes
authors.forename: Dana P
authors.initials: DP
authors.lastname: Turner
authors.forename: Catherine L
authors.initials: CL
authors.lastname: Tegeler
authors.forename: Brian
authors.initials: B
authors.lastname: C Fidali
authors.forename: Tim T
authors.initials: TT
authors.lastname: Houle