Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia

Charles H Tegeler, Sandhya R Kumar, Dave Conklin, Sung W Lee, Lee Gerdes, Dana P Turner, Catherine L Tegeler, Brian C Fidali, Tim T Houle, Charles H Tegeler, Sandhya R Kumar, Dave Conklin, Sung W Lee, Lee Gerdes, Dana P Turner, Catherine L Tegeler, Brian C Fidali, Tim T Houle

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.

Keywords: Biofeedback; EEG; HIRREM; insomnia; neural oscillations.

Figures

Figure 1
Figure 1
Timelines for occurrence of specific activities in the two groups (HUC and UC).
Figure 2
Figure 2
Schematic of key components of the HIRREM intervention.
Figure 3
Figure 3
Subject recruitment and flow through the study.
Figure 4
Figure 4
Baseline and post-HIRREM Insomnia Severity Index (ISI) scores for usual care (UC) and HIRREM plus usual care (HUC) groups. Differential change: −10.3 (95% CI: −13.7 to −6.9), P < 0.0001.
Figure 5
Figure 5
Baseline to post-HIRREM changes in Insomnia Severity Index (ISI) scores for usual care (UC) and HIRREM plus usual care (HUC) groups after cross-over, with 4- to 6-week late follow-up ISI scores.
Figure 6
Figure 6
Tukey box plot of mean power (log transformed) in the high-frequency (23–36 Hz, “80”) range at the temporal locations (T3 and T4, averaged together), over the course of eight HIRREM sessions, n = 19 subjects.

References

    1. Adam K, Tomeny M, Oswald L. Physiological and psychological differences between good and poor sleepers. J. Psychiatr. Res. 1986;20:301–316.
    1. Armagan O, Tascioglu F, Oner C. Eletromyographic biofeedback in the treatment of the hemiplegic hand: a placebo-controlled study. Am. J. Phys. Med. Rehabil. 2003;82:856–861.
    1. Basta D, Rossi-Izquierdo M, Soto-Varela A, Greters ME, Bittar RS, Steinhagen-Thiessen E, et al. Efficacy of a vibrotactile neurofeedback training in stance and gait conditions for the treatment of balance deficits: a double-blind, placebo-controlled multicenter study. Otol. Neurotol. 2011;32:1492–1499.
    1. Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001;2:297–307.
    1. Bastien C, St-Jean G, Morin C, Turcotte I, Carrier J. Chronic psychophysiological insomnia: hyperarousal and/or inhibition deficits? An ERPs investigation. Sleep. 2008;31:887–898.
    1. Becerra J, Fernandez T, Harmony T, Caballero MI, Garcia F, Fernandez-Bouzas A, et al. Follow-up study of learning-disabled children treated with neurofeedback or placebo. Clin. EEG Neurosci. 2006;37:198–203.
    1. Bonnet MH, Arand DL. Heart rate variability in insomniacs and matched normal sleepers. Psychosom. Med. 1998;60:610–615.
    1. Bryant RA, Creamer M, O'Donnell M, Silove D, McFarlane AC. Sleep disturbance immediately prior to trauma predicts subsequent psychiatric disorder. Sleep. 2010;33:69–74.
    1. Budhiraja R, Roth T, Hudgel DW, Budhiraja P, Drake CL. Prevalance and polysomnographic correlates of insomnia comorbid with medical disorders. Sleep. 2011;34:859–867.
    1. Burgos I, Richter L, Klein T, Fiebich B, Feige B, Lieb K, et al. Increased nocturnal interleukin-6 excretion in patients with primary insomnia: a pilot study. Brain Behav. Immun. 2006;20:246–253.
    1. Charuvastra A, Cloitre M. Safe enough to sleep: sleep disruptions associated with trauma, posttraumatic stress, and anxiety in children and adolescents. Child Adolesc. Psychiatr. Clin. N. Am. 2009;18:877–891.
    1. Craig AD. Forebrain emotional asymmetry: a neuroanatomical basis? Trends Cogn. Sci. 2005;9:566–571.
    1. Devoto A, Manganelli S, Lucidi F, Lombardo C, Russo PM, Violani C. Quality of sleep and P300 amplitude in primary insomnia: a preliminary study. Sleep. 2005;28:859–863.
    1. Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995;18:425–432.
    1. Goldberger AL, Amaral LA, Glass L, Hausdorff JM, Ivanov PC, Mark RG, et al. PhysioBank, PhysioToolkit, and PhysioNet: components of a new research resource for complex physiologic signals. Circulation. 2000;101:E215–E220.
    1. Gumenyuk V, Roth T, Korzyukov O, Jefferson C, Kick A, Spear L, et al. Shift work sleep disorder is associated with an attenuated brain response of sensory memory and an increased response to novelty: an ERP study. Sleep. 2010;33:703–713.
    1. Henderson RJ, Hart MG, Lal SK, Hunyor SN. The effect of home training with direct blood pressure biofeedback of hypertensives: a placebo-controlled study. J. Hypertens. 1998;16:771–778.
    1. Hunyor SN, Henderson RJ, Lal SK, Carter NL, Kobler H, Jones M, et al. Placebo-controlled biofeedback blood pressure effect in hypertensive humans. Hypertension. 1997;29:1225–1231.
    1. Jasper HH. The ten twenty electrode system of the International Federation. Electroencephalogr. Clin. Neurophysiol. 1958;10:371–375.
    1. Jaussent I, Bouyer J, Ancelin ML, Akbaraly T, Peres K, Ritchie K, et al. Insomnia and daytime sleepiness are risk factors for depressive symptoms in the elderly. Sleep. 2011;34:1103–1110.
    1. Kobayashi I, Boarts JM, Delahanty DL. Polysomnographically measured sleep abnormalities in PTSD: a meta-analytic review. Psychophysiology. 2007;44:660–669.
    1. Krueger JM, Rector DM, Roy S, Van Dongen HP, Belenky G, Panksepp J. Sleep as a fundamental property of neuronal assemblies. Nat. Rev. Neurosci. 2008;9:910–919.
    1. Kuppermann M, Lubeck DP, Mazonson PD, Patrick DL, Stewart AL, Buesching DP, et al. Sleep problems and their correlates in a working population. J. Gen. Intern. Med. 1995;10:25–32.
    1. Laugsand LE, Vatten LJ, Platou C, Janszky I. Insomnia and the risk of acute myocardial infarction: a population study. Circulation. 2011;124:2073–2081.
    1. McCall WV, Blocker JN, D'Agostino R, Kimball J, Boggs N, Lasater B, et al. Insomnia severity is an indicator of suicidal ideation during a depression clinical trial. Sleep Med. 2010;11:822–827.
    1. Monroe LJ. Psychological and physiological differences between good and poor sleepers. J. Abnorm. Psychol. 1967;72:255–264.
    1. Nicassio PM, Boylan MB, McCabe TG. Progressive relaxation, EMG biofeedback and biofeedback placebo in the treatment of sleep-onset insomnia. Br. J. Med. Psychol. 1982;55:159–166.
    1. Nofzinger EA, Buysse DJ, Germain A, Price JC, Miewald JM, Kupfer DJ. Functional neuroimaging evidence for hyperarousal in insomnia. Am. J. Psychiatry. 2004;161:2126–2129.
    1. Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med. Rev. 2002;6:97–111.
    1. Ohayon MM, Roth T. Place of chronic insomnia in the course of depressive and anxiety disorders. J. Psychiatr. Res. 2003;37:9–15.
    1. Ohayon MM, Caulet M, Lemoine P. Comorbidity of mental and insomnia disorders in the general population. Compr. Psychiatry. 1998;39:185–197.
    1. Oostenveld R, Praamstra P. The five percent electrode system for high-resolution EEG and ERP measurements. Clin. Neurophysiol. 2001;112:713–719.
    1. Perlis ML, Giles DE, Mendelson WB, Bootzin RR, Wyatt JK. Psychophysiological insomnia: the behavioural model and a neurocognitive perspective. J. Sleep Res. 1997;6:179–188.
    1. Perlis ML, Merica H, Smith MT, Giles DE. Beta EEG activity and insomnia. Sleep Med. Rev. 2001a;5:365–376.
    1. Perlis ML, Smith MT, Orff H, Andrews P, Giles DE. Beta/gamma activity in patients with insomnia and in good sleeper controls. Sleep. 2001b;24:110–117.
    1. Pigeon WR, Cerulli C, Richards H, He H, Perlis M, Caine E. Sleep disturbances and their association with mental health among women exposed to intimate partner violence. J. Womens Health (Larchmt.) 2011;20:1923–1929.
    1. Rao SS, Seaton K, Miller M, Brown K, Nygaard I, Stumbo P, et al. Randomized controlled trial of biofeedback, sham feedback, and standard therapy for dyssynergic defecation. Clin. Gastroenterol. Hepatol. 2007;5:331–338.
    1. Reid KJ, Zee PC. Circadian rhythm disorders. Semin. Neurol. 2009;29:393–405.
    1. Riemann D, Kloepfer C, Berger M. Functional and structural brain alterations in insomnia: implications for pathophysiology. Eur. J. Neurosci. 2009;29:1754–1760.
    1. Saper CB, Scammell TE, Lu J. Hypothalamic regulation of sleep and circadian rhythms. Nature. 2005;437:1257–1263.
    1. Sheer FA, Hilton MF, Mantzoros CS, Shea SA. Adverse metabolic and cardiovascular consequences of circadian misalignment. Proc. Natl. Acad. Sci. USA. 2009;106:4453–4458.
    1. Simon GE, VonKorff M. Prevalence, burden, and treatment of insomnia in primary care. Am. J. Psychiatry. 1997;154:1417–1423.
    1. Spoormaker VI, Montgomery P. Disturbed sleep in post-traumatic stress disorder: secondary symptom or core feature? Sleep Med. Rev. 2008;12:169–184.
    1. Steiger A. Neurochemical regulation of sleep. J. Psychiatr. Res. 2007;41:537–552.
    1. Taylor DJ, Lichstein KL, Durrence HH, Reidel BW, Bush AJ. Epidemiology of insomnia, depression, and anxiety. Sleep. 2005;28:1457–1464.
    1. Vgontzas AN, Bixler EO, Lin HM, Prolo P, Mastorakos G, Vela-Bueno A, et al. Chronic insomnia is associated with nyctohemeral activation of the hypothalamic-pituitary-adrenal axis: clinical implications. J. Clin. Endocrinol. Metab. 2001;86:3787–3794.
    1. Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Basta M, et al. Insomnia with short sleep duration and mortality: the Penn State cohort. Sleep. 2010;33:1159–1164.
    1. Yang CM, Lo HS. ERP evidence of enhanced excitatory and reduced inhibitory processes of auditory stimuli during sleep in patients with primary insomnia. Sleep. 2007;30:585–592.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit