High‐resolution, relational, resonance‐based, electroencephalic mirroring (HIRREM) improves symptoms and autonomic function for insomnia: A randomized, placebo‐controlled clinical trial

Brain and Behavior

Lee Gerdes¹  Sean L. Simpson²  Charles H. Tegeler³  Catherine L. Tegeler³  Hossam A. Shaltout⁴  Sung W. Lee⁵ 

[1] Brain State Technologies, LLC Scottsdale AZ USA;Department of Biostatistics and Data Sciences WFSM Winston‐Salem NC USA;Department of Neurology Wake Forest School of Medicine (WFSM) Winston‐Salem NC USA;Hypertension and Vascular Research Center WFSM Winston‐Salem NC USA;University of Arizona School of Medicine Phoenix AZ USA;

关键词: acoustic neuromodulation;    allostasis;    autonomic;    closed‐loop neurotechnology;    HIRREM;    insomnia;   

DOI  :  10.1002/brb3.1826

来源: DOAJ

【 摘 要 】

Abstract Introduction Effective insomnia interventions that also address autonomic dysregulation are lacking. We evaluate high‐resolution, relational, resonance‐based, electroencephalic mirroring (HIRREM®), in a randomized, controlled clinical trial. HIRREM is a noninvasive, closed‐loop, allostatic, acoustic stimulation neurotechnology, to support self‐optimization of brain rhythms. Methods One hundred and seven adults (mean age 45.7, SD ± 5.6, 73 women), with Insomnia Severity Index (ISI) scores of ≥15, received ten, 90‐min sessions of HIRREM, with tones linked to brainwaves (LB, 56), or random tones not linked to brainwaves (NL, 51), as an active, sham placebo. Outcomes were obtained at enrollment (V1), 1–7 days (V2), 8–10 weeks (V3), and 16–18 weeks (V4) after intervention. Primary outcome was differential change in ISI from V1 to V3. Secondary measures assessed depression (BDI), anxiety (BAI), quality of life (EQ‐5D), and a sleep diary. Ten minute recordings of HR and BP allowed analysis of heart rate variability (HRV) and baroreflex sensitivity (BRS). Results Of 107 randomized, 101 completed the intervention. Intention‐to‐treat analysis (107) of change from V1 to V3 revealed a mean reduction of ISI in NL of −4.93 (SE ± 0.76) points, with additional, significant reduction of −2.05 points (0.74) in LB (total reduction of −6.98, p = .045). Additional reduction of −2.30 points (0.76) was still present in the LB at V4 (p = .058). Total ISI reduction from V1 to V4 was −5.90 points for NL and −7.93 points in LB. There were group differences (p < .05) for multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency. There were no serious adverse events. Conclusions Results of this controlled clinical trial showed clinically relevant reduction of insomnia symptoms with HIRREM, over, and above an active, sham control, with associated, durable improvement in autonomic cardiovascular regulation.

【 授权许可】

Unknown