0363 IN SUBJECTS WITH INSOMNIA, USE OF A CLOSED-LOOP ACOUSTIC STIMULATION NEUROTECHNOLOGY IMPROVES HEART RATE VARIABILITY AND BAROREFLEX SENSITIVITY: RESULTS OF A PLACEBO-CONTROLLED CLINICAL TRIAL

Abstract

Introduction: Sympathetic hyperarousal contributes to insomnia, and there is a need for effective strategies for improving autonomic regulation. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) is a closed-loop, allostatic, acoustic stimulation neurotechnology that uses software-guided algorithmic analysis to translate selected brain frequencies into audible tones, to support real time self-optimization of brain activity. Methods: In this IRB-approved study of HIRREM for insomnia, 694 subjects were screened, and 122 with Insomnia Severity Index (ISI) scores of ≥15 were enrolled and randomized to receive either ten, 90 minute sessions of HIRREM plus current care (HCC), or placebo (random audible tones) plus current care (PCC), over 1-2 weeks. Tenminute recordings of blood pressure and heart rate were obtained at enrollment (V1), 1-2 weeks (V2), and 2 (V3, primary outcome) and 4 months (V4) post-intervention to evaluate changes in autonomic cardiovascular regulation as measured by baroreflex sensitivity (BRS) and heart rate variability (HRV). Results: 101 completed intervention (52 HIRREM, 49 placebo; mean age 53.3 +/- 14.6, 69 women). Preliminary analysis (n=97) shows significant increases at V3 for multiple BRS and HRV measures in the HCC group, with durability to V4, including increases in HF alpha (ms/mmHg, V1=18.2, V3=25.3, p=0.001, V4=24.4, p=0.006), BRS Sequence All (ms/mmHg, V1=12.9, V3=20.6, p<0.001, V4=17.98, p=0.003), rMSSD (ms, V1=28.6, V3=54.5, p<0.001, V4=52.2, p<0.001), and HF absolute power (ms2, V1=393, V3=1241, p=0.02, V4=928, p=0.03). There were no significant increases in these measures in the PCC group at V3 or V4. Conclusion: In individuals with insomnia, use of HIRREM was associated with significant improvements in multiple BRS and HRV measures, suggesting durable increase in parasympathetic influence. These findings may have special significance in the context of recent studies showing autonomic dysregulation in insomnia and other sleep disorders.