Abstract
Introduction: Elevated blood pressure is a major modifiable risk for cardiovascular disease. Disturbed central control of cardiovascular regulation due to trauma, stress, anxiety or other causes can lead to rise in blood pressure. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) is a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology using software algorithms to identify specific brain frequencies, and translate them in real time into audible tones, to support self-optimization of brain rhythms. Objective: To evaluate the benefits of adding this nontraditional therapy on BP and symptoms of insomnia in subjects with normal or controlled BP, who are enrolled in an IRB-approved open label feasibility study evaluating HIRREM for diverse neuropsychological disorders. Methods: 236 participants (105 female), mean (SD) age 43.1 (16.5), received 15.7 (4.8) HIRREM sessions over 22.6 (18.2) days, (9.3 (3.4) days with sessions). Brachial BP and insomnia score (ISI) were collected before, and 14.0 (14.0) days after HIRREM completion. Paired t-tests were performed. Results: Before HIRREM, participants were divided in the following groups based on ACC/AHA 2017 BP guidelines, normal n=78, elevated n=36, stage 1 n=50, stage 2 n=57, stage 3 n=14 and crisis n=2. There were no changes in medications throughout the study duration. The use of HIRREM was associated with significant reduction in systolic BP (from 126.1 (19.0) to 123.5 (17.0) mmHg, p=0.007), and diastolic BP (from 75.3 (10.6) to 73.0 (9.0) mmHg, p<0.001), with no change in heart rate. Many participants moved to lower BP stage after V2 with the number of participants within normal BP at V2 increasing from 78 to 88. ISI score decreased from 13.2 (7.2) to 6.7 (5.6), p<0.0001. This change met the clinically meaningful drop in ISI of 6 points or more. Conclusion: These data provide evidence of significant benefits of adding a closed-loop therapy for blood pressure reduction and improving sleep. Further studies are indicated to better define the role of this promising intervention to improve sleep, depression, anxiety, and cardiovascular outcomes.
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