Abstract P602: Reduced Symptoms And Improved Heart Rate Variability Associated With Use Of Closed-Loop Noninvasive Neurotechnology By Migraineurs

Introduction: Migraine is associated with impaired autonomic function, reduced heart rate variability (HRV), increased sympathetic activity, and symptoms of insomnia and depression. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a noninvasive, closed-loop acoustic stimulation neurotechnology that identifies dominant brain frequencies and translates them into audible tones, to support self-optimization of brain rhythms. Objective: We have reported use of HIRREM is associated with improved autonomic balance in a diverse cohort. We explored for effects of HIRREM in a cohort with self-reported migraine enrolled in an IRB-approved open label feasibility study of HIRREM for diverse neuropsychological disorders. Methods: Fifty-two subjects (42 female), mean (SD) age 38.0 (18.6), received 15.9 (3.9) HIRREM sessions (90-120 minutes each) over 9.0 (2.7) days of in-office intervention. Outcomes collected before (V1), and 13.6 (14.4) days after HIRREM completion (V2) included measures of autonomic regulation (baroreflex sensitivity, BRS, and HRV), inventories for insomnia (ISI), depression (CES-D), traumatic stress (PCL-C), and headache (MIDAS). Paired t-tests were performed. Measures of BRS and HRV (n=52) improved from V1 to V2, including HF Alpha (+8.0 ms/mmHg (SE 2.2), p<0.0012), SDNN (+6.1 ms (1.9), p=0.002), and rMSSD ms (+7.6 (2.5), p=0.004). Sympathetic tone to blood vessels and mean arterial pressure were significantly reduced. There were improvements in symptoms at V2, including ISI (n=52): -6.2 (5.7), p<0.0001; CES-D (n=38): -8.0 (9.8), p<0.0001; PCL-C (n=30): -8.2 (11.3); p<0.001; and MIDAS (n=33): -14.9 (41.7), p<0.01). No serious adverse events were reported. Conclusions: This exploratory study shows improved measures of autonomic balance, reduced sympathetic tone, improved sleep and mood. Data suggest that HIRREM is a promising intervention that merits further investigation to mitigate the myriad effects of migraine

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Abstract P485: Use of a Noninvasive, Closed-loop, Allostatic, Neurotechnology Reduced Blood Pressure and Improved Heart Rate Variability in a Pre-hypertensive Cohort

Hypertension ◽

10.1161/hyp.70.suppl_1.p485 ◽

2017 ◽

Vol 70 (suppl_1) ◽

Author(s):

Hossam A Shaltout ◽

Catherine L Tegeler ◽

Charles H Tegeler

Keyword(s):

Blood Pressure ◽

Heart Rate ◽

Heart Rate Variability ◽

Closed Loop ◽

Blood Pressure Reduction ◽

Acoustic Stimulation ◽

Open Label ◽

Neuropsychological Disorders ◽

Effective Interventions ◽

Sequence Method

Background: Prehypertension increases risk for hypertension and cardiovascular disease, but effective interventions have not been defined. Disturbed central control of cardiovascular regulation due to trauma, stress, anxiety or other causes can lead to prehypertension and impaired heart rate variability (HRV). 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 this nontraditional therapy on BP and autonomic function, subjects with untreated systolic BP of 120 to 139 or diastolic BP of 80 to 90 mmHg at baseline, who had enrolled in an IRB-approved open label feasibility study evaluating HIRREM for diverse neuropsychological disorders. Results: 66 participants (40 female), mean (SD) age 43.3 (16.5), received 16 (5.7) HIRREM sessions over 22.4 (19.2) days, (9.5 (4.2) days with sessions). Data were collected before, and 14.4 (16.6) days after HIRREM completion. Use of HIRREM was associated with significantly reduced systolic (from 127.5 (8.0) to 122.9 (14.0) mmHg, p=0.011), and diastolic (from 82.0 (8.0) to 78.0 (9.0) mmHg, p= 0.014) arterial pressure, with no change in heart rate. HRV measured as SDNN increased (from 42.0 (17.0) to 50.0 (28.0) ms, p=0.002). Baroreflex sensitivity measured by sequence method improved (from 13.2 (8.0) to 17.2 (12.0) ms/mmHg, p=0.0001), with a trend for reduced sympathovagal tone measured by LF/HF ratio (from 2.5 (2.2) to 2.0 (1.8), p=0.068). There were no adverse events. Conclusion: These data provide the first report of significant cardiovascular benefits of a closed-loop allostatic therapy for prehypertension. Blood pressure reduction and HRV improvement may prevent progression to more serious cardiovascular symptoms and diseases. Further studies are indicated to investigate the mechanism of the benefits associated with this promising intervention.

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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

SLEEP ◽

10.1093/sleepj/zsx050.362 ◽

2017 ◽

Vol 40 (suppl_1) ◽

pp. A135-A135

Author(s):

HA Shaltout ◽

CL Tegeler ◽

SW Lee ◽

CH Tegeler

Keyword(s):

Clinical Trial ◽

Heart Rate ◽

Heart Rate Variability ◽

Baroreflex Sensitivity ◽

Closed Loop ◽

Acoustic Stimulation ◽

Controlled Clinical Trial

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Abstract P483: Healing a Broken Heart Using a Closed-loop, Allostatic, Neurotechnology: A Case Study in a Patient Suffering From Takotsubo Syndrome

Hypertension ◽

10.1161/hyp.70.suppl_1.p483 ◽

2017 ◽

Vol 70 (suppl_1) ◽

Author(s):

Charles H Tegeler ◽

Catherine L Tegeler ◽

Hossam A Shaltout

Keyword(s):

Heart Rate ◽

Closed Loop ◽

Left Ventricular ◽

Pharmacological Therapy ◽

Stressful Event ◽

Takotsubo Syndrome ◽

Autonomic Balance ◽

Open Label ◽

Software Algorithms ◽

Patient Reported

Background: Stress cardiomyopathy or Takotsubo syndrome (TS) is an acute, reversible disorder of the heart characterized by left ventricular dysfunction, usually triggered by a stressful event. Excessive sympathetic excitation and shift in symapthovagal balance are proposed as mechanisms. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) is a noninvasive, closed-loop, allostatic, neurotechnology using software algorithms to identify specific brain frequencies, translating them in real time into audible tones, to support self-optimization of brain rhythms and improve autonomic balance. Objective: To evaluate benefits of HIRREM on autonomic function and symptom reduction in a 55 year old female enrolled in an IRB-approved open label feasibility study, after TS diagnosis. Results: The participant received 13 HIRREM sessions over 11 days (9 in office days). Data were collected before, and 21 days after HIRREM completion. Baseline brain patterns had prominent right dominance at temporal lobes (sympathetic pattern), which balanced by the end of the sessions. Cardiovascular autonomic balance also shifted away from sympathetic towards parasympathetic. This was seen as reduced LF/HF ratio (from 1.89 to 0.63), increased heart rate variability (rMSSD from 27 to 40.8 ms), and baroreflex sensitivity (from 11.8 to 24.4 ms/mmHg). Blood pressure dropped from 132/90 to 121/88 with no change in heart rate despite discontinuation of her ACE inhibitor medication due to her BP being “too low.” HIRREM use was also associated with clinically meaningful improvements in multiple symptom inventories including insomnia (ISI) from 15 to 6, depression (CES-D) from 16 to 2, anxiety (GAD-7) from 18 to 2, and perceived stress scale (PSS) from 30 to 14. The patient reported resolution of a feeling of heaviness and discomfort in the chest after starting HIRREM sessions. Conclusion: These data provide the first report of potential cardiovascular benefits of a non- pharmacological therapy to patients suffering from broken heart syndrome.

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Abstract P206: Improvement Of Autonomic Function, Sleep, Depression, Anxiety, And Stress In Military Personnel With Traumatic Stress After Use Of A Closed Loop Neurotechnology

Hypertension ◽

10.1161/hyp.78.suppl_1.p206 ◽

2021 ◽

Vol 78 (Suppl_1) ◽

Author(s):

Catherine Tegeler ◽

Lindsay Howard ◽

Kenzie L Brown ◽

Faiza Asif-Fraz ◽

Dawn C Kellar ◽

...

Keyword(s):

Heart Rate ◽

Traumatic Stress ◽

Baroreflex Sensitivity ◽

Primary Outcome ◽

Closed Loop ◽

Autonomic Function ◽

Brain Activity ◽

Acoustic Stimulation ◽

Beneficial Effects ◽

Symptom Scores

Introduction: Symptoms associated with military-related traumatic stress (MTS) include insomnia, depression, anxiety, and impaired autonomic control. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) is a noninvasive, closed-loop acoustic stimulation technology that identifies dominant brain frequencies and translates them in real time into audible tones of variable pitch and timing, to support self-optimization of brain activity. Objective: Evaluate changes in autonomic and symptoms scores after use of HIRREM in subjects enrolled in a pilot study for MTS. Methods: Thirty-two service members or Veterans (1 female), mean (SD) age 40.8 (6.4), with MTS symptoms for 7.3 years (3.9), received 19.2 (1.0) HIRREM sessions over 12 days. Continuous recordings of blood pressure and heart rate, for analysis of baroreflex sensitivity (BRS) and heart rate variability (HRV), were done at V1 and V2. Symptom inventories collected before (Visit 1, V1), immediately after (primary outcome, V2, n = 32), and at 1, 3, and 6 months after completion of HIRREM included traumatic stress (PCL-M), insomnia (ISI), depression (CES-D), and anxiety (GAD-7). Paired t-tests were performed. Results: HIRREM improved BRS measured as HF alpha (10.8 ms/mmHg, 2.5, p<0.001), Sequence Down (7.3 ms/mmHg, 2.1, p<0.001), Sequence Up (7.6 ms/mmHg, 2.4, p=0.001), and Sequence All (7.3 ms/mmHg, 1.8, p<0.001), as well as HRV; SDNN (14.1 ms, 3.6, p=0.005), rMSSD (12.8 ms, 2.6, p<0.05). MAP dropped 2.7 mmHg, 1.2, p<0.05 and SAP dropped 5.9 mmHg, 1.8, p=0.007. Mean symptom scores were reduced at V2; PCL-M [-12.9 (± 9.1), p<0.001], ISI [-6.3 (± 5.0), p<0.001], CES-D [-13.7 (±9.2), p<0.001], and GAD-7 [-6.7. (± 4.7), p<0.001]. Symptom scores improved 1-month post-HIRREM for all measures, and clinically relevant and significant benefits persist at 3 and 6 months. Conclusions: These results suggest improved autonomic cardiovascular regulation and statistically significant reduction in scales associated with the use of HIRREM for symptoms of MTS. Controlled trials could provide important insights regarding both the mechanisms associated with the beneficial effects of HIRREM, and the functional disturbances underlying MTS.

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Relations between combined oral contraceptive therapy and indices of autonomic balance (baroreflex sensitivity and heart rate variability) in young healthy women

Ginekologia Polska ◽

10.17772/gp/1660 ◽

2013 ◽

Vol 84 (11) ◽

Cited By ~ 5

Author(s):

Anna Wilczak ◽

Katarzyna Marciniak ◽

Michał Kłapciński ◽

Agnieszka Rydlewska ◽

Dariusz Danel ◽

...

Keyword(s):

Heart Rate ◽

Heart Rate Variability ◽

Oral Contraceptive ◽

Baroreflex Sensitivity ◽

Autonomic Balance ◽

Combined Oral Contraceptive ◽

Healthy Women ◽

Contraceptive Therapy ◽

Oral Contraceptive Therapy

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Abstract P205: Use Of A Noninvasive, Closed-loop, Allostatic, Neurotechnology Reduced Blood Pressure And Improved Sleep In Heterogeneous Cohort

Hypertension ◽

10.1161/hyp.78.suppl_1.p205 ◽

2021 ◽

Vol 78 (Suppl_1) ◽

Author(s):

Hossam A Shaltout ◽

Catherine Tegeler ◽

Lindsay Howard ◽

Kenzie Brown ◽

Faiza Asif-Fraz ◽

...

Keyword(s):

Blood Pressure ◽

Closed Loop ◽

Blood Pressure Reduction ◽

Acoustic Stimulation ◽

Open Label ◽

Neuropsychological Disorders ◽

Software Algorithms ◽

Stage 1 ◽

Trauma Stress

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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Abstract P627: Improved Autonomic Cardiovascular Regulation and Reduced Symptoms Associated with Use of Closed-loop Noninvasive Neurotechnology by Healthcare Workers

Hypertension ◽

10.1161/hyp.68.suppl_1.p627 ◽

2016 ◽

Vol 68 (suppl_1) ◽

Author(s):

Catherine L Tegeler ◽

Hossam A Shaltout ◽

Lindsay I Howard ◽

Charles H Tegeler

Keyword(s):

Chronic Stress ◽

Healthcare Workers ◽

Closed Loop ◽

Medical Center ◽

Academic Medical Center ◽

Acoustic Stimulation ◽

Cardiovascular Regulation ◽

Global Rating ◽

Open Label ◽

Serious Adverse Events

Introduction: Chronic stress in healthcare workers is associated with insomnia and risk for adverse health outcomes. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a noninvasive, closed-loop acoustic stimulation neurotechnology that identifies dominant brain frequencies and translates them into audible tones, to support auto-calibration and self-optimization of brain rhythms. Objective: We explore use of HIRREM in a cohort of healthcare workers enrolled in an IRB-approved open label feasibility study of HIRREM for diverse neuropsychological disorders. Methods: Twenty five employees (16 female), mean (SD) age 45.8 (13.9), received 14.8 (4.7) HIRREM sessions (90-120 minutes each) over 9.0 (3.6) days of in-office intervention. Data was collected before (V1), and 15.4 (11.7) days after completion (V2). Outcomes included BP and HR recordings for autonomic cardiovascular regulation (baroreflex sensitivity, BRS, and heart rate variability, HRV), with inventories for insomnia (ISI), depression (CES-D), traumatic stress (PCL-C), quality of life (EQ-5D global rating), and drop stick reaction testing (RXT). Paired t-tests were performed. Results: BRS and HRV (n=17) improved from V1 to V2, including Sequence ALL (+2.4 ms/mmHg (SE 2.8), p=0.15), SDNN (+8.9 ms (4.1), p=0.04), and rMSSD ms (+9.2 (4.9), p=0.07). There were significant improvements in symptoms and function at V2; ISI (n=25): -8 (5.3), p<0.0001; CES-D (n=20): -7.3 (13.4), p=0.02; PCL-C (n=19): -12.1 (12.4); p<0.001; EQ-5D (n=16): +10.8 (12.5), p<0.01; RXT (n=18): -4.6 cm (5.5), p<0.01. There were no serious adverse events. Conclusions: This exploratory study shows improved measures of cardiovascular regulation, and reduced insomnia, depression, and stress associated with use of HIRREM in a cohort of employees at an academic medical center. Data suggest that HIRREM is a promising intervention that merits further investigation to mitigate effects of chronic stress and improve wellness.

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The low frequency power of heart rate variability is neither a measure of cardiac sympathetic tone nor of baroreflex sensitivity

AJP Heart and Circulatory Physiology ◽

10.1152/ajpheart.00361.2014 ◽

2014 ◽

Vol 307 (7) ◽

pp. H1005-H1012 ◽

Cited By ~ 44

Author(s):

Davide Martelli ◽

Alessandro Silvani ◽

Robin M. McAllen ◽

Clive N. May ◽

Rohit Ramchandra

Keyword(s):

Heart Failure ◽

Heart Rate ◽

Heart Rate Variability ◽

Baroreflex Sensitivity ◽

Low Frequency ◽

Sympathetic Tone ◽

Cross Correlation Analysis ◽

Healthy Control ◽

Conscious Sheep ◽

Low Frequency Power

The lack of noninvasive approaches to measure cardiac sympathetic nerve activity (CSNA) has driven the development of indirect estimates such as the low-frequency (LF) power of heart rate variability (HRV). Recently, it has been suggested that LF HRV can be used to estimate the baroreflex modulation of heart period (HP) rather than cardiac sympathetic tone. To test this hypothesis, we measured CSNA, HP, blood pressure (BP), and baroreflex sensitivity (BRS) of HP, estimated with the modified Oxford technique, in conscious sheep with pacing-induced heart failure and in healthy control sheep. We found that CSNA was higher and systolic BP and HP were lower in sheep with heart failure than in control sheep. Cross-correlation analysis showed that in each group, the beat-to-beat changes in HP correlated with those in CSNA and in BP, but LF HRV did not correlate significantly with either CSNA or BRS. However, when control sheep and sheep with heart failure were considered together, CSNA correlated negatively with HP and BRS. There was also a negative correlation between CSNA and BRS in control sheep when considered alone. In conclusion, we demonstrate that in conscious sheep, LF HRV is neither a robust index of CSNA nor of BRS and is outperformed by HP and BRS in tracking CSNA. These results do not support the use of LF HRV as a noninvasive estimate of either CSNA or baroreflex function, but they highlight a link between CSNA and BRS.

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