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

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 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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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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Improvements in Heart Rate Variability, Baroreflex Sensitivity, and Sleep After Use of Closed-Loop Allostatic Neurotechnology by a Heterogeneous Cohort

Frontiers in Public Health ◽

10.3389/fpubh.2018.00116 ◽

2018 ◽

Vol 6 ◽

Cited By ~ 4

Author(s):

Hossam A. Shaltout ◽

Sung W. Lee ◽

Catherine L. Tegeler ◽

Joshua R. Hirsch ◽

Sean L. Simpson ◽

...

Keyword(s):

Heart Rate ◽

Heart Rate Variability ◽

Baroreflex Sensitivity ◽

Closed Loop

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Heart rate variability and baroreflex sensitivity are reduced in chronically undernourished, but otherwise healthy, human subjects

Clinical Science ◽

10.1042/cs1040295 ◽

2003 ◽

Vol 104 (3) ◽

pp. 295-302 ◽

Cited By ~ 4

Author(s):

Mario VAZ ◽

A.V. BHARATHI ◽

S. SUCHARITA ◽

D. NAZARETH

Keyword(s):

Heart Rate ◽

Heart Rate Variability ◽

High Frequency ◽

Baroreflex Sensitivity ◽

Human Subjects ◽

Normal Weight ◽

Autonomic Nerve ◽

Total Power ◽

Healthy Human ◽

Frequency Power

Alterations in autonomic nerve activity in subjects in a chronically undernourished state have been proposed, but have been inadequately documented. The present study evaluated heart rate and systolic blood pressure variability in the frequency domain in two underweight groups, one of which was undernourished and recruited from the lower socio-economic strata [underweight, undernourished (UW/UN); n = 15], while the other was from a high class of socio-economic background [underweight, well nourished (UW/WN); n = 17], as well as in normal-weight controls [normal weight, well nourished (NW/WN); n = 27]. Baroreflex sensitivity, which is a determinant of heart rate variability, was also assessed. The data indicate that total power (0–0.4Hz), low-frequency power (0.04–0.15Hz) and high-frequency power (0.15–0.4Hz) of RR interval variability were significantly lower in the UW/UN subjects (P<0.05) than in the NW/WN controls when expressed in absolute units, but not when the low- and high-frequency components were normalized for total power. Baroreflex sensitivity was similarly lower in the UW/UN group (P<0.05). Heart rate variability parameters in the UW/WN group were generally between those of the UW/UN and NW/WN groups, but were not statistically different from either. The mechanisms that contribute to the observed differences between undernourished and normal-weight groups, and the implications of these differences, remain to be elucidated.

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Effect of n-3 fatty acids on heart rate variability and baroreflex sensitivity in middle-aged subjects

American Heart Journal ◽

10.1016/s0002-8703(03)00441-1 ◽

2003 ◽

Vol 146 (2) ◽

pp. 344 ◽

Cited By ~ 30

Author(s):

Anouk Geelen ◽

Peter L Zock ◽

Cees A Swenne ◽

Ingeborg A Brouwer ◽

Evert G Schouten ◽

...

Keyword(s):

Fatty Acids ◽

Heart Rate ◽

Heart Rate Variability ◽

Baroreflex Sensitivity ◽

Middle Aged ◽

Aged Subjects

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Heart Rate Variability And Respiratory Muscle Strength In Patients With Type Ii Diabetes Practicing Pilates: A Randomized Clinical Trial

Current Diabetes Reviews ◽

10.2174/1573399817666210928143752 ◽

2021 ◽

Vol 17 ◽

Author(s):

Samara Sousa Vasconcelos Gouveia ◽

Guilherme Pertinni de Morais Gouveia ◽

Leydnaya Maria Souza ◽

Bruno Cunha da Costa ◽

Gustavo Henrique Melo Sousa ◽

...

Keyword(s):

Clinical Trial ◽

Heart Rate ◽

Heart Rate Variability ◽

Muscle Strength ◽

Normal Distribution ◽

Randomized Clinical Trial ◽

Respiratory Muscle ◽

Control Group ◽

Respiratory Muscle Strength

Purpose: This study aimed to analyze the effect of a Pilates protocol on respiratory muscle strength and heart rate variability (HRV) in patients with type 2 diabetes. Method: A randomized clinical trial (RBR-2gc2qj) was conducted with a type 2 diabetic target population. Patients practiced the Pilates protocol for 8 weeks, with two visits per week. The variables tested were maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and HRV (time and frequency domains). All variables were tested for normal distribution. Using SPSS 21.0, analysis of variance was performed for variables with normal distribution, and the Wilcoxon and Friedman tests were used for variables that did not show a normal distribution, with a 5% significance level. Results: Forty-four participants were included in the study (intervention group: 22; control group: 22; mean age: 61.23 ± 8.49 years), most of whom were female (77.3%), married or in a consensual union (59.1%), had complete literacy (31.8%), and had an average body mass index of 26.96 ± 4.35 kg/m2. There were no significant differences in MIP and MEP before and after the protocol between the intervention and control groups. Regarding HRV, there were significant differences in autonomic modulation, especially between the moments before and during exercise and between the moments during and after exercise; however, it was not possible to determine which system (sympathetic or parasympathetic) is most involved in these changes. Conclusion: The exercise protocol based on the Pilates method did not alter respiratory muscle strength but promoted changes in HRV, especially between the moments before and during exercise and during and after exercise.

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Effects of Respiratory Training on Heart Rate Variability and Baroreflex Sensitivity in Individuals With Chronic Spinal Cord Injury

Archives of Physical Medicine and Rehabilitation ◽

10.1016/j.apmr.2017.06.033 ◽

2018 ◽

Vol 99 (3) ◽

pp. 423-432 ◽

Cited By ~ 8

Author(s):

Bonnie E. Legg Ditterline ◽

Sevda C. Aslan ◽

David C. Randall ◽

Susan J. Harkema ◽

Camilo Castillo ◽

...

Keyword(s):

Spinal Cord ◽

Heart Rate ◽

Spinal Cord Injury ◽

Heart Rate Variability ◽

Baroreflex Sensitivity ◽

Chronic Spinal Cord Injury ◽

Cord Injury ◽

Respiratory Training

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Evaluation of Methods to Minimize Pain in Newborns during Capillary Blood Sampling for Screening: A Randomized Clinical Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph19020870 ◽

2022 ◽

Vol 19 (2) ◽

pp. 870

Author(s):

Magdalena Napiórkowska-Orkisz ◽

Aleksandra Gutysz-Wojnicka ◽

Mariola Tanajewska ◽

Iwona Sadowska-Krawczenko

Keyword(s):

Clinical Trial ◽

Heart Rate ◽

Heart Rate Variability ◽

Pain Management ◽

Pain Relief ◽

Pain Intensity ◽

Randomized Clinical Trial ◽

Capillary Blood ◽

Pain Outcome ◽

Capillary Blood Sampling

Aim: The aim of the study was to assess the severity of pain experienced by a newborn during a heel puncture for screening using the Newborn Pain Scale (NIPS), measure the heart rate and compare the effectiveness of non-pharmacological methods of pain control. Design: Randomized clinical trial. No experimental factors. The test was performed during routine screening. Surroundings: Provincial Specialist Hospital in Olsztyn. Patients/Participants: Pain was assessed in 90 full-term newborns. The newborns were rooming in with their mothers in the hospital. Interventions: Newborns were divided into three groups. Three different methods of pain relief were used: breastfeeding, 20% glucose administered orally and non-nutritional sucking. Main Outcome Measures: The primary pain outcome was measured using the NIPS and the secondary pain outcome measures (heart rate, oxygen saturation) were measured using a pulse oximeter. Results: During capillary blood sampling from the heel, most newborns, n = 56 (62.2%), experienced no pain or mild discomfort, severe pain occurred in n = 23 (25.6%) and moderate pain occurred in n = 11 (12.2%). No significant statistical differences were found between the degree of pain intensity and the intervention used to minimize the pain p = 0.24. Statistically significant relationships were demonstrated between heart rate variability and the degree of pain intensity (p = 0. 01). There were no statistically significant differences between the newborn’s pain intensity and the mother’s opinion on the effectiveness of breastfeeding in minimizing pain. Conclusions: This study did not answer the question of which pain management method used during the heel prick was statistically more effective in reducing pain. However, the results indicate that each of the non-pharmacological interventions (breastfeeding, oral glucose dosing and non-nutritive sucking) applied during heel puncture resulted in effective pain management in most of the newborns enrolled in the study. The relationship between heart rate variability and the severity of pain was confirmed. Mothers of newborns in the breastfeeding group were satisfied with the pain relief methods used in the child and the opportunity to console their newborn during painful procedures in a technologically invasive environment.

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