Studies and Papers written on the ANS Medical DeviceTechnology used in our Platform

BIOIMPEDANCE IN THE MONITORING OF EFFECTS OF SELECTIVE SEROTONIN REUPTAKE INHIBITOR TREATMENT

Premise

The use of the Electro Interstitial Scan (EIS) to perform bioimpedance measurements to follow up the efficacy of selective serotonin reuptake inhibitor (SSPI) treatment in subjects diagnosed to have a major depressive disorder.

Result

EIS electrical conductivity measurement in the forehead pathway showed high specificity and sensitivity at day 45 for distinguishing between responders and non-responders to SSRI therapy. The specificity and sensitivity decreased at day 60. The EIS electrical dispersion a parameter in the forehead pathway has a high specificity and sensitivity at day 45 when comparing responders and nonresponders. and the specificity and sensitivity increase at day 60.

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RM-3A RISK ASSESSMENT FOR DIABETES

Premise

To determine the validity of ANS function indicators to screen for type 2 diabetes mellitus, as measured by the TM-Oxi and RM-3A system.

Result

The TM-Oxi and RM-3A system shows promise as valid. convenient. and non-invasive screening method for type 2 diabetes mellitus. The ANS function and CMR indicators measured by this system may be useful in guiding diabetes and cardiovascular health screening, treatment. and monitoring.

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RM-3A ANALYSIS OF PHOTO PLETHYSMOGRAPHY TO EVALUATE AN INDEPENDENT CARDIOVASCULAR RISK FACTOR

Premise

The evaluation of homeostatic markers correlated to autonomic nervous and endothelial functions in a population of coronary artery disease (CAD) patients versus a control group to determine whether an independent cardiovascular risk score based on these markers can be used alongside known conventional cardiovascular risk markers to strengthen the understanding of a patient's vascular state.

Result

The spectral analysis of the photoplethysmography method is noninvasive. fast, operator-independent, and cost-effective, as only an oximeter, and a galvanic skin response device, are required in order to assess in single testing the autonomic nervous system and endothelial function. The spectral analysis techniques used on the photo plethysmogram, as outlined in this study, could be useful when used alongside conventional known cardiovascular disease risk markers.

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RM-3A ANALYSIS OF NEUROPATHY USING SUDOMOTOR TEST IN TYPE 2 DIABETES

Premise

To evaluate the efficacy of a Sudomotor testing device to detect peripheral distal neuropathy (PDN) and cardiac autonomic neuropathy (CAN) in patients with type 2 diabetes.

Result

The RM-3A device will be useful to assess the susceptibility of type 2 diabetes patients in developing PDN complications.

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RM-3A COMPARISON OF ACCURACY OF ES-BC, EIS-GS, AND ES OXI ON BODY COMPOSITION, AUTONOMIC NERVOUS SYSTEM ACTIVITY, AND CARDIAC OUTPUT TO STANDARDIZED ASSESSMENTS

Premise

To compare each to a standardized assessment: ES-BC to dual-energy X-ray absorptiometry (DXA). EIS-GS to heart rate variability, and ES Oxi to BioZ Dx Diagnostic System (Baozi Dx; SonoSite Inc, Bothell, WA).

Result

ES-BC and ES Oxi accurately assessed body composition and cardiac output compared to standardized instruments, whereas EIS-GS showed a marginal predictive ability for autonomic nervous system activity. The ESC software managing the three devices would be useful to help detect complications related to metabolic syndrome, diabetes, and cardiovascular disease and to noninvasively and rapidly manage treatment follow-up.

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RM-3A ES COMPLEX ANALYSIS OF HOMA2-IR AND HBA1C WITH ALGORITHMS DERIVED FROM BIO IMPEDANCE AND SPECTROPHOTOMETRIC DEVICES.

Premise

Homeostasis model assessment of insulin resistance (HOMA2-112) and HbAlc, markers of metabolic syndrome and glycemic control, were compared with Electro Sensor (ES) Complex software algorithms. ES complex software integrates data from Electro Sensor Oxi (ESO; spectrophotometry) and Electro Sensor-Body Composition (ES-BC; bio-impedance).

Result

This study in subjects with obesity suggests that ES complex algorithms will be useful in large-scale screening studies to predict insulin resistance, metabolic syndrome, and HbAlc >6.5%.

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EFFECTS OF CARDIAC AUTONOMIC NEUROPATHY ON MORTALITY

Premise

To study the effects of cardiac autonomic dysfunction on mortality risk in the action to control cardiovascular risk in diabetes (accord) trial.

Result

Whereas CAN was associated with increased mortality in this high-risk type 2 diabetes cohort, these analyses indicate that participants with CAN at baseline had similar mortality outcomes from intensive compared with standard glycemia treatment in the ACCORD cohort.

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INSULIN RESISTANCE DETECTION

Premise

To detect Insulin Resistance using spectral analysis of arterial plethysmography versus hyperinsulinemic-euglycemic clamp

Result

PTG TP parameter has the best AUC (0.95) comparing with the other existing available tests to detect the M value < 4.5 of the HE clamp. Therefore, PTG TP provided by the ES Complex system represents a novel parameter of screening and follow-ups for insulin resistance in a large-scale population. This parameter is an independent factor of risk for T2DM and cardiovascular diseases.

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COMPARING THE ACCURACY OF ES-BC, EIS-GS, AND ES OXI ON BODY COMPOSITION, AUTONOMIC NERVOUS SYSTEM ACTIVITY, AND CARDIAC OUTPUT TO STANDARDIZED ASSESSMENTS

Premise

To compare each to a standardized assessment: ES-BC to dual-energy X-ray absorptiometry (DXA), ElS-GS to heart rate variability, and ES Oxi to BioZ Dx Diagnostic System (BioZ Dx; SonoSite Inc, Bothell, WA).

Result

ES-BC and ES Oxi accurately assessed body composition and cardiac output compared to standardized instruments, whereas EIS-CS showed a marginal predictive ability for autonomic nervous system activity.

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NEW MARKER USING BIOIMPEDANCE TECHNOLOGY IN SCREENING FOR ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD) IN CHILDREN AS AN ADJUNCT TO CONVENTIONAL DIAGNOSTIC METHODS

Premise

To diagnose attention-deficit/hyperactivity disorder (ADHD) in children using an easy-to-use, fast, and cost-effective tool to avoid misdiagnosis that may lead to the possibility of errors in treatment, with treatment monitoring for numerous possible side effects that could be especially damaging in view of the age of the population.

Result

The EIS marker related to the conductivity measurements of the forehead pathway has a high specificity and high sensitivity and the use of this could provide practitioners with a non-invasive, low-cost system that is easy to use in the office and could offer an adjunct to the conventional diagnosis of ADHD children.

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AGE MATCHED ATTENUATION OF BOTH AUTONOMIC BRANCHES IN CHRONIC DISEASE: Ill. CORONARY ARTERY DISEASE

Premise

To study the relationship between the resting Parasympathetic nervous system and the Sympathetic nervous system (P & S) activity and the duration of Coronary Artery Disease (CAD).

Result

Excess S activity relative to P activity at rest (high sympathovagal balance [SB=S/P]) is associated with CAD and heart disease. Even with cardiac medication on aboard, and their BPs controlled (average BP for the cohort was less than 153/89), the CAD presented at ages 45 and 55 with advanced autonomic dysfunction, with P and §S levels continuing to decline until age 75, on average.

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DIABETIC NEUROPATHIES

Premise

A statement by the American Diabetic Association based on recent technical reviews and detailed discussions on the diagnosis and symptomatic treatment of Diabetic Neuropathies.

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THE FRAMINGHAM HEART STUDY

Premise

To study the impact of reduced Heart Rate Variability on risk for cardiac events in a large community-based population, but reduced heart rate variability predicted increased risk for subsequent cardiac events.

Result

Out of the 5698 subjects tested, only 2501 men and women were found to be free of clinically apparent heart disease. The mean age was found to be 52 years for men and 54 years for women. Women had higher HDL cholesterol levels, a lower ratio of total to HDL cholesterol, lower diastolic blood pressure, and higher mean heart rate than men.

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STUDY OF THE SECOND DERIVATIVE OF THE FINGER PHOTOPLETHYSMOGRAM

Premise

To elucidate on the independent determinants of the Second Derivative of the Finger Photoplethysmogram (SDPTG) among various Cardiovascular risk factors in middle-aged men.

Result

The results indicate that several risk factors for CVD, such as age. hypertension. dyslipidemia. IFG/DM. a lack of regular exercise, and excessive drinking (6 to 7 days per week). were significantly associated with the SDPTG indices. The study also showed that the SDPTG indices were robustly related to age.

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ENDOTHELIAL DYSFUNCTION IN ATHEROSCLEROSIS

Premise

To elucidate on the role of Endothelial Dysfunction in Atherosclerosis

Result

Endothelium and its product nitric oxide (NO) are key regulators of vascular health. Reduced bioavailability of NO is involved in the initiation, progression, and complications of atherosclerosis. The deficiency of nitric oxide in coronary or peripheral arteries is predictive of future cardiovascular events.

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DIABETES, GLUCOSE, INSULIN, AND HEART RATE VARIABILITY - The Atherosclerosis Risk in Communities (ARIC) study

Premise

To describe the progression of autonomic impairment among individuals with diabetes and pre-diabetic metabolic impairments.

Result

Cardiac autonomic impairment appears to be present at early stages of diabetic metabolic impairment, and progressive worsening of autonomic cardiac function over 9 years was observed in diabetic subjects.

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VITAMIN D STATUS, AUTONOMIC NERVOUS SYSTEM ACTIVITY, AND CARDIOMETABOLIC RISK

Premise

To explore the association between vitamin D status (serum 25-hydroxyvitamin D (25(OH)D)) and a cardiometabolic risk score (CMRS) derived from markers of cardiac autonomic nervous system activity. vascular dynamics, and body composition. using innovative non-invasive technology.

Result

CVD risk and vitamin D status and the benefit of vitamin D supplementation on cardiovascular health are established. The observations that vitamin D deficiency, cardiac ANS, and endothelial dysfunction are independently linked to CVD-related outcomes suggest a potential relationship between vitamin D deficiency and cardiovascular risk in diseased and healthy humans. Vitamin D affects multiple cellular signaling pathways via genomic and nongenomic actions that have the potential to affect cardiovascular health.

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ASSESSMENT OF VASCULAR AGING AND ATHEROSCLEROSIS IN HYPERTENSIVE SUBJECTS: Second Derivative of Photoplethysmogram Versus Pulse Wave Velocity

Premise

To compare SDPTG and PWV concerning the influencing factors of vascular compliance, including age and atherosclerosis, in a large hypertensive population.

Result

In a population of treated or untreated subjects with essential hypertension, aortic PWV was strongly related to age, blood pressure, and atherosclerosis, whereas the parameters of PTG or SDPTG were only strongly related to age. Thus, the PWV seems to be a= better marker of the presence of atherosclerosis, both in young and elderly patients,thantheSDPTGACI, which is related to AA only in older patients.

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DETERMINATION OF AGE-RELATED INCREASES IN LARGE ARTERY STIFFNESS BY DIGITAL PULSE CONTOUR ANALYSIS

Premise

To examine the timing of discrete components of the DVP to formulate an index of the contour of the DVP expected to relate to large artery stiffness (SIDVP), and also examine the relationship of SIDVP to age in asymptomatic subjects on no drug treatment, and compared SIDVP with values of PWV measured over the carotid-to-femoral region (PWVcf).

Result

An index of vascular stiffness, SIDVP (derived from the DVP) is correlated with PWVcf, varies with age and blood pressure in a similar manner to PWVcf. and is influenced by vasoactive drugs to a similar extent as is PWVcf. The method for acquiring SIDVP is simple, inexpensive, rapid, and requires no special training. It is suitable for use in large-scale trials.

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DIABETES: SWEAT RESPONSE AND HEART RATE VARIABILITY DURING ELECTRICAL STIMULATION IN CONTROLS AND PEOPLE WITH DIABETES

Premise

To examine whether electrical stimulation might be used as a predictive tool for assessing autonomic nervous system dysfunction in people with diabetes.

Result

People with diabetes have poor circulation due to vascular endothelial cell impairment. As a consequence of either reduced production or decreased sensitivity to NO, blood vessels remain constricted and show diminished ability to vasodilate. The HRV is lower in people with diabetes showing a very small variation in heart rate that is nearly flat in appearance.

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THE RELATIONSHIP BETWEEN VASCULAR FUNCTION AND THE AUTONOMIC NERVOUS SYSTEM

Premise

To summarize findings concerning the interrelationship between vascular function and the autonomic nervous system from both experimental and clinical studies. The clarification of this interrelationship is aimed towards providing more comprehensive risk stratification and a new effective therapeutic strategy against atherosclerosis.

Result

Although there is much evidence linking the ANS and endothelium in healthy and diseased states, this area is still largely unexplored both under physiological and pathological conditions. The clarification of this interrelationship between the ANS and endothelium may provide more comprehensive risk stratification and a new effective therapeutic strategy against atherosclerosis.

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ASSESSMENT OF INSULIN SENSITIVITY BY THE HYPERINSULINEMICEUGLYCEMIC CLAMP: COMPARISON WITH THE SPECTRAL ANALYSIS OF PHOTOPLETHYSMOGRAPHY

Premise

To compare the spectral analysis of photoplethysmography (PTG) with insulin resistance measured by the hyperinsulinemic-euglycemic clamp (HEC) technique.

Result

With 45.8% of diabetic individuals going undiagnosed (Beagley, Guariguata, Weil, & Motala, 2014), this high prevalence of undiagnosed diabetics could be explained, among other reasons, by the slow progression of T2DM. The slow onset and/or asymptomatic feature of DM leads individuals to perform diagnostic tests much later, when micro or macrovascular complications, such as retinopathy, nephropathy, and coronary artery disease, have appeared (Thompson et al.,1996).

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DETECTION OF NEUROPATHY USING A SUDOMOTOR TEST IN TYPE 2 DIABETES

Premise

To evaluate the efficacy of a sudomotor testing device to detect peripheral distal neuropathy (PDN) and cardiac autonomic neuropathy (CAN) in patients with type 2 diabetes.

Result

The characteristics of the diabetic groups were similar except for age (mean 66 versus 56 years). However, there was no significant difference in skin conductance measurements in this age range. as shown in the Barontini et al study.2° Therefore, when comparing similar-characteristic diabetic groups. the SudoPath had good sensitivity and acceptable specificity for detecting the PDN, with AUC =0.858. The lower specificity could be explained by the fact that sudomotor dysfunction is the earliest clinically detectable stage of PDN, and therefore the DNS score could be =0 at this stage. It was also found that there was a good correlation between the SMP score and CAN score in all the subjects.

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DIAGNOSIS AND TREATMENT OF PAIN IN SMALL FIBER NEUROPATHY

Premise

To determine a diagnosis for small fiber neuropathy tailored toward identification and treatment of the underlying cause of the neuropathy, when possible, while simultaneously managing symptoms of pain.

Result

Small fiber neuropathy is frequently associated with neuropathic pain. The clinical history and physical examination often are sufficient to make the diagnosis of a small fiber neuropathy. However, additional functional and pathological tests can help to confirm the diagnosis.

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