Overcoming the Impedance Range Limitations of Portable Bioelectrical Impedance Spectroscopy Clinical Devices.

Several portable commercial bioimpedance spectroscopy (BIS) devices are used in clinical research, but are limited by their reduced impedance measuring range to less demanding four-electrode configuration measurements. Some of these devices provide raw bioimpedance data for research purposes. The SFB7 device from ImpediMed® is a typical portable clinical device which perform 256 measurement points from 3 kHz to 1 MHz, providing for each point the resistance R and the reactance X. Its main drawback is its impedance range, limited to only 1100 Ω, making it less suitable for more demanding, higher impedance, two-electrode measurements which are potentially of great clinical interest. Some benchtop reference devices have larger frequency and impedance ranges than the SFB7 but are not portable and are not designed specifically for BIS measurement on humans.This article proposes a method to overcome the impedance range limitation of the SFB7 by connecting in parallel to the investigated bioimpedance a fixed and known impedance, whose value (and hence that of the total measured impedance) is within the device's range. The investigated impedance is then calculated by eliminating the contribution of the known impedance via a post processing of the data.This concept has been successfully tested on a physical model, and an in vivo example has validated the practicality of performing demanding two-electrode measurements on individuals using a SFB7, with relative errors of R and X inferior to 2.5% and 7% respectively.Clinical Relevance- Using the proposed setup and after post processing of the data, the SFB7 BIS device can now be used to perform demanding two-electrode measurements, hitherto impossible, enabling a range of novel clinical, high-impedance studies, for example for localized skin characterization.

Recording of bruxism events in sleeping humans at home with a smart instrumented splint.

Objective: The aim of this paper is to report quantitative and qualitative characteristics of bruxism events recorded in sleeping humans with a new smart ambulatory system specifically designed to measure dental clenching and grinding forces. The device is wireless and rechargeable, which enables its use over extended periods.Methods: Thirty recordings were obtained from volunteer subjects who wore the device at home during 10 consecutive nights (Clinicaltrials.gov N° NCT03363204).Results: The recordings showed that the system was able to successfully monitor bruxism during 10 consecutive nights, allowing a quantitative (number, duration, intensity, distribution during the night), as well as a qualitative characterization of the bruxism events (clenching vs. grinding).Discussion: This system could offer new perspectives in the field of bruxism, either as a research tool for clinical studies or as a medical device for the ambulatory home-based monitoring of bruxism.

Pulse wave velocity measurement along the ulnar artery in the wrist region using a high frequency ultrasonic array.

A pulse wave velocity (PWV) measurement method performed above a small blood vessel using an ultrasonic probe is studied and reported in this paper. These experimentations are carried out using a high-frequency probe (14-22 MHz), allowing a high level of resolution compatible with the vessel dimensions, combined with an open research ultrasound scanner. High frame-rate (HFR) imaging (10 000 frames per second) is used for a precise PWV estimation. The measurements are performed in-vivo on a healthy volunteer. The probe is placed above the ulnar artery on the wrist in order to make longitudinal scans. In addition to conventional duplex ultrasound evaluation, the measurement of the PWV using this method at this location could strengthen the detection and diagnosis of cardiovascular diseases (CVDs), in particular for arm artery diseases (AADs). Moreover, these experimentations are also carried out within the scope of a demonstration for a potential miniaturized and wearable device (i.e., a probe with fewer elements, typically less than 32, and its associated electronics). The study has shown results coherent with expected PWV and also promising complementary results such as intima-media thickness (IMT) with spatiotemporal resolution on the order of 6.2 µm and 0.1 ms.

Optical flow sensor as a reference for reduction of motion artefacts in photoplethysmographic measurements.

Methods commonly used for reduction of motion artefacts in photoplethysmography employ accelerometry as a reference for adaptive filtering and signal processing. In this paper, we propose the use of an optical flow sensor to measure the relative displacement between a photoplethysmographic sensor and the measurement site. In order to evaluate the performances of this novel method, a wrist-worn device that enables simultaneous acquisition of physiological information and relative motion has been developed. The optical flow sensor provides a two-dimensional information source correlated with artefacts contained in the cardiac frequency band. Preliminary results show a clear correlation between motion recorded by the sensor and artefacts contained in the photoplethysmographic signal. In association with adaptive filtering, the proposed technique shows efficient reduction of motion artefacts during physical activity.

Evaluation of a real-time low-power cardiorespiratory sensor for the IoT.

A wide variety of sensors have been developed in the biomedical engineering community for telemedicine and personalized healthcare applications. However, they usually focus on sensor connectivity and embedded signal processing, at the expense of the sensing part. This observation lead to the development and exhaustive evaluation of a new ECGbased cardiorespiratory IoT sensor. In order to improve the robustness of our IoT-based sensor, we discuss in detail the influence of electrodes placement and nature. Performance assessment of our sensor resulted in a best-case sensitivity of 99.95% and a precision of 99.89% for an abdominal positioning of wet electrodes, while a sensitivity of 99.47% and a precision of 99.31% were observed using a commercialgrade dry electrodes belt. Consequently, we prove that our sensor is fit for the comfortable medical-grade monitoring of the cardiorespiratory activity in order to provide insights of patients health in a telemedicine context.

Ambulatory sensor for circumference monitoring of lower limbs.

The continuous monitoring of edema in the lower limbs of the human body is presently not possible as suitable devices are not available. This paper presents the characterization and the testing of a novel ambulatory device dedicated to the monitoring of circumference variations in the lower limb. The sensor, based on an inductive loop integrated into a textile band, is connected to a miniaturized electronic system which wirelessly sends the calculated perimeter value of the leg to a smart mobile device. In-vitro tests have demonstrated that the device enables the measurement of perimeters ranging from 25 cm to 33 cm with an accuracy of 0.3 cm. This result was obtained using a circular loop, which assumes that the shape of the leg remains circular at the location where the loop is positioned. To investigate the influence of the loop shape on the sensor response, three physical models of different shapes (circular, elliptic and triangular) were tested. It was found that self-inductance values of the loop can be predicted in an acceptable way using a theoretical model for the three different shapes. Experimental tests showed that the error in the perimeter value is around 5% of the full scale when changing the geometry from circular to elliptic but can reach 11 % from circular to triangular. The application interface developed for a smartphone is presented, which will enable the ambulatory monitoring of leg edemic swelling during daily activity and facilitate its assessment by the clinician.

Analysis of the pen pressure and grip force signal during basic drawing tasks: The timing and speed changes impact drawing characteristics.

Writing is a complex fine and trained motor skill, involving complex biomechanical and cognitive processes. In this paper, we propose the study of writing kinetics using three angles: the pen-tip normal force, the total grip force signal and eventually writing quality assessment. In order to collect writing kinetics data, we designed a sensor collecting these characteristics simultaneously. Ten healthy right-handed adults were recruited and were asked to perform four tasks: first, they were instructed to draw circles at a speed they considered comfortable; they then were instructed to draw circles at a speed they regarded as fast; afterwards, they repeated the comfortable task compelled to follow the rhythm of a metronome; and eventually they performed the fast task under the same timing constraints. Statistical differences between the tasks were computed, and while pen-tip normal force and total grip force signal were not impacted by the changes introduced in each task, writing quality features were affected by both the speed changes and timing constraint changes. This verifies the already-studied speed-accuracy trade-off and suggest the existence of a timing constraints-accuracy trade-off.

Design and development of an impedimetric-based system for the remote monitoring of home-based dialysis patients.

A key clinical challenge is to determine the desired 'dry weight' of a patient in order to terminate the dialysis procedure at the optimal moment and thus avoid the effects of over- and under-hydration. It has been found that the effects of haemodialysis on patients can be conveniently monitored using whole-body bioimpedance measurements. The identified need of assessing the hydrational status of patients undergoing haemodialysis at home gave rise to the present Dialydom (DIALYse à DOMicile) project. The aim of the project is to develop a convenient miniaturised impedance monitoring device for localised measurements (on the calf) in order to estimate an impedimetric hydrational index of the home-based patient, and to transmit this and other parameters to a remote clinical site. Many challenges must be overcome to develop a robust and valid home-based device. Some of these are presented in the paper.

Local effect of compression stockings on skin microcirculatory activity through the measurement of skin effective thermal conductivity.

This paper presents a preliminary study to demonstrate the instantaneous local effect of compression stocking (Class 2) on skin microcirculatory activity. The measurement needs to be carefully performed as the sensor is placed under the garment. To assess the local effect of compression stockings, we use the ambulatory device Hematron located on the calf under the garment. Skin microcirculatory activity is assessed through the skin's effective thermal conductivity measurement. A specific housing for the sensor has been designed to avoid excessive pressure induced by the sensor when squeezed by stockings. The experiment, conducted on ten healthy subjects, comprised two stages: without and with compression stockings. Skin effective thermal conductivity was recorded at three successive positions (supine, sitting and standing). Significant improvement in skin microcirculatory activity was recorded by the Hematron device for the three positions. We have also demonstrated that Hematron sensor can be used under compression stockings.

The challenges facing wearable sensor systems.

It has been pointed out that, in spite of significant national and international funding programmes, there is a dearth of successfully commercialised wearable monitoring systems. Although problems such as financial reimbursement, device interoperability and the present lack of the required connected healthcare infrastructure are major hurdles to the provision of remote clinical monitoring of home-based patients, the "Mount Everest" of monitoring applications, why are wearable systems not already commercialised and used in less demanding applications? The numerous wearable systems which appear on the Web and even in the literature are, for the most part, basic prototypes unsuited to the demands of real-life applications. SMEs which do seek to commercialise clinically promising systems are unfortunately faced with many challenges and few as yet have survived long enough to successfully commercialise their innovations.

Objective evaluation of stress with the blind by the monitoring of autonomic nervous system activity.

Accessibility for the blind in an urban space must be studied under real conditions in their daily environment. A new approach for evaluating the impact of environmental conditions on blind pedestrians is the objective measure of stress by the monitoring of the autonomic nervous system (ANS) activity. Original techniques of data analysis and spatial representation are proposed for the detection of the ANS activity through the assessment of the electrodermal activity. Skin resistance was recorded with an EmoSense system on 10 blind subjects who followed a charted course independently. The course was 1065 meters long and consisted of various environmental conditions in an urban space. The spatial frequency of the non-specific skin resistance responses was used to provide a more relevant representation of geographic hotspots. Results of statistical analysis based on this new parameter are discussed to conclude on phenomena causing mental stress with the blind moving in an urban space.

Introducing knowledge of wearing compression stockings on the skin blood flow by using microHematron device.

The aim of this preliminary study was to review the actual state of knowledge concerning the mechanisms underlying compression medical stockings action on the skin blood flow (SBF) in capillaries. SBF was assessed by measuring the thermal conductivity of living-tissues using microHematron ambulatory device. The investigation was performed for different postures using three standard French classes (10-15 mmHg, 15-20 mmHg and 20-36 mmHg) of Medical compression stockings (MCS) on six healthy subjects without chronic venous insufficiency. The experiment was divided into four stages (supine, sitting, standing and walking) and was repeated for each class of compression stockings and without MCS. The results showed a significant improvement of SBF depending on the class of MCS used. Best results were obtained for the Class III, which exerts to the highest level of pressure exerted around the ankle. Due to the low number of subjects, which therefore reduces the statistical relevance of results, a non-significant difference in SBF due to the subject's posture was observed. Nonetheless, a positive action by all the classes of MCS on SBF was measured for the supine position. This is a very important result; with patients with chronic venous insufficiency have often some mobility reduction, MCS may enhance their microcirculation even at rest.

Design and validation of an ambulatory system for the measurement of the microcirculation in the capillaries: microHematron device.

The non-invasive Hematron sensor is an active sensor used in studying skin blood flow (SBF) by measuring thermal conductivity of living tissues. Up to now, the Hematron device was composed of the Hematron probe and a heavy analog conditioning electronics. This paper presents the design, realization and validation of an ambulatory device (microHematron) associated with the original Hematron probe. The electronic architecture is based on a Programmable System on Chip (PSoC), which contributes in reducing the number of discrete components, and consequently, the electronic conditioning circuit of Hematron. The microHematron device can be worn on the wrist of the patient thanks to its size (4x3x1cm3) compared to the non-ambulatory conditioning electronics sized 20x30x20cm3. In addition, data can be stored in a microSD card or transmitted using a ZigBee module. The validation of the microHematron device was performed using the analog conditioning electronics as a reference. Experiments were performed first on a physical model reproducing microcirculation in order to characterize the linearity of the thermal conductivity as a function of water flow. Then, two experiments were hold in-vivo conditions highlighting the performances of this new device. In a first experiment, effects of mental calculation on effective tissue perfusion were measured and in a second one, effects of an anti-cellulite cream on micro-vascularisation and skin temperature were studied.

A wearable, low-power, health-monitoring instrumentation based on a Programmable System-on-Chip.

Improvement in quality and efficiency of health and medicine, at home and in hospital, has become of paramount importance. The solution of this problem would require the continuous monitoring of several key patient parameters, including the assessment of autonomic nervous system (ANS) activity using non-invasive sensors, providing information for emotional, sensorial, cognitive and physiological analysis of the patient. Recent advances in embedded systems, microelectronics, sensors and wireless networking enable the design of wearable systems capable of such advanced health monitoring. The subject of this article is an ambulatory system comprising a small wrist device connected to several sensors for the detection of the autonomic nervous system activity. It affords monitoring of skin resistance, skin temperature and heart activity. It is also capable of recording the data on a removable media or sending it to computer via a wireless communication. The wrist device is based on a Programmable System-on-Chip (PSoC) from Cypress: PSoCs are mixed-signal arrays, with dynamic, configurable digital and analogical blocks and an 8-bit Microcontroller unit (MCU) core on a single chip. In this paper we present first of all the hardware and software architecture of the device, and then results obtained from initial experiments.

Evaluation of the autonomic nervous system for fall detection.

Studies show that the proportion of elderly will reach 30% of the total population by 2050 in developed countries, such as France. The elderly live generally alone, thus many health problems related to age are under reported. Falling is one of these problems and several devices have been developed recently, based on accelerometers, in order to detect it and alert carers. In order to improve the detection success of these devices, we propose quantifying autonomic nervous system activity (ANS) using a wearable ambulatory device developed for this purpose. We studied the A.N.S's response on 7 adult subjects during simulated falls and standing-lying transitions. We implemented a classification method using the Support Vector Machine in order to classify these two situations using measured heart rate variability and electrodermal response. Good results (sensibility = 70.37%, specificity = 80%, positive predictor = 73.8%) were obtained using a Polynomial kernel (p = 5) for the support vector machine implementation.

An integrated device to evaluate a driver's functional state.

In the field of cognitive ergonomics, research on car drivers requires multimodal in-vehicle systems for recording not only driving-related behavior, but also contextual information from their surroundings. In addition, reliable information concerning a driver's functional state should be obtained. In this article, we describe an integrated device simultaneously recording specific physiological data, video recordings of the driver and environment, parameters from the vehicle, and contextual data. Physiological signals from the autonomic nervous system provide objective and quantitative information on the driver's alertness and his/her ability to process specific driving-related stimuli or other nonspecific information. Consequently, recorded physiological responses can be related to individual driving events. Electrodermal and cardiac activities are sensitive to time-dependent variations in arousal level and to certain external stimuli, so there is great interest in studying drivers' behavior via measured physiological signals that have been established as suitable behavioral indicators. The present integrated device is capable of processing the relevant indices from raw measured data in real time.

Cerebral temperature varies across circadian phases in humans.

The 24-hour rhythm of core body temperature (CBT) is commonly used in humans as a tool to assess the oscillation of the central endogenous circadian pacemaker. The invasive nature of the rectal sensor used to collect CBT makes it difficult to use in ambulatory conditions. Here we validate the use of a newly developed brain temperature (BT) sensor against that of a standard rectal temperature sensor using a 72-hour ultra-rapid sleep-wake (URSW) cycle procedure. A significant circadian variation of both body temperature recordings was observed from which a phase and amplitude was reliably determined. These results indicate that BT can be refined as a non-invasive alternative to CBT measurements in the evaluation of circadian phase in field conditions.

Characterisation of a multi-frequency wound impedance mapping instrument.

A new instrument has been developed enabling clinicians to map and study the healing process of a wound. Early assessment of the instrument demonstrated promising results both during bench testing as well as during initial in vivo measurements on a skin abrasion. Clear differences between healthy and wounded tissue were demonstrated and a pattern was observed, potentially indicative of the healing process for this particular wound.

3D ultrasound elastography for early detection of lesions. evaluation on a pressure ulcer mimicking phantom.

A pressure ulcer is a damaged tissue area induced by an unrelieved pressure compressing the tissue during a prolonged period of immobility. The lack of information and studies on the development of this pathology makes its prevention difficult. However, it is both acknowledged that lesions initiate in the deep muscular tissues before they expand to the skin, and that lesions are harder than healthy tissues. Elastography is therefore an interesting tool for an early detection of the pathology. A 3D strain estimation algorithm is presented and evaluated on a PVA-cryogel phantom, mimicking a pressure ulcer at an early stage.

Infrared imaging analysis for thermal comfort assessment.

Skin temperature is a relevant and effective indicator for objective evaluation of human sensations and thermal states according to the surrounding thermal stresses. Managed by skin blood flow, sympathetic nervous system (constriction and sweating), subcutaneous thermal structure and facial vein patterns, facial coetaneous temperature variability can give information non-invasively on many physiological functions. These informations are deduced from thermal images obtained by far infrared imaging (7 - 14 microm). The work presented here deals with facial thermographic image analysis. Thermal regions of interest are extracted, such as left and right front, left and right cheek, left and right periobital region. Each region is analyzed by the FFT power spectrum calculation regarding to specific spectral band.