Stretchable respiration sensors: Advanced designs and multifunctional platforms for wearable physiological monitoring.

Remote patient monitoring should reduce mortality rates, improve care, and reduce costs. We present an overview of the available technologies for the remote monitoring of chronic obstructive pulmonary disease (COPD) patients, together with the most important medical information regarding COPD in a language that is adapted for engineers. Our aim is to bridge the gap between the technical and medical worlds and to facilitate and motivate future research in the field. We also present a justification, motivation, and explanation of how to monitor the most important parameters for COPD patients, together with pointers for the challenges that remain. Additionally, we propose and justify the importance of electrocardiograms (ECGs) and the arterial carbon dioxide partial pressure (PaCO2) as two crucial physiological parameters that have not been used so far to any great extent in the monitoring of COPD patients. We cover four possibilities for the remote monitoring of COPD patients: continuous monitoring during normal daily activities for the prediction and early detection of exacerbations and life-threatening events, monitoring during the home treatment of mild exacerbations, monitoring oxygen therapy applications, and monitoring exercise. We also present and discuss the current approaches to decision support at remote locations and list the normal and pathological values/ranges for all the relevant physiological parameters. The paper concludes with our insights into the future developments and remaining challenges for improvements to continuous remote monitoring systems. Graphical abstract ᅟ.

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Continuous remote monitoring of COPD patients—justification and explanation of the requirements and a survey of the available technologies

Recent advances in wearable sensors and portable electronics for sleep monitoring.

Walking impairments are highly prevalent in persons with multiple sclerosis (PwMS) and are associated with reduced quality of life. Walking is traditionally quantified with various measures, including patient self-reports, clinical rating scales, performance measures, and advanced lab-based movement analysis techniques. Yet, the majority of these measures do not fully characterize walking (i.e., gait quality) nor adequately reflect walking in the real world (i.e., community ambulation) and have limited timescale (only measure walking at a single point in time). We discuss the potential of wearable sensors to provide sensitive, objective, and easy-to-use assessment of community ambulation in PwMS. Wearable technology has the ability to measure all aspects of gait in PwMS yet is under-studied in comparison with other populations (e.g., older adults). Within the studies focusing on PwMS, half that measure pace collected free-living data, while only one study explored gait variability in free-living conditions. No studies explore gait asymmetry or complexity in free-living conditions. Wearable technology has the ability to provide objective, comprehensive, and sensitive measures of gait in PwMS. Future research should investigate this technology’s ability to accurately assess free-living measures of gait quality, specifically gait asymmetry and complexity.

Next Steps in Wearable Technology and Community Ambulation in Multiple Sclerosis.

This chapter introduces the anatomy and physiology of the respiratory system, and the reasons for measuring breathing events, particularly, using wearable sensors. Respiratory monitoring is vital including detection of sleep apnea and measurement of respiratory rate. The automatic detection of breathing patterns is equally important in other respiratory rehabilitation therapies, for example, magnetic resonance exams for respiratory triggered imaging, and synchronized functional electrical stimulation. In this context, the goal of many research groups is to create wearable devices able to monitor breathing activity continuously, under natural physiological conditions in different environments. Therefore, wearable sensors that have been used recently as well as the main signal processing methods for breathing analysis are discussed. The following sensor technologies are presented: acoustic, resistive, inductive, humidity, acceleration, pressure, electromyography, impedance, and infrared. New technologies open the door to future methods of noninvasive breathing analysis using wearable sensors associated with machine learning techniques for pattern detection.

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Breathing Monitoring and Pattern Recognition with Wearable Sensors

Background: Increasingly, drug and device clinical trials are tracking activity levels and other quality of life indices as endpoints for therapeutic efficacy. Trials have traditionally required intermittent subject visits to the clinic that are artificial, activity-intensive, and infrequent, making trend and event detection between visits difficult. Thus, there is an unmet need for wearable sensors that produce clinical quality and medical grade physiological data from subjects in the home. The current study was designed to validate the BioStamp nPoint® system (MC10 Inc., Lexington, MA, USA), a new technology designed to meet this need. Objective: To evaluate the accuracy, performance, and ease of use of an end-to-end system called the BioStamp nPoint. The system consists of an investigator portal for design of trials and data review, conformal, low-profile, wearable biosensors that adhere to the skin, a companion technology for wireless data transfer to a proprietary cloud, and algorithms for analyzing physiological, biometric, and contextual data for clinical research. Methods: A prospective, nonrandomized clinical trial was conducted on 30 healthy adult volunteers over the course of two continuous days and nights. Supervised and unsupervised study activities enabled performance validation in clinical and remote (simulated “at home”) environments. System outputs for heart rate (HR), heart rate variability (HRV) (including root mean square of successive differences [RMSSD] and low frequency/high frequency ratio), activity classification during prescribed activities (lying, sitting, standing, walking, stationary biking, and sleep), step count during walking, posture characterization, and sleep metrics including onset/wake times, sleep duration, and respiration rate (RR) during sleep were evaluated. Outputs were compared to FDA-cleared comparator devices for HR, HRV, and RR and to ground truth investigator observations for activity and posture classifications, step count, and sleep events. Results: Thirty participants (77% male, 23% female; mean age 35.9 ± 10.1 years; mean BMI 28.1 ± 3.6) were enrolled in the study. The BioStamp nPoint system accurately measured HR and HRV (correlations: HR = 0.957, HRV RMSSD = 0.965, HRV ratio = 0.861) when compared to ActiheartTM. The system accurately monitored RR (mean absolute error [MAE] = 1.3 breaths/min) during sleep when compared to a Capnostream35TM end-tidal CO2 monitor. When compared with investigator observations, the system correctly classified activities and posture (agreement = 98.7 and 92.9%, respectively), step count (MAE = 14.7, < 3% of actual steps during a 6-min walk), and sleep events (MAE: sleep onset = 6.8 min, wake = 11.5 min, sleep duration = 13.7 min) with high accuracy. Participants indicated “good” to “excellent” usability (average System Usability Scale score of 81.3) and preferred the BioStamp nPoint system over both the Actiheart (86%) and Capnostream (97%) devices. Conclusions: The present study validated the BioStamp nPoint system’s performance and ease of use compared to FDA-cleared comparator devices in both the clinic and remote (home) environments.

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A Pivotal Study to Validate the Performance of a Novel Wearable Sensor and System for Biometric Monitoring in Clinical and Remote Environments.

Background Although in-lab polysomnography (PSG) remains the gold standard for objective sleep monitoring, the use of at-home sensor systems has gained popularity in recent years. Two categories of monitoring, autonomic and limb movement physiology, are increasingly recognized as critical for sleep disorder phenotyping, yet at-home options remain limited outside of research protocols. The purpose of this study was to validate the BiostampRC® sensor system for respiration, electrocardiography (ECG), and leg electromyography (EMG) against gold standard PSG recordings. Methods We report analysis of cardiac and respiratory data from 15 patients and anterior tibialis (AT) data from 19 patients undergoing clinical PSG for any indication who simultaneously wore BiostampRC® sensors on the chest and the bilateral AT muscles. BiostampRC® is a flexible, adhesive, wireless sensor capable of capturing accelerometry, ECG, and EMG. We compared BiostampRC® data and feature extractions with those obtained from PSG. Results The heart rate extracted from BiostampRC® ECG showed strong agreement with the PSG (cohort root mean square error of 5 beats per minute). We found the thoracic BiostampRC® respiratory waveform, derived from its accelerometer, accurately calculated the respiratory rate (mean average error of 0.26 and root mean square error of 1.84 breaths per minute). The AT EMG signal supported periodic limb movement detection, with area under the curve of the receiver operating characteristic curve equaling 0.88. Upon completion, 88% of subjects indicated willingness to wear BiostampRC® at home on an exit survey. Conclusion The results demonstrate that BiostampRC® is a tolerable and accurate method for capturing respiration, ECG, and AT EMG time series signals during overnight sleep when compared with simultaneous PSG recordings. The signal quality sufficiently supports analytics of clinical relevance. Larger longitudinal in-home studies are required to support the role of BiostampRC® in clinical management of sleep disorders involving the autonomic nervous system and limb movements.

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A novel adhesive biosensor system for detecting respiration, cardiac, and limb movement signals during sleep: validation with polysomnography.

Introduction Real-time digital heart rate (HR) monitoring in sports can provide unique physiological insights into athletic performance. However, most HR monitoring of elite athletes is limited to non-real-time, non-competition settings while utilizing sensors that are cumbersome. The present study was undertaken to test the feasibility of using small, wearable medical-grade sensors, paired with a novel technology system, to capture and process real-time HR data from elite athletes during professional competition. Methods We examined the performance of the BioStamp nPoint® sensor compared to the Polar chest strap HR sensor in 15 Professional Squash Association (PSA) tournament matches in 2019-2020. Fourteen male professional squash players volunteered for the study (age = 23.8 ± 4.9 years; height = 177.9 ± 7.1 cm; weight = 71 ± 7.0 kg), which was approved by the PSA in accordance with their Code of General Conduct and Ethics. Algorithms developed by Sports Data Labs (SDL; Detroit, MI, USA) used proprietary data collection, transmission, and signal processing protocols to produce HR values in real-time during matches. We calculated the mean and maximum HR from both sensors and used widely accepted measures of agreement to compare their performance. Results The system captured 99.8% of HR data across all matches (range 98.3-100%). The BioStamp's mean HR was 170.4 ± 20.3 bpm, while the Polar's mean HR was 169.4 ± 21.7 bpm. Maximum HR ranged from 182 to 202 bpm (Polar) and 185 to 203 bpm (BioStamp). Spearman's correlation coefficient (rs) was 0.986 (p < 0.001), indicating a strong correlation between the 2 devices. The mean difference (d) in HR was 1.0 bpm, the mean absolute error was 2.2 bpm, and the percent difference was 0.72%, demonstrating high agreement between device measurements. Conclusions It is feasible to accurately measure and monitor real-time HR in elite athletes during competition using BioStamp's and SDL's proprietary system. This system facilitates development and understanding of physiological digital biomarkers of athletic performance and physical and psychosocial demands in elite athletic competition.

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Real-Time Digital Biometric Monitoring during Elite Athletic Competition: System Feasibility with a Wearable Medical-Grade Sensor.

Background Self-reported pain levels, while easily measured, are often not reliable for quantifying pain. More objective methods are needed that supplement self-report without adding undue burden or cost to a study. Methods that integrate multiple measures, such as combining self-report with physiology in a structured and specific-to-pain protocol may improve measures. Method We propose and study a novel measure that combines the timing of the peak pain measured by an electronic visual-analog-scale (eVAS) with continuously-measured changes in electrodermal activity (EDA), a physiological measure quantifying sympathetic nervous system activity that is easily recorded with a skin-surface sensor. The new pain measure isolates and specifically quantifies three temporal regions of dynamic pain experience: I. Anticipation preceding the onset of a pain stimulus, II. Response rising to the level of peak pain, and III. Recovery from the peak pain level. We evaluate the measure across two pain models (cold pressor, capsaicin), and four types of treatments (none, A=pregabalin, B=oxycodone, C=placebo). Each of 24 patients made four visits within 8 weeks, for 96 visits total: A training visit (TV), followed by three visits double-blind presenting A, B, or C (randomized order). Within each visit, a participant experienced the cold pressor, followed by an hour of rest during which one of the four treatments was provided, followed by a repeat of the cold pressor, followed by capsaicin. Results The novel method successfully discriminates the pain reduction effects of the four treatments across both pain models, confirming maximal pain for no-treatment, mild pain reduction for placebo, and the most pain reduction with analgesics. The new measure maintains significant discrimination across the test conditions both within a single-day's visit (for relative pain relief within a visit) and across repeated visits spanning weeks, reducing different-day-physiology affects, and providing better discriminability than using self-reported eVAS. Conclusion The new method combines the subjectively-identified time of peak pain with capturing continuous physiological data to quantify the sympathetic nervous system response during a dynamic pain experience. The method accurately discriminates, for both pain models, the reduction of pain with clinically effective analgesics.

Viprali Bhatkar

Papers

A Pivotal Study to Validate the Performance of a Novel Wearable Sensor and System for Biometric Monitoring in Clinical and Remote Environments.

A novel adhesive biosensor system for detecting respiration, cardiac, and limb movement signals during sleep: validation with polysomnography.

Real-Time Digital Biometric Monitoring during Elite Athletic Competition: System Feasibility with a Wearable Medical-Grade Sensor.

Combining Electrodermal Activity With the Peak-Pain Time to Quantify Three Temporal Regions of Pain Experience