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PubMed2002

Wearable defibrillator.

Technological advances have increased life expectancy and improved quality of life for patients with heart disease. A new device, called the wearable defibrillator, is designed to provide monitoring and defibrillation capability for patients who have had an infarct and those awaiting heart transplantation. These two populations of patients are at increased risk of sudden cardiac death. This external wearable apparatus continuously monitors a patient's heart rhythm. The monitor is programmed to recognize the individual's heart rhythm. If the heart rhythm changes and meets criteria for a lethal dysrhythmia, the monitor will provide a series of alarms to the patient and bystanders. If the patient fails to respond to the alarms, because of loss of consciousness, the system delivers a shock to treat the life-threatening dysrhythmia. Although still in the investigational phase, this device holds promise as temporary protection for patients at risk for sudden cardiac death.

Arrhythmias, Cardiac↗
PubMed2004

Use of a wearable defibrillator in terminating tachyarrhythmias in patients at high risk for sudden death: results of the WEARIT/BIROAD.

The automatic ICD improves survival in patients with a history of sudden cardiac arrest. However, some patients do not meet the guidelines for ICD implantation or are unable to receive an implantable device. This study tested the hypothesis that these patients could benefit from a wearable cardioverter defibrillator. Patients with symptomatic heart failure and an ejection fraction of <0.30 (WEARIT Study) or patients having complications associated with high risk for sudden death after a myocardial infarction or bypass surgery not receiving an ICD for up to 4 months (BIROAD Study) were enrolled into two studies. After a total of 289 patients had been enrolled in the trial (177 in WEARIT and 112 in BIROAD), prespecified safety and effectiveness guidelines had been met. Six (75%) of eight defibrillation attempts were successful. Six inappropriate shock episodes occurred during 901 months of patient use (0.67% unnecessary shocks per month of use). Twelve deaths occurred during the study 6 sudden deaths: 5 not wearing and 1 incorrectly wearing the device). Most patients tolerated the device although 68 patients quit due to comfort issues or adverse reactions. The results of the present study suggest that a wearable defibrillator is beneficial in detecting and effectively treating ventricular tachyarrhythmias in patients at high risk for sudden death who are not clear candidates for an ICD and may be useful as a bridge to transplantation or ICD in some patients.

Death, Sudden, Cardiac↗
PubMed2005

A dynamic neuro-fuzzy model providing bio-state estimation and prognosis prediction for wearable intelligent assistants.

BACKGROUND: Intelligent management of wearable applications in rehabilitation requires an understanding of the current context, which is constantly changing over the rehabilitation process because of changes in the person's status and environment. This paper presents a dynamic recurrent neuro-fuzzy system that implements expert-and evidence-based reasoning. It is intended to provide context-awareness for wearable intelligent agents/assistants (WIAs). METHODS: The model structure includes the following types of signals: inputs, states, outputs and outcomes. Inputs are facts or events which have effects on patients' physiological and rehabilitative states; different classes of inputs (e.g., facts, context, medication, therapy) have different nonlinear mappings to a fuzzy "effect." States are dimensionless linguistic fuzzy variables that change based on causal rules, as implemented by a fuzzy inference system (FIS). The FIS, with rules based on expertise and evidence, essentially defines the nonlinear state equations that are implemented by nuclei of dynamic neurons. Outputs, a function of weighing of states and effective inputs using conventional or fuzzy mapping, can perform actions, predict performance, or assist with decision-making. Outcomes are scalars to be extremized that are a function of outputs and states. RESULTS: The first example demonstrates setup and use for a large-scale stroke neurorehabilitation application (with 16 inputs, 12 states, 5 outputs and 3 outcomes), showing how this modelling tool can successfully capture causal dynamic change in context-relevant states (e.g., impairments, pain) as a function of input event patterns (e.g., medications). The second example demonstrates use of scientific evidence to develop rule-based dynamic models, here for predicting changes in muscle strength with short-term fatigue and long-term strength-training. CONCLUSION: A neuro-fuzzy modelling framework is developed for estimating rehabilitative change that can be applied in any field of rehabilitation if sufficient evidence and/or expert knowledge are available. It is intended to provide context-awareness of changing status through state estimation, which is critical information for WIA's to be effective.

Decision Support Techniques↗
PubMed2005

Using hierarchical clustering methods to classify motor activities of COPD patients from wearable sensor data.

BACKGROUND: Advances in miniature sensor technology have led to the development of wearable systems that allow one to monitor motor activities in the field. A variety of classifiers have been proposed in the past, but little has been done toward developing systematic approaches to assess the feasibility of discriminating the motor tasks of interest and to guide the choice of the classifier architecture. METHODS: A technique is introduced to address this problem according to a hierarchical framework and its use is demonstrated for the application of detecting motor activities in patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation. Accelerometers were used to collect data for 10 different classes of activity. Features were extracted to capture essential properties of the data set and reduce the dimensionality of the problem at hand. Cluster measures were utilized to find natural groupings in the data set and then construct a hierarchy of the relationships between clusters to guide the process of merging clusters that are too similar to distinguish reliably. It provides a means to assess whether the benefits of merging for performance of a classifier outweigh the loss of resolution incurred through merging. RESULTS: Analysis of the COPD data set demonstrated that motor tasks related to ambulation can be reliably discriminated from tasks performed in a seated position with the legs in motion or stationary using two features derived from one accelerometer. Classifying motor tasks within the category of activities related to ambulation requires more advanced techniques. While in certain cases all the tasks could be accurately classified, in others merging clusters associated with different motor tasks was necessary. When merging clusters, it was found that the proposed method could lead to more than 12% improvement in classifier accuracy while retaining resolution of 4 tasks. CONCLUSION: Hierarchical clustering methods are relevant to developing classifiers of motor activities from data recorded using wearable systems. They allow users to assess feasibility of a classification problem and choose architectures that maximize accuracy. By relying on this approach, the clinical importance of discriminating motor tasks can be easily taken into consideration while designing the classifier.

Journal Article↗
PubMed2005

Wearable feedback systems for rehabilitation.

In this paper we describe LiveNet, a flexible wearable platform intended for long-term ambulatory health monitoring with real-time data streaming and context classification. Based on the MIT Wearable Computing Group's distributed mobile system architecture, LiveNet is a stable, accessible system that combines inexpensive, commodity hardware; a flexible sensor/peripheral interconnection bus; and a powerful, light-weight distributed sensing, classification, and inter-process communications software architecture to facilitate the development of distributed real-time multi-modal and context-aware applications. LiveNet is able to continuously monitor a wide range of physiological signals together with the user's activity and context, to develop a personalized, data-rich health profile of a user over time. We demonstrate the power and functionality of this platform by describing a number of health monitoring applications using the LiveNet system in a variety of clinical studies that are underway. Initial evaluations of these pilot experiments demonstrate the potential of using the LiveNet system for real-world applications in rehabilitation medicine.

Journal Article↗
PubMed1999

[Design and development strategy for wearable and implantable artificial endocrine pancreas].

The ultimate goal of development of an artificial endocrine pancreas is for long-term strict glycemic control, and therefore, the trend in development is now from bedside-type to wearable- or implantable-type. With either a miniaturized extracorporeal glucose monitoring system based on microdialysis sampling method or a ferrocene-mediated needle-type glucose sensor covered with highly biocompatible membrane, and with subcutaneous insulin infusion algorithm using short-acting insulin analogue, long-term physiological glycemic control could be obtained by wearable artificial endocrine pancreas. The next step will be directed to the implantable one. Non-invasive infrared absorbance spectroscopy to fit into an artificial tooth prosthesis, an implantable artificial endocrine pancreas, in which measured glucose concentrations are transmitted telemetrically to implanted computer and pump system, might be developed.

Equipment Design↗
PubMed2002

The digital hearing aid, wearable computing, and electrophysiological response.

Presbycusis is the most common form of hearing loss caused by aging and long-term exposure to sound energy. This type of ailment decreases the ear's ability to perceive high frequencies and localize sound, thus making comprehension more difficult. To compensate for this loss, the choice of a digital hearing aid has become more common. However, most digital hearing aids do little more that their analogue predecessor's by providing a single, fixed hearing response. Such a fixed response is not suitable for all of a user's auditory environments and typically causes a more rapid loss of hearing. Significant advancement in processing power and reduction in size of computing hardware has produced increasingly more powerful, more portable, and more personal computing devices. These advances have spurred research and development of wearable computing devices towards integrating both man and machine. By definition, the digital hearing aid is a wearable computing device. The development of a digital hearing aid with increased onboard processing that is aware of its owner's electrophysiological and auditory environments is an obvious progression. This awareness will give the hearing aid the ability to autonomously modify its own parameters to improve audibility and comprehension. Electrophysiological signals can be classified as naturally occurring or voluntarily controlled. Employing these signals will allow the hearing aid to adapt to its owner's external and internal stimuli. Research and initial experiments into the monitoring and use of electrophysiological response for the control of the digital hearing aid shall be presented.

Electroencephalography↗
PubMed2004

How wearable technologies will impact the future of health care.

After four hundred years of delivering health care in hospitals, industrialized countries are now shifting towards treating patients at the "point of need". This trend will likely accelerate demand for, and adoption of, wearable computing and smart fabric and interactive textile (SFIT) solutions. These healthcare solutions will be designed to provide real-time vital and diagnostic information to health care providers, patients, and related stakeholders in such a manner as to improve quality of care, reduce the cost of care, and allow patients greater control over their own health. The current market size for wearable computing and SFIT solutions is modest; however, the future outlook is extremely strong. Venture Development Corporation, a technology market research and strategy firm, was founded in 1971. Over the years, VDC has developed and implemented a unique and highly successful methodology for forecasting and analyzing highly dynamic technology markets. VDC has extensive experience in providing multi-client and proprietary analysis in the electronic components, advanced materials, and mobile computing markets.

Biomedical Technology↗
PubMed2004

Market research on garment-based "wearables" and biophysical monitoring and a new monitoring method.

Technology advancements are foremost on the minds of scientists and developers who are working to overcome the many hurdles associated with bringing consumers the enhanced benefits associated with next generation wearable health systems. Often the technology work takes a front seat to the basic requirements of traditional consumer apparel. The choices of what consumers elect to place and carry on their body can be practical, logical, emotional and sometimes seemingly random. By providing insights and data to support the claims, developers of wearable health systems of the future will be able improve their chance of consumer adoption and continued use by gaining a clearer picture of the people that will be wearing the systems. Results from 5 different consumer research studies are presented, examining consumer buying patterns, gender differences, regional differences, their receptivity to health benefits delivered via clothing and what they want from technology enhanced clothing. Market research related to biophysical monitoring utilizing smart fabrics or interactive textiles show a critical level of commercial activity. Medical applications focused on the aged, infant and critical patient care are taking the lead. This paper presents a look at the biophysical monitoring market and discusses new materials useful in garment systems and the challenges remaining for their development and integration with textiles. A new method of non-invasive monitoring of periodic activity is discussed.

Biosensing Techniques↗
PubMed2004

e-Health and quality of life: the role of the Wearable Motherboard.

It is hard to place a price tag either on human life or on the quality of life. Technology is the key to enhancing the quality of life for everyone in the continuum of life from newborns to senior citizens--whether it is the safe delivery and care of undernourished premature babies, or extending the life of a senior citizen through exploratory treatments and procedures. Technology has the potential to rapidly transform healthcare and the practice of medicine by improving the quality and safety of patient care and increasing the efficiency of healthcare providers. Moreover, the healthcare industry must meet the challenge of balancing cost containment with maintenance of desired patient outcomes and this can be accomplished through the adoption of technology. Any technology that can minimize the loss of human life and/or enhance the quality of life has a value that is priceless. An overview of the key challenges facing the practice of medicine today is presented along with the need for technological solutions that can "prevent" problems. The paradigm of "e-Health" is discussed. Then, the development of the Wearable Motherboard as a "platform" for sensors and monitoring devices that can unobtrusively monitor the health and well-being of individuals (directly and/or remotely) is described. This is followed by a discussion of the applications and impact of this technology in the continuum of life--from preventing SIDS to facilitating independent living for senior citizens. Finally, the future advancements in the area of wearable, yet comfortable, systems that can continue the transformation of healthcare and e-Health to i-Health (for interactive health)--all aimed at enhancing the quality of life for humans--are presented.

Clothing↗
PubMed2005

Development of a wearable computer system with a hands-free operation interface for the use of home health caregiver.

We previously developed a network-based medical care support system called the Hyper Hospital, a computer network with an interface that is dedicated to patient care. In this study, we developed a wearable information system that is designed so that a caregiver can obtain information and control various support devices within the home-care environment. In our system, the wearable computer itself consists of a computer network built into a jacket. Each required function is implemented by a dedicated small computer connected to the in-jacket network. A new function may easily be added to the system by connecting additional computers. A network comprising such a set of single-function computers becomes a highly efficient information system when applied to health care support.

Caregivers↗
PubMed2005

Interoperability as a quality label for portable & wearable health monitoring systems.

Advances in ICT promising universal access to high quality care, reduction of medical errors, and containment of health care costs, have renewed interest in electronic health records (EHR) standards and resulted in comprehensive EHR adoption programs in many European states. Health cards, and in particular the European health insurance card, present an opportunity for instant cross-border access to emergency health data including allergies, medication, even a reference ECG. At the same time, research and development in miniaturized medical devices and wearable medical sensors promise continuous health monitoring in a comfortable, flexible, and fashionable way. These trends call for the seamless integration of medical devices and intelligent wearables into an active EHR exploiting the vast information available to increase medical knowledge and establish personal wellness profiles. In a mobile connected world with empowered health consumers and fading barriers between health and healthcare, interoperability has a strong impact on consumer trust. As a result, current interoperability initiatives are extending the traditional standardization process to embrace implementation, validation, and conformance testing. In this paper, starting from the OpenECG initiative, which promotes the consistent implementation of interoperability standards in electrocardiography and supports a worldwide community with data sets, open source tools, specifications, and online conformance testing, we discuss EHR interoperability as a quality label for personalized health monitoring systems. Such a quality label would support big players and small enterprises in creating interoperable eHealth products, while opening the way for pervasive healthcare and the take-up of the eHealth market.

Biomedical Technology↗
PubMed2006

[A novel model of the medical instrumentation--an overview of wearable sensors and systems].

The traditional medical instrumentation is now not suited for the transformation of the present healthcare model. It's an attempt to make a breakthrough on traditions to develop wearable sensors/systems. Five articles about wearable technology are selected by this special topic. And our aim is to inspire the designers of medical devices to grasp the chance and to take a vigorous action on innovatory developments, so as to satisfy the huge requirements of the healthcare market, and to open a new era of the medical device industry.

Clothing↗
PubMed2006

[M-health: trends in wearable medical devices].

This paper focuses on the trends in wearable medical devices for the applications in m-health. The state-of-art technologies for the continuous and noninvasive measurements of physiological parameters, implementation platforms of wearable medical devices - e-textile, and body sensor networks are reviewed here with examples of related recent research projects conducted in different countries. In addition, we introduce our recent research project on the e-textile-based health shirt (h-shirt), which can measure arterial blood pressure noninvasively, continuously and cufflessly.

Biomedical Technology↗
PubMed1988

Fail-safe systems for the wearable artificial endocrine pancreas.

For the long-term clinical use of the wearable artificial endocrine pancreas, a fail-safe system is an essential mechanism. Several hardware alarm systems have been incorporated for battery-down, and short-run of the pumps. Software alarm systems for overflow or underflow of the AD converter, empty bags, hypoglycemia, hyperglycemia, abnormal values of parameters, and excessive insulin infusion have also been built into the system. The software noise filter was effective in eliminating superimposed artificial noises and the noises induced by muscle exercise. Sudden changes in sensor output during glycemic control of diabetics due to short circuit, or disconnection of the sensor lead, were detected as overflow or underflow of the AD converter. A gradual change in the sensor output was heralded by the hyper- or hypoglycemia alarm sound. These data indicated that the fail-safe system built into the wearable artificial endocrine pancreas is useful for the long-term glycemic control of diabetics.

Blood Glucose↗
PubMed1997

Closed-loop subcutaneous insulin infusion algorithm with a short-acting insulin analog for long-term clinical application of a wearable artificial endocrine pancreas.

Considering the management and safety of the insulin delivery route when a wearable artificial endocrine pancreas is applied to ambulatory diabetic patients on a long-term basis, we developed a s.c. insulin infusion algorithm by analyzing the dynamics of a s.c. injected short-acting insulin analog (Insulin Lispro) by a three-compartment model. Principally the insulin infusion algorithm was developed as a transfer function with the first-order delay in both proportional and derivative actions to blood glucose concentrations. The parameters for this algorithm were calculated to simulate a physiological plasma insulin profile as closely as possible. By applying this algorithm with regular insulin, diabetic patients showed a 2 h postprandial hyperglycemia and a delayed hyperinsulinemia, followed by hypoglycemic episodes 4-5 h after oral glucose load, just as observed in the computer simulation study. However, using Insulin Lispro, a near-physiological glycemic control (postprandial blood glucose of 153.1 +/- 8.3 mg/100 ml at 60 min and 90.3 +/- 7.1 mg/100 ml at 180 min, respectively) could be achieved without showing any delayed hyperinsulinemia or hypoglycemia. Daily glycemic excursions were also controlled near-physiologically and although the daily insulin requirement (731.7 +/- 160.5 mU/kg/day) was slightly higher, it was not significantly different from that with i.v. insulin infusion (622.3 +/- 142.6 mU/kg/day). These results indicate that the application of s.c. insulin infusion algorithm with Insulin Lispro is feasible for long-term glycemic control with a wearable artificial endocrine pancreas in ambulatory diabetic patients.

Adult↗
PubMed2026

Wearable Sleep Monitoring in Pediatric Acute Lymphoblastic Leukemia: Associations With Subjective Sleep Ratings and Neurocognitive Functioning.

BACKGROUND: Sleep disturbances are associated with increased fatigue, reduced quality of life, and neurocognitive dysfunction and have emerged as a common complication among pediatric cancer survivors. Sleep disturbances are particularly concerning given their potential to exacerbate existing neurocognitive impacts of cancer treatments. This pilot study examined the feasibility and acceptability of a home-wearable EEG-based sleep device (Sleep ProfilerTM) for acute lymphoblastic leukemia (ALL) survivors as well as associations between specific sleep parameters and neurocognitive functioning. PROCEDURE: Children (ages 8-12; M = 10 years, SD = 1.6; N = 23) >6 months post-treatment for ALL were enrolled at clinical visits and wore the Sleep ProfilerTM for two consecutive nights at home, followed by neurocognitive testing of attention, inhibitory control, working memory, and processing speed. Parents completed subjective measures of child sleep, anxiety, depression, and acceptability. Feasibility reflected the percentage of children wearing the device at least one night and the percentage of nights with good EEG quality data. RESULTS: All participants wore the device both nights, with 84% meeting the threshold for good quality measurement. Few children met recommended quantity and quality sleep thresholds based on objective measurement, including 5 patients with elevated snoring levels; 43.5% of subjective ratings fell above the threshold for sleep disturbance. Greater sleep latency was associated with worse inhibitory control (r = -0.42, p = 0.046), and total sleep time was positively associated with inhibitory control and attention. CONCLUSIONS: Findings confirm the feasibility and acceptability of home EEG sleep monitoring in school-age survivors, and associations of sleep latency and snoring with reduced neurocognitive functioning may offer modifiable risk factors for aspects of neuropsychological dysfunction common in pediatric survivorship. CLINICAL TRIAL REGISTRATION: At the time this study was conducted, we were not required to register the study on ClinicalTrials.gov. It was a single-institution feasibility study without intervention, which was not considered a clinical trial.

Humans↗