Matthew D. Tarler, Ph.D. - US grants

DESCRIPTION (Adapted from the applicant's abstract): This program will develop and test a novel device that is capable of detailed monitoring and data logging of pressures applied to the foot of diabetic patients during daily activities. The device is intended to be used by a health care practitioner, such as a pedorthotist or orthotist, whose objective is to prevent foot ulcerations by reducing the repetitive stress applied daily to high risk areas of the plantar surface (e.g., heels) of diabetic patients with loss of protective sensation. The proposed device will be a quantitative tool that provides valuable detailed information regarding the applied local pressures to the diabetic foot on a step by step basis during several weeks of normal activities. A data base will also be created to store such data to provide physicians an enhanced source for information on diabetic foot care. It also provides a percent efficacy quantitative measure of orthoses. The ultimate goal is to reduce the tragedy of limb amputations resulting from diabetic foot ulcerations. The Diabetic Foot Pressure Monitor is capable of detailed on-line monitoring and logging of repetitive stress exerted to high risk areas of the plantar surface of the foot of diabetic patients with no protective sensation. It also records information about pressures exerted at each time and in every step taken for up to three weeks of normal daily activities (one week in Phase I), to provide the clinician a record of patient progress with the prescribed treatment protocol. This will provide data for improved, more quantitative treatment strategies. A reduction in the number of diabetic foot ulcers would save several hundred million dollars per year in the US alone. The Diabetic Foot Pressure Monitor would also decrease emotional stress in the diabetic community and their families, and eliminate the loss of mobility and productivity that results from amputation. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

This project will develop the Pressore Alert system, a pressure relief reminder and compliance system capable of monitoring complete unassisted pressure reliefs (push-ups), and lateral weight shifts. The Pressore Alert, which includes alert unit, single or dual seat sensor, and vibrator, will remind the user to perform a pressure relief when the programmed seated duration has expired without a pressure relief. This feedback will be an audible beeper or a vibratory buzz. The unit can store up to 6 months worth of data, which can be downloaded into the Clinician software for analysis. The clinician software can also be used to program the Pressore Alert with the duration of seated pressure before a relief alert. In addition to developing the System, Phase II will conduct clinical trials on the effectiveness of the Pressore Alert on pressure relief training and compliance. A 6 week cross-over study, and a 6 month long term compliance study will investigate the usefulness of the device in short and long term pressure relief therapy compliance This data will be the start of a pressure relief database which will house and correlate seating and pressure relief history as it is applied to the development and/or prevention of pressure ulcers. PROPOSED COMMERCIAL APPLICATIONS: The device will be marketed as a Pressore Alert(TM) system, capable of training and monitoring pressure relief behavior for individuals who perform complete unassisted reliefs, and those who perform lateral weight shifts. Distributed by clinicians, and purchased by individual users, the Pressore Alert will be used to train users to perform pressure reliefs, and to monitor long term compliance to pressure relief therapy.

DESCRIPTION (Verbatim From Applicant's Abstract): 58,800.000 Americans have one or more types of cardiovascular disease (CVD). A need exists for patients to be able to have long-term recordings of patient's ECG without burdening the patient with a large. Pager, size-device or to require the patient to take positive actions. This program will develop a miniature, single channel wireless physiological monitor transmitter that will allow ECG to be monitored and instantaneously transmitted without any action by the patient. It will provide a link between the patient's heart and the physician's computer. The physician will be able to see the ECG of the patient at any time, whether the patient is in the hospital, at an extended care facility, or at home or work by using the local Ethernet within the hospital or telephone network when outside the hospital. It will also record the ECG on a personal computer for months or years if desired. This is particularly important for syncope monitoring. The patient need not push a button or call on the telephone. Everything is done automatically. Finally, it will call 911 or other emergency numbers when physician programmed conditions are detected by the software, without any action by the patient. PROPOSED COMMERCIAL APPLICATION: In addition to being use to monitor physiological parameters on cardiac patients, the telemetry system can be used to communicate the EEG, EMG, or a vital sign from patients in the hospital or a home without interfering with similar systems of other patients. The same unit has numerous industrial and commercial applications for real time control and monitoring. The system can also be used for markets as diverse as conducting special studies in the workplace to controlling virtual reality games.

DESCRIPTION (provided by applicant): The Automated Pressure Detection and Relief Stimulation system is a portable device that provides users with feedback when a pressure relief should be performed. If the user does not or can not perform an adequate pressure relief, the unit uses electrical stimulation to produce muscle contraction and produce a change in the pressure profile. This change in pressure profile will allow the blood to perfuse to the areas of concern. This unit will also be used to monitor and record the pressure, over the course of many months, present in two locations, typically the ischial tuberosites are the points of most concern. Through clinical trials, the goal of this program is to prove that this automated pressure detection and relief stimulation system will help prevent pressure ulcer formation. The ultimate goal is to reduce the occurence of pressure ulcers and the tragedy of associated complications, including infection of the ulcer, loss of mobility and decreased productivity. PROPOSED COMMERCIAL APPLICATION: The primary target for this device is for spinal cord injured patients who can not or do not perform their regular pressure relief routine. Non-spinal cord injured patients who are also wheel-chair bound due to broken bones, surgical recovery or old age can also benefit from this device, This device can also be slightly modified to provide exercise stimulation to increase muscle mass and tissue integrity in any patient suffering from muscle atrophy.

DESCRIPTION (provided by applicant):58,800,000 Americans have one or more types of cardiovascular disease (CVD). A need exists for patients to be able to have long term recordings of patient's ECG without burdening the patient with a large, pager-size device or to require the patient to take positive actions. This program will develop a miniature, multi-channel wireless physiological monitor transmitter that will monitor and instantaneously transmit ECG without any action by the patient. It will provide a link between the patient's heart and the physician's computer. The physician will be able to see the ECG of the patient at any time, whether the patient is in the hospital, at an extended care facility, or at home or work by using the local Ethernet within le hospital or telephone network when outside the hospital. It will also monitor the ECG on a personal digital assistant (PDA) and then synchronize the data to a personal computer for months or years if desired. This is particularly important for syncope monitoring. The patient need not push a button or telephone anyone; everything is done automatically. It will call 911 or other emergency numbers when physician programmed conditions are detected by the software, without any action by the patient.

DESCRIPTION (provided by applicant): This program will develop a low cost sensor mat to monitor an individual?s body position while sleeping. Presently, the only systems that monitor body position in a bed without any wires or sensors attached to the person are designed for high-resolution analysis of the pressure and change in pressure distribution therefore using 200+ sensors and require expensive and complicated systems. A low cost system that can identify the approximate body position, or more importantly changes in body position would be a valuable tool in both research and clinical application. The goal of this proposal is to test and identify the minimum number of sensors that are required to identify body position changes and produce a Low Cost Mattress Sensor for Body Position Monitoring (Mattress Sensor). One application for this Mattress Sensor, which is applicable in both the research and the clinical settings, is the monitoring and recording of a subject?s body position, movement and transitions during sleep studies. With the addition of some electronics, the Mattress Sensor will be useful in the clinical setting to alert a caregiver when a patient has not performed a significant change in the pressure distribution and is at risk of forming a pressure ulcer. As opposed to other fall prevention systems, appropriate electronics with the Mattress Sensor can be used before the patient falls or leaves the bed, to notify a caregiver when a patient is at the edge of the bed and at risk of falling or getting out. PROPOSED COMMERCIAL APPLICATION: The device can be used during sleep studies to identify patient movements. The device can be used in hospital and long-term care facilities to reduce pressure ulcer formation or notification when a patient leaves or is about to leave the bed.

DESCRIPTION (provided by applicant): Patients with diabetes mellitus (DM) and peripheral neuropathy (PN) are at high risk for lower extremity skin breakdown and subsequent amputation. Magnitude and repetition of pressures are important indicators of skin breakdown and formation of neuropathic ulcers. Currently, there are no devices that can easily and unobtrusively measure the repetition of pressures and total weight-bearing time over a prolonged period of time (e.g., 2 weeks). The most common method of treatment of these neuropathic ulcers is off loading weight over the ulcer site using a total contact cast (TCC) or an ankle foot orthosis (AFO). The primary purpose of this grant proposal is to develop an unobtrusive, self-contained, inexpensive device that can fit inside a shoe, cast, or AFO, that will record and time stamp steps, average pressures, and weight-bearing time for "at-dsiC patients for extended periods of time. The completed Clinical Step Recorder (CSR) system will be validated with patients currently using a TCC, and subjects wearing shoes with orthotic inserts. The CSR device will have many other uses, including that of an activity monitor for patients with obesity, or the elderly, which could help assess weight-bearing activities and encourage regular physical activities.

DESCRIPTION (provided by applicant): Patients with diabetes mellitus (DM) and peripheral neuropathy (PN) are at high risk for lower extremity skin breakdown and subsequent amputation. Excessive stresses applied to insensitive skin during normal walking, constitutes a primary contributing factor to skin breakdown. Recent literature advocates an optimal window of stress for tissue maintenance or strengthening, above or below which leads to tissue damage. The goal of this proposal is to develop instrumentation to measure, record, analyze, and provide feedback regarding vertical forces, temperature, and humidity on the plantar surface of the foot during prolonged functional activities. A data collection unit (DCU), located within the shoe, will collect, analyze, and store the data, and transmit information to the patient feedback unit (FBU) via a radio frequency (RF) link. The DCU will also download the data to a computer that will transmit the data to a central database for further analysis. The long-term goal of this research will be to determine the optimal window of stress and then ultimately prevent skin breakdown and amputation through real-time feedback and warnings to patients. This device usage may also be extended to elderly or obese patients, or for testing efficacy and efficiency of various footwear or orthotic devices.

[unreadable] DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess a wireless device for monitoring and recording movement disorders. Specifically, the device will be developed for evaluating the efficacy of treatments for Parkinson's disease. Three major symptoms of Parkinson's disease that lead to disability include tremor, bradykinesia, and rigidity. Current treatments such as pharmaceutical interventions and deep brain stimulation focus on alleviating these symptoms to improve quality of life. Objectively quantifying these symptoms will aid in evaluating the efficacy of these interventions. The project will integrate hardware and develop software algorithms to analyze, quantify, and present quantitative data to clinicians. The quantitative data will be related to the current standard for evaluation, the United Parkinson's Disease Rating Scale. The device will include clinician and research interfaces. The wireless device could provide real-time monitoring of Parkinson's at home or during activities such as gait. The final device will allow at-home studies of Parkinson's patients. Monitoring Parkinson's symptoms at home would allow physicians to capture complex fluctuation patterns of the symptoms not seen during an office visit. The device would download data collect at a patient's home to a computer at the physician's office. This will allow physicians to change treatment protocols appropriately. [unreadable] [unreadable]

DESCRIPTION (provided by applicant): This project will develop and test a thin, compliant sensor that can detect and measure the direction and magnitude of applied shear and normal forces. The ability to measure shear forces is needed in many applications including prevention of pressure sores, neural prosthesis feedback and in prosthetic limbs. For pressure sore prevention, these sensors can be used in fitting and long-term monitoring of prosthetics, orthotics and seating or bed applications. For neural prosthesis applications, these sensors can be used for foot-floor contact information in lower extremity prostheses and for finger and hand feedback in upper extremity prostheses. Clinical deployment requires sensors that are reliable, long-lived, easily mounted and cosmetically unobtrusive. The Phase I work modeled, designed, developed and tested a novel prototype sensor material that could measure the direction and magnitude of the shear and normal components of contact forces. Optimization, refinement and testing of this sensor material will be performed in this phase II. The extensive testing will include static and dynamic characterizations along with clinical real-world testing of the sensor in wheelchair and in-shoe applications. At the conclusion of this phase II, these sensors will be made available for researchers to perform new studies, previously not possible.

[unreadable] DESCRIPTION (provided by applicant): Hot flashes range from very annoying distraction to debilitating condition for the 75% or more post- menopausal women that experience them. Although many treatment options have been proposed, most of these treatments have significant risks or little to no scientific proof of effectiveness. Skin conductance has been identified as the single best objective detection of hot flashes. The proposed work will produce an improved clinical tool for detection and recording of hot flashes. This new device will be smaller and more versatile than the existing technology and most importantly virtually invisible to a bystander when being worn. The proposed device will detect and record hot-flash occurrences using skin conductance and also record user perceived hot flashes through a user activated button. Additional sensors that will work in conjunction with skin conductance measurement will further improve the reliability of hot flash measurement. This program will test each of these additional sensors for their efficacy and cost effectiveness in improving sensitivity or positive predictivity of hot flash detection, or the addition of detecting relative hot flash intensity and duration. At the end of this program, a new tool will be available to researchers for objectively validating hot flash treatment options. [unreadable] [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): Many clinical health improvements have been claimed to be possible through mind-body medicine techniques and yoga in particular. These claims are being tested throughout the scientific community to sort out legitimate claims from unsubstantiated claims. However, per RFA-AT-06-002, "understanding and accurately measuring the extent to which patients and study participants adhere to study protocols is essential to understand the dose, the efficacy, the safety, and the feasibility of the intervention." "Adherence is assessed using self- report diary measures or employing handheld devices. Both strategies are limited by potential participant bias, inaccuracy, and patient burden." This program will design, build and test a small wearable device that will monitor key physiological signals, including heart rate, thoracic and abdominal respiration rate, oxygen saturation and body position, such that patient adherence will be objectively recorded. In addition to adherence, activity performance and outcome measures will be recorded to monitor how well the exercises are being performed and how much affect the exercises have on the individuals." Although mind-body medicine techniques, and yoga in particular, have been around for a very long time and have been attributed with many health benefits, scientific evidence supporting those claims have been difficult to acquire. This program will develop a new device that will enable the scientific community to more easily perform the critical experiments that will determine which health benefits can be expected from this alternative medicine. Ultimately, a better understanding of these mind-body medicine techniques will lead to better medical treatments for everyone. [unreadable] [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): The peripheral chemoreceptors (carotid primarily, and the aortic bodies) detect changes in arterial blood oxygen and carbon dioxide, and initiate reflexes that are important for maintaining homeostasis during hypoxemia. The response to changing carbon dioxide (CO2) levels produces major changes in respiratory drive, of special importance to the control of ventilation during sleep. The carotid bodies are critical for ventilatory acclimatization to high altitude, and contribute in part to exercise-induced hyperventilation, and are critical for the generation of periodic breathing during sleep. Augmented peripheral chemoreflexes can contribute to the severity of sleep apnea, and the development of hypertension in sleep apnea syndromes. In congestive heart failure, augmented carotid chemoreflexes contributes to the increased sympathetic drive so typical of the disease. Moreover, this increase in chemoreflex gain is associated with increased mortality and periodic breathing during sleep, during exercise or even while resting wake. The term "chemoreflex-modulated sleep apnea" captures the whole spectrum of influence of the chemoreflexes on sleep-breathing. There is an unmet clinical need for the development of new therapeutic approaches for patients with chemoreflex-dependent or modulated sleep apnea, a problem especially prevalent in the congestive heart failure (CHF) population. There is currently no method to safely modulate the carotid chemoreflexes. Direct current (DC) electrical neural stimulation has a long history in experimental neurology. The carotid bodies in the neck are accessible to DC stimulation, which can both suppress or enhance neural activity. Peripheral chemoreflex excitatory (anodal) modulation could offer new treatment options for obesity hypoventilation and several neurological illnesses with insufficient central neural respiratory drive, and chronic mountain sickness, while inhibitory (cathodal) modulation could have a central role in management of central and chemoreflex modulated sleep apnea, certain forms of hypertension, high-altitude sleep fragmentation from periodic breathing, and allow safe reductions in the pathologically enhanced carotid chemoreflexes and sympathetic drive in heart failure. Transcervical DC stimulation may also be able to modulate the sensation of dyspnea in chronic obstructive lung disease. The long-term goal of this research is to develop a wearable device to safely and effectively modulate the carotid chemoreflexes. The applicants have already developed innovative new methods for phenotyping sleep apnea, and to use CO2 as adjunctive therapy for chemoreflex-modulated sleep apnea. The goal of the current Phase I SBIR proposal is to assess the safety (including adverse effects on the baroreflexes), acute physiological effects of cathodal and anodal transcervical DC stimulation in healthy volunteers, and exploratory effects on chemoreflex-modulated sleep apnea. PUBLIC HEALTH RELEVANCE: Narrative The carotid body in the neck is critical for regulating the normal amounts of oxygen and carbon dioxide in the blood in health and several disease states. There is currently no method to safely modulate carotid body activity. Direct Current (DC) stimulation can suppress or enhance activity of nervous tissue and using excitatory (anodal) DC current modulation could offer new treatment options for obesity hypoventilation and several neurological illnesses with insufficient central neural respiratory drive, and chronic mountain sickness, while inhibitory (cathodal) modulation could have a central role in management of central sleep apnea, certain forms of hypertension, poor sleep at high altitude, and allow safe reductions in the pathologically enhanced carotid body activity in heart failure. Transcervical DC stimulation may also be able to reduce the sensation of breathlessness in patients with chronic lung disease. The long-term goal of this research is to develop a wearable device to safely and effectively modulate the carotid chemoreflexes. The goal of the current proposal is to assess tolerance, safety, effects on breathing, and explore effects on central forms of sleep apnea.

DESCRIPTION (provided by applicant): The goal of the proposed project is to develop and validate a new device capable of recording the respiratory airflow without the need for a pressure cannula, thermal sensor or other sensor being attached to a patient's face. This new device will address the problem of patients not tolerating or inadvertently removing the sensor from their face while they try to sleep. Even more problematic is that the pressure cannula may not be tolerated by children, infants, and the special needs population, or even worse, the pressure cannula can actually cause obstruction or increased resistance to their airway. This new sensor will enable the collection of airflow data without the addition of any wires, tubes or other sensors on the face. This program will continue the design and development of this new sensor. Although an initial prototype was constructed, many improvements will be applied based on the experiences and knowledge gained in the preliminary data collection. A new prototype will then be bench tested using respiratory simulators and realistic models to characterize and verify the new design. The new design will then be used in a small clinical trial to collect data from a set of infants while they sleep. These infants will be dual monitored with both the new prototype sensor and the gold standard for monitoring airflow with a pneumotachograph. Forced apneas will be performed and recorded from all of the subjects. The resulting data set will then be used to further refine the algorithms and data processing to further improve the sensor output. The final configuration of the sensor and the resulting algorithms should prove to be invaluable to pediatric and special needs clinicians as well as researchers for less invasive monitoring of patient airflow. PUBLIC HEALTH RELEVANCE: The monitoring of respiratory airflow in pediatric and neonatal populations suffers from sensors that can be dislodged, are uncomfortable, and can cause increased airway resistance. This program will design, build and test a small wearable device that will monitor respiratory airflow without the need for a pressure cannula or any other sensors on the child's face. This new sensor will facilitate airflow monitoring for everyone, but the infant and neonatal population will have the most to gain from the new technology.

DESCRIPTION (provided by applicant): Although obstructive sleep apnea has received the lion's share of recognition and investigation in research and practice, more troubling forms of sleep apnea, like those that are mediated by chemoreflex instability, exist and continue to have inadequate treatment. Central apneas and periodic breathing (now called the Cheyne Stokes breathing pattern) are the classic polysomnographic markers of strong chemoreflex modulation of sleep apnea. A recently described variant, "complex sleep apnea", demonstrates sustained induction of central apneas or severe periodic breathing during positive pressure titration for what seems to be obstructive disease on the diagnostic polysomnogram. The number of the affected population is large, especially when specific populations such as congestive heart failure are considered. It is estimated that complex sleep apnea alone makes up 10%-15% of the overall sleep apnea patient population or over 1.5 million patients (assuming a conservative estimate of $10 million overall sleep apnea population). In those with significant chemoreflex modulatory effects, the probability of failure of conventional positive airway pressure therapy is high. Positive airway pressure therapies tend to flush out and reduce the level of carbon dioxide (CO2);prevention of this hypocapnia state during the application of positive airway pressure therapies is an important stabilizing factor for chemoreflex-modulated sleep apnea syndromes. The Positive Airway Pressure Gas Modulator (PAPGAM), a new class of positive airway pressure device designed to prevent chemoreflex instability by carefully maintaining CO2 levels just above the CO2-dependent apneic threshold, has shown excellent acute results. Chronic effects with a modified dead space approach, called Enhanced Expiratory Rebreathing Space, have shown some success, but are less precise than directly controlling the CO2 level. This proposal will investigate the use of exhaled air to provide the CO2 that is mixed with the inlet air of the positive airway pressure device. By controlled mixing, we hope to completely eliminate the need for the high pressure tank, or at a minimum markedly increase its life. Thus, the aim is to obtain the precision of PAPGAM treatment but with reduced cost, marked improvements in ease of use, and minimized adverse outcomes from technical failures. The goals of the phase I research include: 1) building prototypes capable of diverting or pulling the exhaled air from the patient to the inlet of the positive airway pressure device;2) determining if a passive or an active rebreathing mechanism is required;3) determining what maximum concentrations are possible using each technique;and 4) clinically assessing the system. Successful implementation will result in a poweful new treatment for chemoreflex-modulated sleep apnea. PUBLIC HEALTH RELEVANCE: Abnormal control of breathing during sleep causes central or mixed forms of sleep apnea and is especially common in heart failure and kidney failure patients. The usual treatment for obstructive sleep apnea, a mask and air pressure device, does not work well in those with central / mixed sleep apnea. Recent research indicates that the air pressure device decreases the normal level of carbon dioxide and excellent treatment results have been achieved by increasing carbon dioxide levels back to normal levels. The proposed research will develop methods to use carbon dioxide exhaled by the patient to provide stability of breathing patterns during sleep. Success in development of this device, called the Positive Airway Pressure Rebreathing Modulator (PAPREM, to be used with air pressure treatments) will markedly improve treatment of complicated forms of sleep apnea.

DESCRIPTION (provided by applicant): Patient motion is a major issue in nuclear medicine imaging studies due to the substantial time to acquire enough counts to produce clinical-quality images. Motion correction algorithms exist but have limited accuracy and effectiveness, and in many instances the only practical alternative is to re-scan the patient. Most work on patient motion sensing has focused on optical tracking systems. Although sub-millimeter accuracy has been attained in research laboratories, the cost, complexity, and line-of-sight requirement of external optical tracking systems have prevented their routine use in clinical nuclear medicine departments. There is an unmet clinical need for a practical and inexpensive patient motion sensing device for nuclear medicine studies. This is especially true for brain PET and SPECT studies which demand high resolution and accurate quantification, both of which may be severely degraded by patient motion. We propose a novel and inexpensive method for head tracking for brain PET and SPECT studies that satisfies these practical requirements. Our aims in phase I are to develop the necessary hardware and software for accurate head motion sensing and to validate this method in clinical brain PET and SPECT studies.

DESCRIPTION (provided by applicant): Obstructive Sleep Apnea (OSA) accounts for millions of people not getting adequate or restful sleep and result in loss of productivity, car accidents, and is recognized as a co-morbidity of COPD and other diseases. Snoring, a typical symptom of OSA is also a disruption to a sleeping partner with potentially similar clinical manifestations as the afflicted person themselves. One of the existing approved medical treatment options for snoring and mild to moderate OSA include oral appliances. Oral appliances offer many advantages over the traditional positive airway pressure (PAP) type of devices, including no noise, less physically annoying (to many), and ease of portability. However, oral appliances also lack the capabilities necessary for monitoring compliance and effectiveness that are needed to fulfill regulatory requirements and conduct population-based effectiveness research. The proposed work will design, develop and prototype a new system that will be incorporated into multiple oral appliances and will specifically monitor compliance and effectiveness. The phase I will successfully design, develop, and prototype a system that can be incorporated into the oral appliances. A phase II will develop and implement extended clinical protocols for testing and evaluating the clinical compliance and effectiveness of various oral appliances.