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Wearable Physiological Information Monitoring System with Remote Wireless Real-Time Monitoring Capabilities... Research Proposal · August 2011 CITATIONS

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Wearable Physiological Information Monitoring System with Remote Wireless Real-Time Monitoring Capabilities for Evidence based Stress, Hypertension, Anger, Anxiety, Depression and PTSD Recovery Assistance This project is focused on researching the feasibility of developing a monitoring system with recovery assistance capabilities to assist patients who suffer from stress, hypertension, anger, anxiety, depression and post-traumatic stress disorder (PTSD), particularly in treatment of military veterans after combat. The tool is expected to be capable of monitoring and recording patient stress conditions 24/7 or as prescribed either locally or remotely, providing therapeutic information for the patient and providing recovery-feedback information to the physician and the user. Such a system is invaluable in supporting evidence based stress, anger, PTSD management and recovery assistance. The scientists are moving forward to track and detect the events in the client’s life as they occur. The article “The Measured Life”, Technology Review August 2011 identifies some approaches that scientists are using today to analyze the relationship between physiological responses and the various emotional states experienced in daily life. This article also talks about the benefit of the detection of such events by using wearable health monitoring devices to improve the health and well being of the patient. The European Union funded project on stress analysis that involved measuring and quantifying stress in daily activities has been carried out in ETH Zurich Switzerland. This project aims to develop wearable unobtrusive physiological systems to monitor stress as they occur during daily activities. There are many devices available for providing temporary instructions for the patients under stress and PTSD conditions, such as virtual Iraq, StressEraser and Respirate, Bodymedia, Omron, polar and Zephyr. These systems have restricted capability, since they only address the temporary situation and cannot provide the feedback and assistance in real time as episodes occur during the patient’s daily activities. The proposed system to be developed in this Phase I project will be wearable and unobtrusive, detect episodes of anger, anxiety, depression, and PTSD in real time as they occur and provide instruction/recovery feedback to the patient and the doctor. These capabilities are required for evidence based therapeutic recovery programs that represent a critical need for the DoD. Moreover these existing systems cannot measure the overall recovery of the patient, keep the records of the incidences of episodes or detect an episode developing during daily activities of the patient. The existing systems are incapable of providing medical staff and the patient with information such as vital sign readings, episode characteristics and recovery (time period) of the patient required to measure the effectiveness of treatment procedures through assessment of patient condition recovery progress. Moreover these systems are not capable of automatically communicating with external patient assistance services such as their personal care provider as critical episodes develop.

Our research team proposes to research and develop a tool “Real-Time episode monitoring and instruction feedback system” based on the existing ReliSen physiological information monitoring systems. This proposed system can enhance the existing evidence-based therapeutic programs by offering new capabilities for both the patient and the patient’s medical care providers. For instance this tool will be capable of providing patient user with instructions that indicate key self-guided action steps to help them cope with elevated vital levels that occur during an episode; recovery feedback is provided to both the patient and associated doctor in real time. At the same time, the proposed tool will provide doctors with immediate feedback if and when psychological episodes occur in daily life, while measuring and recording the overall recovery progress of the patients who have begun new treatments for their conditions. One of the drawbacks for users in wearing presently available stress management systems is the obtrusive nature of the system. The aforementioned competitor systems in the market are uncomfortable to wear 24/7 and hinder user activities. Moreover these systems are incapable of monitoring user vital signs 24/7 and providing the system assistance for actions to be initiated from the patient. This user-initiated method may not be effective for episode management without a monitor, since most patients are not conscious of when to use the system when they are experiencing episodes and lack a complete understanding of how their psychological condition affects their vital sign levels. The proposed research will provide the foundation for the development of a system that is capable of providing the following benefits: 1) 24/7 monitoring of the psychological state of the patient, 2) automatic detection of the patient’s stress/anger/anxiety levels 3) provision of guidance with audio-visual feedback as needed for the patient, 4) recording of patient-generated information such as personal experience during an episode needed for clinical record keeping, 5) remote, real-time transmission of individual vital sign data obtained during the recovery period immediately following the patient’s usage of a prescribed treatment for PTSD or a similar condition 6) minimal physical hindrance to the patient that doesn’t restrict daily activities during the monitoring process. This ReliSen tool will provide the following assistance to the patient and the doctor with the ability to monitor patient recovery, and will assist doctors in determining the most effective individualized treatment methods for ensuring long-term vital sign stability among patients affected by PTSD and other anxietyrelated conditions. The ReliSen system is invaluable for both military postdeployment use and for the general population who regularly operate under extreme stress conditions. This tool will assist neurologists, veteran doctors, psychologists and other clinicians with the following: 1) identifying the causes of the stress, 2) reducing the stress that would otherwise lead to chronic health conditions, and 3) improving the patient’s general health and well-being.

This tool will also provide self-help for users who are under severe stress conditions by enabling them to reduce their stress levels through guided therapeutic healing assistance by using audio visual feedback and recovery monitoring. Moreover, this tool will be able to reduce the cost of the comprehensive medical stress treatment by at least 50% due to lower cost of monitoring device, reduced number of doctor visits and improved optimization of medication usage by at least by 50%.

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1.0 Identification and Significance of Problem or Opportunity Recent studies [Section 3.0, Ref 24] have shown that 70% of the US population has undergone a traumatic experience and around 8% of these individuals suffer from PTSD. Recent studies [Section 3.0, Ref 24] have also shown that 30% of veterans, 45% of battered women, 50% of sexually abused children, and 35% of adult rape victims are likely to suffer from PTSD at some point in their lifetimes. Fifty percent of this total group did not seek help due to the stigma associated with getting professional medical assistance/therapy to treat their condition and the fear of getting labeled with PTSD. Seventy percent of individuals with PTSD will exhibit symptoms within 3 months of the event and sometimes these symptoms will not manifest until one year after a traumatic event. Sixty-seven percent of this patient group is not placed under the category of PTSD after their treatments are completed. However these numbers may vary as no study has been conducted considering the whole population of patients who have been diagnosed with PTSD. PTSD and other stress or anger related disorders are currently treated with treatment procedures that fall under one of the four types: 1) exposure 2) cognition 3) eye movement desensitization and reprocessing EMDR or 4) medication. Other than patient re-evaluation following one of these types of treatment procedures, there is no method today for tracking and recording procedure effectiveness. There is a need to monitor the health and well-being of all service men and women – particularly war veterans – to determine whether or not they have developed PTSD or other chronic stress related conditions. For those veterans who have been identified by clinicians as having PTSD, it is critical to measure the effectiveness of these treatments by monitoring the sequence, period and intensity of the episodes as well as triggers for each episode that occur during daily activities. Ten percent of these patients under treatment have used vital sign monitors for reviewing their physiological and psychological states. However, these monitors have not been effective for 24/7 use due to their poor reliability, accuracy, lack of comfort and limited capabilities in alleviating stress conditions as they occur in everyday life situations. It is very important to monitor a patient under a treatment program for at least 2 years as the recovery may take a minimum of two years [Section 3.0 Ref 6]. One of the difficulties with determining how to decrease the required recovery period time for PTSD patients is that there is no tool currently available that can accomplish the following: 1) monitor the patient 24/7, and 2) provide the necessary information for the doctors while the patient is out of the clinic. Most of the real time stress analyzers used in clinical environments are based on heart rate, heart rate variability, ECG, galvanic skin response (GSR), respiration, and temperature [Section 3.0 Ref 19-20]. The “in vivo” stress measurement and stress analyzer tools are restricted for use in clinical environments and cannot be used in the patient’s daily operating conditions. A system is needed to assist the patient with coping mechanisms that can be employed during incidences of abnormal psychological episodes. If the patient developed aggressive, uncontrollable behavior, this system needs to be equipped with third-party "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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assistance capabilities, so that vital sign information is readily communicated to the patient’s doctor, therapist or a close personal care assistant. Moreover the system needs to provide the following benefits: 1) unobtrusive wearability to the patient 24/7, 2) reliable and accurate in measurement and transmission of vital sign data, 3) equipped with the functions needed to assist the patient automatically during daily operations, 4) ability to track incidence and severity of the episodes and 5) ability to measure the patient’s long-term recovery progress and provide the patient/user and doctor with feedback reports. 2.0 Technical Objectives *ReliSen L.L.C. has already developed the Hardware and software platform required* *for this research [www.ReliSen.com]. The primary objective of this SBIR Phase I* *research project is to research, design and develop software tools that can be used to* *characterize the patient’s psychological conditions by using physiological information* *and the development of software tools for the psychological episode recovery* *assistance. This characterization information will then be used by the ReliSen* *research team in order to develop a tool for assisting patients with psychological* *conditions. * Phase I Objectives 1. *The first objective is to develop software tools that are capable of measuring* *patient vital sign levels that relate the intensity of the stress, anxiety, PTSD, * *anger episodes occurring while the patient is conducting daily activities. * *Under this first objective, we will consider how to identify the intensity of the* *stress, anger and anxiety levels of a patient and grade them on a scale from 0-* *10. The ReliSen team will then develop the necessary software tools, by * *working closely with the clinician consultant Dr. Meghan McDevitt-Murphy. * 2. *The second objective is to research, design and develop software tools* *capable of providing patients with instructions on how to manage their* *episodes. These software tools will also provide the patient’s doctor with vital* *sign data associated with each episode information, and may be used to* *communicate this data to a third-party medical provider. The ReliSen team’s* *clinical consultants will provide guidance for the development of these software* *tools. Under the guidance of the research team’s clinician, the team will* *determine the type of instructions to be given to both the patient and their* *doctors, depending on the episode intensity level in order to guide the patient to* *expedient recovery. *

"Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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3.0 Work Plan 3.1 Introduction *The scope of the Phase I research is divided into two research objectives. The first* *research objective is to develop psychological episode characterization tools via the* *measurement of vital sign information associated with the following conditions: stress, * *hypertension, anger, depression and anxiety, which are the psychological responses* *to PTSD. * *The second research objective involves 1) researching and designing software tools* *necessary for recording and analysis of psychological episodes and 2) the* *development of software tools for patient/user instructions and guidance to be* *transmitted through the audio-visual media that are available on the hardware used as* *the baseline device. * *The final envisioned system at the end of Phase I will be comprised of a hardware &* *software demonstration platform (provided and owned by ReliSen L.L.C.), a hand held* *device with wearable physiological monitors and software tools (developed during* *Phase I-II) for the remote psychological episodes management. * *At the end of 6 months, ReliSen will demonstrate these software tools and describe* *the research and results in the Phase I final report and briefing to OSD. * *3.2 Hardware & software platform* *ReliSen has developed a commercially-proven real-time stress detection tool over the* *past 3 years for the consumer market which can be worn 24/7 by a user without* *hindering participation in daily activities [Fig-1]. Currently, the stress detection for this* *tool is based on heart rate (HR) and heart rate variability (HRV). It provides users with* *the option of programming to three zones of alarms. The system consists of a thin* *electrodes strap worn across the chest and a wrist-worn device for the display that* *indicates the alarm zones of low stress, medium stress and high stress. During Phase* *I, we will use this stress detection system together with other ReliSen physiological* *information monitoring systems including: the ReliSen respiration monitoring system, * *temperature monitoring system, GSR monitor, location monitoring system (GPS), * *blood pressure monitoring system and combined data acquisition system to provide a* *strong platform for the software tools to be researched, designed and developed in* *Phase I under the objectives discussed. * *This ReliSen platform includes the audio-visual communication capabilities required to* *remotely transfer vital sign data between the patient and the doctor. The device will* *also contain mobile communication (GPRS/UMTS) capabilities. The software will be* *built upon commercially available mobile platforms such as Mac OS, Android and* *Windows 7 mobile. This platform will be provided by ReliSen for the project. The* *development tools and software platforms necessary for the proposed Phase I will* "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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*also be provided by ReliSen L.L.C. The photo of the current system is shown in Fig-1* *and is currently the technologies covering this product are in US patent pending stages. *

Fig-1 *3.3 Military readiness of the Hardware & Software Platform* *Consultant Susan Pasternack will assist with optimizing this ReliSen platform for* *military specifications and requirements and with drafting a technology roadmap for* *potential military applications of the product. She will assist ReliSen with the* *development of a preliminary comparative assessment of its products with other* *related military technologies currently being used by the DoD. This assessment will* *include identification of additional requirements to adopt current ReliSen platforms for* *military use. * *3.4 Characterization of psychological emotions by the use of Physiological Information* *Psychological emotions such as depression, anxiety, anger and PTSD have the* *physiological responses of stress and hypertension. These physiological responses* *result in variation in vital sign levels that can be measured and monitored. The input* *vital signs parameters include heart rate, respiration rate, temperature, galvanic skin* *resistance and voice inputs. These vital sign readings will be analyzed by the software* "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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*tools developed in this proposed effort, and will detect measurable episodes of stress, * *hypertension, anger, anxiety, depression and PTSD. * *First, we will check the feasibility of developing software tools capable of using vital* *sign data to measure the intensity of the stress and hypertension episodes occurring* *while the person is conducting daily activities via the patient vital signs. In order to* *achieve this task it is important to scale the intensity of a respective episode so that* *the instructions and the guidelines can be given to the patient accordingly as well. * *Presently, doctors use subjective pain scales of 0-10 for the identification of the* *intensity of a patient’s pain. However, this subjective methodology cannot be used in* *evidence-based remote episode management tools as it depends on personal* *experience rather than based on one’s physiological data. In addition, during an* *episode the patient may not know whether he or she is undergoing an episode.* *Therefore, we cannot use scales based on personal experience for realizing these* *software tools. * *3.4.1 Intensity Scaling: Stress and Hypertension Episodes* *The intensity of the stress will be measured on a numerical scale of 0-10; a reading of* *0 indicates a negligible amount of stress and 10 represents the maximum stress level* *that a person can experience while engaging in daily operations. Software algorithms* *will be developed to scale the stress intensity using vital sign data to identify 1) stress* *intensity and the duration of stress episodes and 2) hypertension intensity and the* *duration of the hypertension. Multi-modal information derived from physiological* *information, movement information and speech information will be used to extract* *features in identifying the stress and anger characteristics. Similarly, intensity of the* *hypertension will be scaled from 0-10 by using the vital sign information as the inputs. * *These scales will be defined by using existing available clinical data. Computer* *simulations of physiological parameter variations during a typical psychological* *episode will be used to calibrate the intensity scales and test the algorithms of these* *tools. * *3.4.2 Intensity Scaling: Psychological Emotions and Episodes* *The second part of the characterization research will include the intensity scaling of* *psychological emotions and episodes such as anger, depression, anxiety, and PTSD. * *There are many methods that can be used to identify the anger of the patient. * *According to the research carried out around the world, heart rate elevations, * *breathing rate elevations and voice aggression monitoring are the best methods of* *identifying the anger of a patient [Ref 14-15]. We will use these approaches and, * *supported by clinical evidence, will define an anger intensity scale of 0-10. * *This part of the software tool will monitor the multi-modal information, identify the* *occurrence, the characteristics of the episode, record the information and forward the* *data to the instruction module of the tool. Anxiety-specific physiological, cognitive, * *behavioral and emotional effects will be analyzed together with published clinical data* "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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*to generate a numerical scale from 0 -10 for scaling the intensity of the anxiety. * *Software tools will be developed to detect and measure the intensity of anxiety attacks* *in real-life operations. Depression-specific physiological, cognitive, behavioral and* *emotional effects will be studied together with the vital sign information. The clinical* *data available in the public domain will be used in order to generate a scale from 0-10* *to measure the intensity of depression episodes. Software tools will be developed to* *identify and categorize the depression in real time as it occurs in a patient using this* *scale. For this Phase I effort, computer simulations of physiological parameter* *variations during a typical psychological episode will be used to calibrate the intensity* *scales and test the algorithms of these tools. * *The physiological, cognitive, behavioral, and emotional effects of PTSD will be* *identified using the data available in the public domain. The researchers will develop a* *scale from 0-10 and use the software tools to identify and characterize a PTSD* *episode occurring in real life. This work will be carried out under the consultation of* *Dr. Meghan McDevitt-Murphy and the supervision of Dr. Ravindra Wijesiriwardana, * *over three ReliSen engineers. The duration for this task is 12 weeks. This will be* *called “Automated Event Detection & Characterization” tool. * *3.5 Development of Software Tools for Instruction & Recovery Feedback for the Patient and Doctor* *The research team will research, design and develop software tools capable of* *providing user instructions/feedback to manage the episodes and automatically share* *the episode information with either the doctor or a third-party medical provider to* *request medical assistance as needed. Required research tasks for software tool* *development include developing the instruction and feedback databases for different* *episodes types and their intensities. The current instructions, protocols and feedback* *guidance used in the field for the treatment of respective psychological episodes will* *be added to the database so that they can be retrieved automatically in connection* *with specific episode characteristics. * *This module will receive the information including the episode type, episode Intensity* *and the vital signs data of the user from the event detection tool and will include the* *type of the episode and the intensity of the episode, as ranked on the scale of 0-10. * *Upon receiving the information, this system will initiate the recovery instruction for the* *user using the audio-visual feedback available on the device. This module will include* *user guidelines to assist the patient with expediting the recovery progress and* *recording the information. The recovery instructions include 1) breathing relaxation* *methods, 2) body tapping instructions, 3) audio-visual assistance, 4) EMDR therapy* *and 5) medication instructions. EMDR is one of the treatment methods used to treat* *PTSD patients. In EMDR treatment, a patient is subjected to the traumatic event while* *exposure to a moving object or sound frequencies stimulating the left and right side of* *the brain over time. The definition of the instructions will be carried out with the* *assistance of ReliSen’s clinical consultant. This treatment procedure will be* *implemented on the device through the audio and visual mechanism. The module will* "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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*be able to monitor a patient’s vital signs during treatment and will record the* *treatment effectiveness with vital sign feedback information (tested on human* *subjects during the Phase II). * *The module will also monitor the recovery and if the patient is not recovering well from* *an episode, the system will automatically send emergency alert information to the third* *party assistance. The location of the patient will be identified with the assistance of the* *GPS unit; location coordinates will be sent to the third party assistance as well. * *The research team will research, design and develop software tools for the doctor to* *remotely monitor the user’s condition and recovery. The tools will be equipped with a* *communication module that allows doctors to remotely logon to this system and check* *patient recovery progress. The tool would be equipped with the ability to send patient* *information to the doctor at pre-selected time intervals. The consultation for this part of* *the tool will be provided by Dr Meghan McDevitt-Murphy. This part of the work will be* *started after the completion of the event detection and will finish within 10 weeks. This* *module is called the “Instructions & Feedback” tool.* *3.6 Work Distribution of the Key Persons of the Project* *The hardware and software platform that has been described will be provided by* *ReliSen LLC for the Phase I effort. The software building parts and the deploying of* the software onto the hardware will be carried out at the Research Park University of* *Arkansas Fayetteville 72701. Three engineers will conduct these tasks under the* *guidance of the principal investigator. The software engineer with the bio-informatics* *background will test and develop the algorithms while the software programming* *engineer will generate the necessary codes for the project on the ReliSen* *hardware-software platform. The hardware engineer will test the software modules on* *the *ReliSen platform. Ms Susan Pasternack of Warrior Innovation will consult in* *getting the ReliSen hardware and software platform consistent with military usage. * *Dr. Meghan McDevitt-Murphy, Assistant Professor of Clinical Psychotherapy at the* *University of Memphis in Tennessee will serve the ReliSen team as a consultant by* *providing expert guidance in the clinical requirements for the new software tools and* *instruction guidelines to be included in the PTSD treatment assistance of this tool. She* *will consult ReliSen in optimizing the tool for use in post-deployment military mental* *health programs. Both Ms Pasternack and Dr. McDevitt-Murphy will continue to assist* *ReliSen in their capacity as consultants throughout all project phases. * *By completing these two research, design and development tasks the team will be* *able conduct the research tasks necessary for constructing prototypes to be ready for* *patient trial run testing in Phase II. * Selected References [1] http://www.wearable.ethz.ch/research/groups/health/MONARCA [2] http://www.resperate.com/us/welcome/index.aspx "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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[3] http://stresseraser.com/respiratory-sinus-arrhythmia/ [4] National Geographic - Stress, Portrait of a Killer [5] http://www.healthyplace.com/ [6]http://helpguide.org/mental/post_traumatic_stress_disorder_symptoms_treatment.htm [7] http://www.ptsd.va.gov/public/pages/what-is-ptsd.asp [8] http://www.umm.edu/altmed/articles/potraumatic-stress-000130.htm [9] http://conferences.wsu.edu/conferences/militarytrauma/presentations/2.pdf [10] http://www.emotionaltuning.com/gpage.html [11] http://video.google.com/videoplay?docid=5927814933520635461#%3Cbr%3E [12] http://healmyptsd.com/education/post-traumatic-stress-disorder-statistics [13] www.relisen.com [14] Detection of Anger Emotion in Dialog Speech Using Prosody Feature and Temporal Relation of Utterances 1th Annual Conference of the International Speech Communication Association Makuhari, Chiba, Japan September 26-30. 2010 [15] Automatic Recognition of Anger in Spontaneous Speech by Daniel Neiberg, Kjell Elenius [16] http://www.emotionaltuning.com/gpage.html/ [17] http://en.wikipedia.org/wiki/Posttraumatic_stress_disorder [18] http://www.biocomtech.com/ [19] http://www.biof.com/heartscanner.asp [20] A Multidimensional Meta-Analysis of Psychotherapy for PTSD Rebekah Bradley, Ph.D., Jamelle Greene, M.A., Eric Russ, B.A., Lissa Dutra, M.A., and Drew Westen, Ph.D. http://ajp.psychiatryonline.org/cgi/content/full/162/2/214 [21] Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson C: Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry 1995; 52:1048–1060 [22] Shapiro F: Eye Movement Desensitization and Reprocessing: Basic Principles, Protocols, and Procedures. New York, Guilford, 1995 [23] Wachtel PL: EMDR and psychoanalysis, in EMDR as an Integrative Psychotherapy Approach: Experts of Diverse Orientations Explore the Paradigm Prism. Edited by Shapiro F. Washington, DC, American Psychological Association, 2002 [24] http://healmyptsd.com/education/post-traumatic-stress-disorder-statistics [25] www.istss.org [26] www.adaa.org

4.0 Related Work Dr. Wijesiriwardana has developed wearable products for monitoring physiological information. These monitoring systems include stress detection systems that assess HR and HRV values. The stress detection and monitoring system consists of a wearable chest strap with dry electrodes and wireless transceiver and a wrist-worn watch and display unit. This water-resistant system is commercially proven and works under harsh conditions reliably and accurately. The system is comfortable to wear 24/7 without hindering the user activities. The display has three HR zones that can be programmed depending on the personal information and generates alarms as the wearer encounters stressful conditions. As episodes occur, the system prompts the user to do breathing "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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and use other relaxation techniques as required to lower the stress condition. The display feedbacks the recovery progress to the user. The initial product was launched to the market in January 2010. Selected Publications: [1] R.Wijesiriwardana “Under water wearable heart rate monitor”, U.S. Patent pending 2010 [2] R.Wijesiriwardana “Motion artifacts less heart monitoring strap”, U.S. Patent pending 2010 [3] R.Wijesiriwardana “An ear wearable heart rate and environmental information monitoring device”, U.S. Patent pending 2008 [4] R.Wijesiriwardana “ Heart rate monitoring strap”, U.S. Patent pending 2008 [5] R. Wijesiriwardana “ An ear wearable PPG sensor”, U.S. Patent pending 2008 [6] R. Wijesiriwardana “ Flexible heater”, U.S. Patent pending 2008 [7] R. Wijesiriwardana “ Real time information transmission over PSTN PSDN”, U.S. Patent pending 2008 [8] R. Wijesiriwardana “ Novel electrode arrangement”, U.S. patent pending 2008 [9] R. Wijesiriwardana “Electro-Mechanics of Conductive fabrics and E-Textiles Applications” IEEE Galveston Bay Section & NASA Symposium for Space Applications of Wireless & RFID 2007 may 8th Houston,TX,USA; Dr. McDevitt-Murphy is specialized in the treatment of PTSD among veteran patients. She is teaming with ReliSen L.L.C. as a consultant to assist with developing the Remote stress management tool solution for remote anger, stress, PTSD and other psychological disorders monitoring for military veterans. Selected Publications: [1] McDevitt-Murphy, M. E. (2011). Development of a cognitive-behavioral therapy approach to address co-occurring PTSD and alcohol misuse in OEF/OIF veterans. Professional Psychology: Research and Practice, 42, 40-46. [2] McDevitt-Murphy, M. E., Murphy, J. G., Monahan, C. J., Flood, A. M., & Weathers, F. W. (2010). Unique patterns of substance misuse associated with PTSD, depression, and social phobia. Journal of Dual Diagnosis, 6, 94-110. [3] McDevitt-Murphy, M. E., Williams, J. L., Bracken, K. L., Fields, J. A., Monahan, C. J., & Murphy, J. G., (2010). PTSD symptoms, hazardous drinking, and health functioning among U.S.OEF/OIF veterans presenting to primary care. Journal of Traumatic Stress, 23, 108-111. [4] McDevitt-Murphy, M. E., Parra, G. R. Shea, M. T., Yen, S., Grilo, C. M., Sanislow, C. A., McGlashan, T. H., Gunderson, J. G., Skodol, A. E., & Markowitz, J. C. (2009). Trajectories of PTSD and substance use disorders in a longitudinal study of personality disorders. Psychological Trauma: Theory, Research, Practice, and Policy, 1, 269-281. [5] Flood, A.M, McDevitt-Murphy, M. E., Weathers, F.W., Eakin, D. E., & Benson, T.B. (2009). Substance use behaviors as a mediator between posttraumatic stress disorder and physical health in trauma-exposed college students. Journal of Behavioral Medicine, 32, 150-161. Dr. Wijesiriwardana is specialized in wearable physiological information monitoring systems and internationally recognized for his contributions in the field.


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Dr. McDevitt-Murphy is specialized in mental disorders (PTSD) related treatment and Ms Pasternack is specialized in Military requirements for wearable Soldier systems. These distinct capabilities are the key elements for the success of this phase I efforts. 5.0 Relationship with Future R/R&D *The hardware and the software platform required for the project is already developed* *by ReliSen L.L.C. and commercially available. Software tools needed for the* *characterization of the physical and psychological symptoms will be researched,* *designed and developed under this Phase I project, using available clinical data. The* *episodes intensity scales developed in Phase I will then be tested with human* *subjects during the Phase II effort, and will be improved upon as needed. These* *software tools will provide patients and their doctors with a means of remotely* *characterizing physical symptoms based on vital sign values. It is believed that the* *system’s ability to provide immediate instruction to the patient upon incidence of* *episodes will reduce the recovery period at least by 50%. Once the scales 0-10 are* *developed for the measurement of a psychological episode, we will be able to* *categorize the patient condition more effectively (will be tested during Phase II) and* *the treatment and the recovery can be monitored much more effectively (will be tested* *during Phase II).* *The software tools that are researched, designed, developed and demonstrated in* *Phase I will pave the way for the completion of the military-specific product in Phase* *II. Once the product is military-ready, it can be used in the treatment of at least* *250,000 veterans who are diagnosed with either PTSD or other types of anxiety* *conditions.* *Phase II efforts will include the expansion of development of the software tools* *necessary for remote treatment such as drug usage information and assessment of* *the monitoring tool’s effectiveness. Development of audio-visual treatment feedback* *guidance for treatments such as EMDR and other relaxation methodologies will be* *completed in Phase II. The system’s graphical user interface (GUI) will be finalized in* *Phase II as well using feedback from the participants.* *During Phase II, this tool will be field-tested with a randomized sample of 200 PTSD* *veteran patients (100) and non-veteran patients (100) under stress conditions while* *operating their daily activities. This phase of research will focus on optimizing the* *stress detection, episode intensity identification, and testing the automated alarming* *capabilities in the field. Characterization of episodes will be tested, and parameters* *and values of the physiological measurements will be estimated for a given episode’s* *value. After the characterization process is completed, test results of these clinical trial* *data will be used to apply for the US-FDA approvals of the device under Class II. This* *device is expected to be classified under FDA class II category and ReliSen has* *already got the consultation form third party (www.provenprocess.com) FDA* *consultants with a projected time line of 18 months.* "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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*Product optimization and production cost reduction will be performed during Phase II* *in order to mature the product for the pre-production phase. Moreover, the product will* *be benchmarked with the other competitive products and technologies in the market,* *including StressEraser, Respirate and Bodymedia products/technologies. * *ReliSen has done comparative testing of its products with competitor technologies on* *the market, and comparative analysis for future competitive approaches including 1)* *nano-technology based (carbon nanotubes based) sensory systems, 2) platforms* *based on organic electronics/fabric electronics with e-printing technologies and 3)* *RFID based technologies. ReliSen’s products have shown around 90% higher* *performance over these technologies and their products with respect to reliability,* *accuracy, comfort, and operation under harsh conditions and in daily activities. * *The proposed product is not currently available in the market. Better treatment is* *needed for patients who suffer from anxiety-related conditions in order to reduce the* *length of their recovery period and reduce the number of required doctor visits by as* *much as 50%. There is no device in the market today capable of providing the* *combined services that this product would offer for remote patient monitoring. * *The product will be introduced to the ReliSen business partners in the USA and then* *China for initiating the commercialization at the end of the Phase II. * *ReliSen will introduce this system for research institutes such as the University* *of Arkansas for Medical Sciences (UAMS) to use in their research on treatment for* *stress-related health conditions such as PTSD, depression, anxiety, hypertension and* *anger. The support letter is provided in Section 11.0 page 23.* *The final envisioned system at the end of Phase II will comprise of hardware &* *software platform (provided and owned by ReliSen L.L.C.), a hand held device with* *wearable physiological monitors and software tools (developed during Phase I-II)* *for the remote psychological episode management.* *6.0 Commercialization Strategy* *This tool will be commercialized for two market segments: Military and Public.* *The US military market size for this product is based on minimally 250,000 personnel* *(http://en.wikipedia.org/wiki/United_States_Armed_Forces), but that number expands* *when discharged veterans are considered. Warfighters who suffer from anxiety* *related conditions need psychological episodes monitoring systems that are reliable,* *accurate, and comfortable and that allows for operation under harsh conditions during* *the deployments and in daily usage after post deployment. * *Introduction to the military market will be carried out through the following* *mechanisms: 1) participation in events by military organizations such as the* *Association of the United *States Army (AUSA) and national healthcare technology* "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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*conferences and trade show exhibitions, 2) distribution to third party military suppliers* *such as Raytheon and General Dynamics 3) initial use among clinical neurologists at* *the UAMS marketing to the overall VA medical system through the ReliSen website* *and via GSA scheduling of the product.* *The market opportunity for this system in the US commercial domain is around* *10,000,000 units [Section 3.0 Ref 24]. In addition to the military market needs* *discussed above the resulting products should be affordable for mental health* *practitioners and general consumers. * *ReliSen will introduce the commercial-ready version of the monitoring device to* *doctors at veteran hospitals in the region and to neighboring states of Arkansas via* *the GSA schedule. The commercial ready product has already been introduced to the* *Fire Department of Bentonville, Arkansas, and the Police Department of Bentonville,* *Arkansas, during this 2-year time period (see attached letter of support in section 11.0* *page 18). The new products resulting from SBIR investment will be marketed directly* *to nearby state and local agencies, initially leveraging these local endorsements.* *In the commercial domain, ReliSen will promote the product via its website and at* *tradeshows such as national & international medical expos. ReliSen will use its* *current commercial partners in Asia, (Shenzhen Flyever Digital Technology Limited* *and HeBei Medical authorities) to introduce the products in China and other Asian* *markets. ReliSen has already established these communication channels with the* *Asian market and will promote this product along with other complementary ReliSen* *products such as Heart monitors and respiration information monitors (see attached* *supporting documents in section 11.0 pages 20-22).* *The commercialization will start at the completion of the Phase II effort and upon* *securing FDA and SFDA (China) approvals. However, the product will be introduced * *to the markets before this approval and after the completion of the pilot run.* *ReliSen has already introduced its heart monitor, respiration monitor and* *stress monitor products to *the Asian market and will use the same channels to* *introduce this proposed product to *the same overseas markets. The Table 1.0* *below shows the estimated conservative *unit sales projections over a period of 5* *years, after first introduction of the product to *the market. The production costs of* *these sales are expected to be covered via the *ordering process by which initial sales* *deposits will be received (currently common for *such production orders). The unit* *sales volumes used for these projections are *consistent with similar health monitoring* *products’ initial sales adoption curves where *the U.S. market for new technologies in* *patient monitoring reached $3.9 billion in 2007. *This market is forecasted to increase* *to $18.3 billion in 2014, reflecting compound *annual growth of 21.3%. Out of this* *Wireless and remote patient monitors market is *accounted for 83.6% of the market in* *2009, at $4.8 billion, patient data processing *segment: Totaled $250 million in 2009,* *Transfer to electronic medical records: *Accounted for $690 million in 2009.All three of* *these areas are projected to grow by *2014, but growth in wireless and remote patient* *monitors will increase their share of *this category to 84.1% [ May 2010; Kalorama* "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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*Information Patient monitoring systems market report]. Considering the PTSD* *statistics], ReliSen opportunity market is at least 10,000,000 units at a given time in* *USA and ReliSen expect capture at least 2% (extremely conservative considering the* *combined sales & marketing capabilities with the existing wireless remote patient* *monitoring market of this product) of this market with in 5 years time from the initial* *products launch. Similar figures are expected in the China market.* US Market Year 1 5000

Year 2 10000

Year 3 50000

Year 4 60000

Year 5 60000

Consumer Market US Year 1 Year 2 10000 30000 China 10000 50000

Year 3 50000

Year 4 70000

Year 5 100000

100000

120000

150000

*Table 1.0* 7.0 Key Personnel Ravindra Wijesiriwardana (Ph.D.) was born and raised in Matara, Sri Lanka. In 2002, he graduated with a B.S. in Electronics and Telecommunications Engineering from the University of Moratuwa in Lanka with first class honors. Upon graduation, he received a full scholarship to the University of Manchester, UK to pursue a doctorate degree in Material Science. In his Ph.D. work, Ravi formulated the first theoretical model of electro-mechanics related to electro-conductive fabrics and fabric structures. His theories led to his invention of the first inductive fabric transducer, capacitive fabric sensors, fabric heaters, fabric switches and ECG measuring knitted electrodes based garments. His Ph.D. thesis "Novel Knitted Transducers" led to the filing of two international patents (WO/2004/100784, WO/2006/045988) and a university spin-off company, Smart Life Technology. Upon completion of his Ph.D. in 2005, Ravi accepted a position of Research Engineer for Textronics Inc in Wilmington, DE. He worked as the Research Engineer with smart textiles and developed the Numetrex heart rate monitoring bra. In 2006, Ravi he was granted a US green card under the category EB1: a green card category for persons with extraordinary ability and contributions. In 2008 Ravi launched ReliSen L.L.C. in Bentonville, AR. ReliSen specializes in real time wearable physiological and environmental information monitoring systems. ReliSen’s first product developed in 2008 was a heart rate monitor that works reliably and accurately under water and in extreme active conditions. This system features 24/7 comfortable wearability and operates using heart rate and heart rate variability readings. Ravi has filed more than 10 US patents for various wearable systems, including the heart monitoring product. His patent-pending inventions are in various stages of development, from prototype stages to ready for market. Ravi has published 10 scholarly journal articles in leading scientific journals, included IEEE Sensors Journal, SPIE and ISWC. He has been invited to refereed international "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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scientific conferences (ICST, ISWC) and has been an invited reader for 2010-2011 Nature Magazine. He has been an Invited speaker at trade shows (Shenzhen venture capital fair 2009 Shenzhen China). His work has been cited more than 3,000 times globally; citations to his work have been made by including NASA, MIT, Stanford, ETH (Switzerland), Bristol (UK),SIAT (China),UNSW (Australia), Darmstadt (Germany), KAIST(Korea), IIT (India), Uni Tokyo (Japan), Uni HK (HK) and NUS (Singapore). Meghan McDevitt-Murphy, (Ph.D.) graduated from Rutgers University, New Brunswick, NJ, in 1997 with a B.A. inPsychology. Dr. McDevitt-Murphy holds the following degrees from Auburn University, Auburn, AL: a M.S. degree in Psychology (2001) and a Ph.D.in Clinical Psychology (2004). She worked as an intern at the Brown University Clinical Psychology Training Consortium, Providence, RI from 2003-June 2004. She was awarded with a Postdoctoral fellowship from Brown University’s Department of Psychiatry and Human Behavior & Center for Alcohol and Addiction Studies, June 2004 – June 2006. Currently, she is working as an Assistant Professor at the University of Memphis Department of Psychology. Dr. McDevitt-Murphy is specialized in treatment of PTSD among veteran patients. She is teaming with ReliSen L.L.C. as a consultant to assist with developing the Remote stress management tool solution for remote anger, stress, PTSD and other psychological disorders monitoring for military veterans. She has published more than 110 publications in leading scientific conferences, journals (Journal of Traumatic Stress and the Journal of Dual Diagnosis) and book Chapters. She was invited speaker at conferences (Conference on Returning Veterans May 2005). She has been taken leading roles in following grants including,1) K23 AA016120-01,McDevitt-Murphy (PI),July 2007 – June 2012,Total Costs $740,000,National Institute of Alcohol Abuse and Alcoholism, Family-enhanced cognitive-behavioral therapy for comorbid PTSD and alcohol abuse, Role: Principal Investigator 2) R34 MH078855-01,Ivan Miller, PhD (PI) Funded November 2006,National Institute of Mental Health, Development of a FamilyBased Deployment, Readjustment Intervention, Role: Investigator 3)Tennessee Board of Regents, Robert A. Neimeyer, PhD (PI),June 2008 – June 2009,Total costs $100,000,African-Americans in Bereavement: Longitudinal Responses to Traumatic Loss, Role: Co-Principal Investigator 4) Department of Defense, Linda Nichols, PhD (PI) September 2008 – September 2010,Total costs: $700,000,Reintegration: The Role of Spouse Telephone BATTLEMIND, Role: Co-Investigator 5) American Legacy Foundation Ken Ward, PhD (PI) December 2008 – December 2009 Total costs: $99,000, Developing a Brief Smoking Cessation/Relapse Prevention Intervention for Disaster Survivors, Role: Investigator. Susan Pasternack, principal consultant of Warrior Innovation, is consulting with ReliSen LLC to provide this solution for remote anger and stress monitoring for military veterans. Ms. Pasternack is an experienced executive in DoD strategy and business development. Her degree in electrical engineering provided the background for subsequent career growth into program management, business P&L management, "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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business development and strategic planning. She was involved in the Soldier System (wearable computing systems to provide real-time, day-night situational awareness and communications) business area since 1995 until her retirement from General Dynamics C4 Systems. During that time, Susan led the business development efforts that resulted in the successful deployment of Land Warrior systems into OIF combat in 2007, with subsequent system deployments on troops in Afghanistan. Ms. Pasternack was a recognized Soldier Advocate within the US Army community, culminating in their award to her in June 2009 of the Order of St. Maurice – an exceptional honor for a civilian. She remains involved in consulting for both large and entrepreneurial companies in the defense arena, and is also active in several military and educational professional organizations. She brings both her knowledge of the defense industry and her passion for Soldier / Marine combatant survival to provide domain expertise and applications knowledge to assist ReliSen in the product and market development for this system. Susan can also provide guidance on retaining critical support of the program within the DoD decision-making structure. 8.0 Facilities/Equipment ReliSen is a currently operating as a virtual company with team management via daily teleconferences and Internet exchanges, along with weekly project reviews and business meetings. Upon securing Phase I funding the company will move to a 300 sq foot office space at University of Arkansas Research Park Fayetteville AR. The team will use the facilities for office and development space. ReliSen has allocated the following owned and controlled equipment for Phase I project use: 1. Oscilloscope, Signal generator, and four computers, 2. ReliSen physiological information monitoring systems, including Heart Monitoring, Respiration monitoring, Temperature monitoring, Pressure monitoring, Skin impedance monitoring tools. ReliSen wireless data acquisition systems, ReliSen GPS monitoring systems Mobile communications development board. 3. Embedded systems development board and software. 4. Software programming tools. All equipment required to perform the proposed Phase I effort is currently owned and controlled by ReliSen. No new equipment is required for the proposed effort. 9.0 Subcontractors/Consultants Two consultants will be retained upon award of the proposed Phase I effort. Approximately $16,000 (90 hours combined) will be consumed by these two experts in support of the work plan described in Section 4.0. This represents approximately 10% of the proposed SBIR Phase I effort; it does not exceed the one-third subcontractor and consultant amounts legislated by the SBIR Program. No other subcontractors will be involved in the proposed Phase I effort. The Direct Consultants are: "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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- Ms. Susan Pasternack (ReliSen Consultant) Principal, Warrior Innovations, Gilbert, Arizona - Dr. Meghan McDevitt-Murphy (ReliSen Consultant) Assistant Professor, University of Memphis Department of Psychology 10.0 Prior, Current, or Pending Support None. 11.0 Support Letters for ReliSen Proposal

1.0 Supporting letter from Bentonville AR fire Department "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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2.0 Conditional Purchase Order from Shenzhen China buyer


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3.0 strategic collaboration agreement form China Shenzhen Flyever Digital Technology Limited (page 1) "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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3.0 strategic collaboration agreement form China Shenzhen Flyever Digital Technology Limited (page 2)


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3.0 strategic collaboration agreement form China Shenzhen Flyever Digital Technology Limited (page 3) "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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4.0 supporting letter for ReliSen from UAMS "Use or disclosure of the proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the Cover Sheet of this proposal."

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12.0 Summary of Cost Proposal ReliSen, LLC’s cost proposal includes costs for direct labor salaries, direct consultant costs, direct travel to DC (1 person for project kick off meeting and final report briefing), and other direct costs including a final report and publication costs( www.ISTSS.org or www.ADAA.org or AUSA’s Army Medical Exposition). The company does not require any capital equipment purchases for the proposed Phase I effort. Direct Labor is based upon annual salaries divided by 2080 hours to generate average hourly billing rates. Round-Trip Direct Travel cost estimates are based upon quotations from Expedia.com and per diem and hotel estimates taken from the Federal Travel Regulations, Domestic Rates table. Consultant Costs for Dr. Meghan McDevittMurphy and Ms. Susan Pasternack are consistent with their professions and rates. Other direct costs are estimated to be under $2000 to cover publication and miscellaneous expenses such as back-up devices. Indirect Rates: ReliSen, LLC is a new company as of June, 2011, and does not yet have an approved accounting and financial management system. The company’s financial condition has not yet been reviewed by any government agency. ReliSen, LLC has retained the services of experts to assist in establishing the financial and accounting management systems to satisfy federal government requirements. We are working closely with an experienced executive with federal contracting experience who teaches new ventures to pursue SBIR Program funding. Mrs. Sharon Ballard, President/CEO of EnableVentures, Inc. ([email protected]) and Mr. Kenneth Soucy, CPA ([email protected]), a former supervisory auditor with the DCAA, will be assisting the company in the creation of an initial forward-looking indirect rates proposal as a result of detailed operating budgets for the remainder of fiscal year 2011, as well as 2012. This indirect rates proposal will be ready to be submitted to DCAA or other appropriate agency for review and approval by first quarter of FY 2012. An initial combined overhead/general and administrative/fringe indirect rate of 40% was applied to the Direct Labor in the preparation of this cost proposal, based upon an initial 1-year operating budget. A fee of 7% has been priced in this proposal to support essential but unallowable expenses such as legal costs associated with incorporation and initial fund-raising activities for commercialization efforts, and bank interest. The cost proposal and this summary contains salary, and indirect rates information which ReliSen, LLC considers proprietary and requests that this information not to be released to persons outside the Government except for purposes of funding evaluation.


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