While stressful situations may be inevitable, the damage and side-effects of stress are not. There is a way to stop stress from affecting your body and mind. Fortunately nature has equipped our bodies with the perfect antidote to stress. It’s called the relaxation response.

Early on, Helicor decided to focus on creating a personal, affordable medical device. Typical medical-grade biofeedback systems cost thousands of dollars and require a person to be attached to a computer. Helicor team chose to create a unit that would be self-contained, portable and had no external wires or leads to attach. It is intended to be used for relaxation, relaxation training, and stress reduction.

After 4 1/2 years of design development, prototyping, testing, programming, and user feedback, the StressEraser was launched at the annual meeting of the American Psychological Association in August 2005. First customer shipments began in October 2005.

Biofeedback and Heart Rate Variability

The StressEraser provides a daily points-based system that allows each user to tailor the relaxation training to his schedule. The points-based system also allows the therapist to tailor the relaxation training homework to the individual treatment needs of the client.

The StressEraser personal biofeedback device is intended to be used solely for stress reduction, relaxation, and relaxation training. The device has not been clinically tested for the treatment of any psychological or physical medical conditions such as insomnia, hypertension, anxiety disorders, chronic pain, etc. The product is not intended to be used for the treatment or diagnosis of any medical condition.

The Science of the StressEraser — how it works

Your Autonomic Nervous System (ANS) controls functions in the body that normally occur unconsciously, such as heart rate, respiration rate and digestion. This system is responsible for keeping your body in a regulated, balanced state. This balance is created by the constant back and forth nature of the two primary branches of your ANS: the Sympathetic Nervous System (SNS) and the Parasympathetic Nervous System (PNS).

Your SNS is involved in mobilization responses that enable “fight or flight” behaviors known as the stress response. Your PNS is involved in “rest and renew” behaviors that enable growth and restoration and are known as the relaxation response. Parasympathetic activity is regulated by your vagus nerve. The vagus nerve is the longest nerve in your body, extending from the brain stem to the base of the spine and to several organs and your heart. When the vagus nerve activates, the relaxation response is turned on. When the vagus nerve is inactive, the relaxation response is also inactive.

Your “fight or flight” or stress response can become activated by both major and minor stressors. Even states of excitement and emotions such as anger and fear activate the SNS. The primary pacifying nerve in your body, the vagus nerve, mediates the activity of the “rest and renew” or relaxation response. Overall, activation of the PNS promotes calming so you can recuperate from day-to-day stress, keeping the ANS in balance. To know more about SNS and PNS, click here.

Ideally, the SNS and PNS operate in an evenly balanced manner, keeping your body in a state of physiological homeostasis. Although there are exceptions, in general when SNS activity increases, PNS activity decreases. In particular, when SNS activity increases, the activity of the vagus nerve decreases. SNS changes in your body are all extremely important, particularly if you are in a life threatening situation in which you have to fight or escape. When the stressful moment has passed, the PNS response kicks in to relax your body and return it to a balanced state.

Our nervous systems have not yet adapted to the type of ongoing stress we face today. Ongoing minor stresses such as traffic jams, work demands, problems at home, or financial concerns tend to build up. Emotions such as anger, fear and anxiety will cause your SNS to activate. As stress accumulates, your stress response remains active for longer than your body can handle. Your relaxation response, therefore, is less active, which throws your ANS out of balance. Over time, repeated stressors and negative emotions have a cumulative wear and tear on the body that can lead to significant health problems. This is called “allostatic load.” When you are healthy, your nervous system returns to normal functioning after a stressed situation by increasing vagus nerve activity. This helps the system to recover.

When you are faced with stress on a daily basis, however, your stress response fails to shut off in a timely manner. Allostatic load leads to reduced activity of your vagus nerve. As a result, your system becomes hyperactive or begins to burn out. Hyperactive stress responses cause your system to remain in fight-or-flight mode for an extended period of time. Burn-out inhibits both your SNS and PNS from activating. In both cases, your body becomes out of balance, making your system less flexible and less able to effectively adapt to external demands. Over time, allosatic load can cause significant health problems. There is now a large literature on the relationship to stress and disease. According to the American Institute of Stress, “it is hard to think of any disease in which stress cannot play an aggravating role.” In fact, the Institute reports that up to 90% of doctors visits are stress related.

Perhaps the two most important methods of actively triggering your relaxation response are:

1. learning to change your breathing and
2. learning to change your focus. By changing your breathing and your focus, you can increase the vagal influence on your heart—and therefore relax your body.

There is growing literature on the effects of these relaxation exercises on stress-related illnesses and performance. In particular, breathing slowly can activate the vagus nerve to help enhance autonomic control. However, slow breathing without physiological biofeedback—which provides the cues that you are doing it correctly—can actually be counter-productive because you are not breathing in sync with your nervous system.

The StressEraser is a tangible biofeedback device that was specifically designed to help you find the unique breathing pattern that maximizes RSA, maintains your focus, and most efficiently triggers increased vagal influences on your heart.

Greater variability, especially due to larger rhythmic changes associated with breathing, leads to a higher amplitude RSA wave – and therefore more parasympathetic (relaxation) activity. When there is greater parasympathetic tone, it supports health, growth, and restoration.

As you learn to find this breathing pattern, the StressEraser simultaneously guides you to focus your attention, a key aspect of proper physiological relaxation. The goal of this strategy is transform a heart rate pattern characterized by short, jagged RSA waves into one characterized by large, smooth RSA waves. The StressEraser is the only portable HRV/RSA biofeedback device that allows you to follow and manipulate your RSA wave in real time. When used properly, it enhances the state of your nervous system, while inducing feelings of calm and relaxation.

The StressEraser measures your real-time beat-to-beat heart rate via an infrared finger sensor. The finger sensor has a built-in photoplethysmograph to identify the pulsation associated with each heart beat. The StressEraser accurately identifies the time of each pulse and calculates heart rate based on the time that has elapsed between the two most recent pulses. The StressEraser plots the up and down, wavelike movement and displays the pulse rate wave on the LCD screen.

By observing the RSA wave derived from your beat-to-beat pulse rate, the StressEraser provides a window into the activity of your vagus nerve.

The StressEraser then breaks down the RSA waves to analyze the frequency of each individual wave.

Once the frequency of the wave is computed, you receive immediate feedback on whether the wave was sufficiently long and smooth to receive credit. If you are breathing in your unique optimal pattern – and have a calm, neutral mind – you score 1 point for a large smooth wave, as marked by three vertical squares. The goal is to achieve this type of wave continuously. If the wave is long enough to indicate sufficient, but not optimal RSA, the user receives 1/2 point as marked by two vertical squares. If the wave is too short, the user receives no points, as marked by one square. (Note: Seniors and beginners can set a goal for continuous two-square waves.)

The minimum suggested session is 30 points (about 5-7 minutes) with a goal of 100 points per day (approximately 20 minutes).

To achieve continuous three-square waves, you are instructed to inhale until your heart rate peaks. This point is marked by a triangle. The triangle indicates the moment that a natural burst of vagal activity is about to begin, indicating your parasympathetic response. When the triangle appears, begin your exhale and shift your thoughts to a calming focus phrase (such as counting your exhale). Then, extend your exhale until the wave begins to rise again. At the end of your exhale, inhale until the next triangle appears.

The slow breathing rate required to create this wave varies from person to person, but is usually somewhere between 4.5 and 7 breaths per minute. Your unique pattern is called your “resonant frequency.” When you attain your own resonant frequency pattern, there is a perfect phase relationship between your breathing rhythms and your heart rhythms. That is, they are in perfect sync with one another.

Breathing and heart rhythms are the two most important mechanisms involved in the neuroregulation of the heart. As with your breathing, you can consciously alter your natural heart rhythm (known as the “baroreflex”) to a certain extent. When they are in perfect sync, studies show that it helps strengthen and balance the autonomic nervous system. Once you learn to find your resonant frequency pattern, you will notice it induces feelings of mind-body relaxation.

One of the most useful features of the StressEraser is that it does not give credit if there is a disruption or “break” in the flow of a wave because of withdrawal of vagus nerve activity. These breaks might be caused by a variety of factors, including:

• Extending the exhale for too long
• Strained or improper breathing
• Excessive emotion
• Being highly distracted
• Fever or illness
• Specific medications blocking vagal regulation
• Or irregular heartbeats

The StressEraser recognizes these breaks and informs you that a disruption occurred. Since the StressEraser’s feedback is in real-time, you can immediately correct the behavior that caused the wave break. Typically, a wave break is your cue to re-focus on your breathing.

In summary, the StressEraser is a tangible biofeedback device that was specifically designed to help you find the unique breathing pattern that maximizes RSA, maintains your focus, and most efficiently triggers increased vagal influences on your heart. Therefore, the StressEraser promotes health and calmness. It can be used to reduce stress for those who have issues dealing with constant stress, brief stressors (i.e., deadlines, public speaking) or to simply enhance health, performance and overall feelings of calmness.

How to Use the StressEraser

There are two primary goals of each StressEraser session – to relax your body and to calm your mind.

1. Your first goal is to relax your body by making tall, wide, smooth waves. Because breathing directly affects your HRV, the most effective way to relax is to dramatically slow your breathing. When your waves are tall, wide, and smooth, you have engaged the natural relaxation response in your body. Repeating for 10-15 minutes at a time has a lasting effect.
2. Your second goal is to calm your mind by reducing negative emotions and thoughts. Even when you are breathing properly, negative emotions will cause your waves to get shorter or to become jagged. You can reduce negative thoughts by focusing on your waves and by counting during your exhale. This exercise will clear your mind.

Practice Slow Breathing. Before you start your first StressEraser session, it is important that you practice breathing slowly. This will give you a feel for the type of breathing you will be doing with the StressEraser. To practice, inhale for 4 seconds and then exhale for 5 seconds. Feel free to follow your watch or to simply count slowly to yourself. Continue breathing at the 4-second/5-second pace for about 2 minutes. Remember, your goal is to learn to breathe slowly – not deeply. As long as you are breathing slowly, depth will come. Your breathing should always feel relaxed, not strained. Creating a wave pattern similar to the pictures below may take a while. So take your time and do the best you can.

Your First Session

1. Press the POWER button on the right side panel (not one of the buttons on the front).
2. When prompted, insert your left index finger into the clip. Wait 5 seconds for the sensor to adjust to your pulse rate.
3. As soon as your wave appears on the screen, press the BREATHE button.
4. Whenever you are ready, inhale slowly and gently. When a new triangle appears above the wave, exhale slowly and gently. During your exhale, slowly count 1.2.3.4.5.
5. When your wave begins to rise, start your next inhale.

Note: While triangles cue your exhale, there is no cue for the inhale. If you like, you can use the squares as an approximate cue. Begin your inhale when you see the squares appear under the previous wave. Alternatively, you can count 1 second after your wave has started to rise – whichever works best for you.

Score your waves. Your goal is to consistently score 2 and 3-squares under each wave. You get no credit for 1-square waves. Each 2-square wave is worth 1/2 point. Each 3-square wave is worth 1 point. To get 2 squares, follow the instructions to create waves that are tall, wide, and smooth. Keep exhaling at the triangle and counting your exhale.

Your optimal exhale count. If 5 is an uncomfortable count for you – or if you’re not scoring 2 and 3-square waves – try exhaling for a count of 4 or 6. You can try even faster or slower, depending on your comfort level. Once you have found an exhale count that is comfortable and consistently results in 2 and 3-square waves, you have found your optimal exhale count. Continue with that count until you have scored at least 5points. (Your points accumulate in the top-left corner of the screen.)

Breathing Tips:

1. Don’t lean. For best results, find a comfortable place to sit or recline. Don’t lean forward – make sure your sitting position enables you to keep your air passages and abdominal muscles free. Breathe in and out through your nose or mouth, whichever is more comfortable for you.
2. Pursed lips. If you are having trouble breathing slowly, try pursing your lips. To do this, pucker or “purse” your lips as if you are going to whistle. This will release less air as you exhale and will help slow down your breathing.
3. Always comfortable. Remember, your breathing should always be gentle, quiet, smooth and comfortable. You should not be straining, taking long inhales, holding your breath, or doing anything that is at all uncomfortable.
4. Slow not deep. StressEraser breathing is NOT “deep” breathing. Depth will come as long as you are breathing slowly. Breathing deeply too quickly can cause you to feel dizzy or lightheaded. StressEraser breathing is like normal breathing, except it is a little slower. And of course it is synchronized with the activity of your nervous system.
5. Extend your exhale. Once you are familiar with the StressEraser and are consistently scoring 3 squares, extend your exhale as long as you can until your wave starts to rise again – then begin your inhale. Remember, you benefit from making your exhales longer and longer, as long as your breathing remains comfortable and relaxed. The idea is to extend your exhale for as long as your nervous system can handle.

If you are not able to make out the above instructions, you can watch the video to understand more.

Results may vary

The indicated use of the StressEraser is for relaxation, relaxation training and stress reduction. The StressEraser is currently being tested in numerous controlled clinical trials at leading academic institutions for stress-related issues such as Anxiety, Asthma, Depression, Insomnia, Migraine Headaches, Performance (occupational & sports), Post-Traumatic Stress Disorder (PTSD, Stress levels in physicians and pregnant women, etc

Several StressEraser studies have been completed and overall results indicate users both prefer and find the StressEraser more helpful than other relaxation techniques. Immediately after using the device, users report significant reductions in feelings of stress related anxiety, increases in feelings of calmness and relaxation, increases in cognitive performance and decreases in heart rate. Moreover, results indicate that the more efficient someone is at using the device, the more they report improvement in stress related symptoms of anxiety.

Studies reveal that the StressEraser reduces feelings of stress-related anxiety and anger, increases objective indicators of work performance, and increases heart rate variability. You can access more published work here.

Fred Muench
Stress Eraser

Fred Muench – A biography

Frederick Muench has a PhD in Clinical Psychology and is currently serving as the Director of Clinical Research and Development, Helicor, New York, NY where he is responsible for new project development, clinical trials and professional education and consulting for the StressEraser biofeedback medical device. He is also an adjunct Professor in the Department of Applied Psychology at New York University in New York, NY.

About Stress Eraser

StressEraser is an award-winning small portable medical device, that relaxes the body and calms the mind in 15 minutes. The StressEraser can be used to quiet the mind before sleeping, rapidly relieve intense stress, and even to stay calm during highly stressful situations.

From beat to beat, your heart rate reflects the activity of your stimulating and pacifying nerves. The StressEraser displays these tiny changes as a wave. By watching your wave characteristics in realtime, you learn to adjust your breathing and mental focus. This decreases the activity of the stimulating nerves (thereby decreasing stress) and increases the activity of the pacifying nerves (thereby increasing relaxation).

The StressEraser is classified by the FDA as a Class II 510(k) exempt medical device. The indicated use is for relaxation, relaxation training and stress reduction. The StressEraser is available for $299 from the StressEraser web site at http://stresseraser.com. The StressEraser is currently available to U.S. residents only.

Some of the things they discuss are:

1. Where did the idea for the device come from?

2. How does the device work?

3. How is it programmed over the web?

4. How is the device monitored?

5. Is it portable?

6. Why is the device so important?

7. What types of patients would benefit from the device? Patients with Heart disease, diabetes, hypertension, severe mental illness, HIV, transplant patients, Alzheimer’s disease. Geared toward anyone that is on a complex medication regiment. Where taking the medications at the prescribe time is critical.

8. What is the average cost? Is it covered under any insurance?

9. Who have you partnered with?

InforMedix and excelleRx Team to Ensure Consumer Adherence with Prescribed Medications

ADT and XLHealth Team to Monitor Medication Compliance of Participants in Medicare Program Utilizing InforMedix Digital Technology

10. Tell us how the University of Pennsylvania using the device?

11. Is the device patented? With a pioneer patent position and a portfolio of 29 issued and pending patents, InforMedix’ IP is on a rock solid foundation for growth.

Bruce Kehr, M.D.

Bruce is currently Chairman of the Board of Directors and CEO of InforMedix, Inc, and is the Founder of InforMedix. He is also the Chairman of the Board at the Institute on Aging at the University of Pennsylvania. Dr. Kehr is a forensic consultant in neuropsychiatry and traumatic brain injury and a practicing physician. He is the inventor of fifteen issued patents and fourteen pending patents in the United States, Europe, Japan, Canada, Australia, Mexico, and South Korea, as well as issued and pending trademarks and service marks. Since 1981, Dr. Kehr has served as founder and President of Contemporary Psychiatric Services, a psychiatric group practice. He has actively written and lectured in the field of medication noncompliance, is recognized as an expert in the field of medication noncompliance, and has lectured on neuropsychiatry aspects of traumatic brain injury. Dr. Kehr received his BA from the University of Pennsylvania, followed by an MD from the Georgetown University School of Medicine.

About InforMedix:

InforMedix boasts a strong intellectual property portfolio that includes 15 issued and 14 pending patents. Most notably, the company owns the pioneer patents to technologies that provide dose-response data, a critical component to optimizing all clinical drug trials and disease management programs. In fact, the company’s patents have been cited as prior art by patent examiners in over 150 other issued patents.

InforMedix’ patent claim protection falls into two categories. First are those that cover Med-eMonitor-like devices that contain medication containing compartments plus the patient alerting and monitoring keys and screen. Second are those that do not require the device to contain medication compartments. These claims are directed to the monitoring function and signaling of the patient, and extend into the realm of non-containment electronic diaries populated by Palm, iPaq and other PDA and PC entrants. Across these patents, the data communication may be by various means including telephone line, Internet data connection, wireless link or other interface with a communication port.

More than 65 million Americans have high blood pressure. Unfortunately, even with the traditional treatment methods of diet, exercise and medication, 70 percent of that population is unable to reach their lower blood pressure goals or can’t tolerate the side effects of medications. Leaving high blood pressure untreated can be dangerous and may lead to heart attack, stroke and kidney and heart failure.

There are alternative treatments available that can be used in conjunction with medication or other lifestyle modifications to treat this common, yet serious condition.

RESPeRATE is a personal therapeutic device that is FDA-cleared for over the counter sale and guides patients through a series of paced-breathing exercises. RESPeRATE is a safe, non-drug, clinically proven treatment option for those who have high blood pressure. The device guides patients through a series of paced-breathing exercises proven to reduce hypertension.

Mechanism:

RESPeRATE’s breathing sensor automatically analyzes an individual breathing pattern and creates a personalized melody composed of two distinct inhale and exhale guiding tones. Users listen to the melody through the headphones, and the body’s natural tendency to follow external rhythms will enable the user to easily synchronize his or her breathing to the tones. By gradually prolonging the exhalation tone to slow the user’s breathing, RESPeRATE leads the user to the therapeutic zone of less than 10 breaths per minute. Within a few minutes, the muscles surrounding the small blood vessels in the body relax, blood flows more freely, and blood pressure is significantly reduced.

RESPeRATE provides physicians with another option for their patients besides just increasing medication dosages or adding additional prescription medications to reduce high blood pressure.

As shown in seven clinical trials, RESPeRATE can lower blood pressure by up to 36 points systolic and 20 points diastolic, with average reductions of 14/8 points. On average, patients start to see significant results in 4-6 weeks, and the reductions are proven to last with continued use of the device.

RESPeRATE is available without a prescription.

The RESPeRATE device consists of a computerized control unit, about the size of a portable CD player, which is connected to a sensor that fastens around the patient’s abdomen, as well as a set of headphones. The RESPeRATE sensor analyzes the breathing rate and pattern of the user, then creates a personalized melody composed of two distinct tones: a high tone for inhalation and a low tone for exhalation. Using the body’s natural tendency to follow external rhythms, RESPeRATE gradually slows the user’s breathing rate to a “therapeutic zone” of less than 10 breaths per minute. Within a few minutes, the muscles surrounding the small blood vessels in the body relax and constricted blood vessels open up allowing blood to flow more freely-ultimately yielding a significant and lasting reduction of blood pressure.

Patients who use RESPeRATE for 15 minutes a day three to four times a week should see their blood pressure drop within eight weeks of use. Clinical studies have proven that RESPeRATE lowers high blood pressure by 14/8 points on average, with the top 10 percent experiencing a reduction of 36/20 points.

Proven To Lower Blood Pressure In 7 Clinical Studies

High blood pressure treatment options are not confined to blood pressure medications. Natural remedies for high blood pressure can be safe and effective. RESPeRATE’s ability to generate a significant and sustained reduction in blood pressure was substantiated in 7 separate clinical studies published in peer-reviewed medical journals.

• The studies compared those who used RESPeRATE for 15 minutes a day for 8 weeks to a “control” group, using a walkman with relaxing music¹, a home blood pressure monitoring ^4,5 or both ²
• Clinical studies design included four double-blind and randomized^1,2,5,8, one controlled and randomized⁴, and two open-label studies^3,6
• There were 286 participants, average age of 58
• 78% of participants were already taking blood pressure medications, a third of whom were taking more then 3 medications.
• Average initial office blood pressure of 150/90 mmHg despite using diet, exercise and/or medications.

An Important Addition to Your Blood Pressure Regimen

If you’re trying to lower your blood pressure with diet, exercise, and even medication, RESPeRATE can be an important addition. In seven clinical trials, RESPeRATE was found to be safe and effective for people from borderline to severe high blood pressure, some of whom were taking medications and some of whom were not.

RESPeRATE has been proven to be an effective high blood pressure treatment even when medications are not. A study published in the American Journal of Hypertension found that RESPeRATE significantly reduced uncontrollable blood pressure, even when three or more medications were taken at maximum dosage.

About Dr. Pugh

Dr. Guy F. Pugh recieved his BA from Wesleyan University in Middletown, CT in 1979; His MS from Indiana University, Bloomington, IN in 1981 and his MD from Harvard in 1990. He did his residency in Internal Medicine at the Portsmouth Naval Hospital in Portsmouth, VA from 1990-1991 and an Internship at Mount Auburn Hospital from 1994 to 1996.

Professional Associations:
American Medical Association; Massachusetts Medical Society; American College for Advancement of Medicine
Academic Appointment:
Clinical Instructor in Medicine, Harvard Medical School
Board Certification/Licensure:
American Board of Internal Medicine/Massachusetts

The Marino Center for Progressive Health

The Marino Center for Progressive Health was created to fill an unmet need in today’s health care landscape. We offer state-of-the-art conventional medicine combined with complementary and alternative therapies, health education and prevention programs, in a caring environment.

Our staff takes the time necessary to assess the many aspects of your health. You are a full participant in developing a health care plan custom-tailored to your needs. Whether your plan calls for the latest medical treatment, a change in diet, a chiropractic adjustment or other bodywork, a program of stress reduction, or using the services of a modern hospital, The Marino Center is equipped to serve you. We are located in Cambridge Massachusetts.

The Marino Foundation

In 1998, the Center became a non-profit foundation dedicated to the integration of the best of alternative and traditional medicines. Our mission includes obtaining funding to train our staff to become experts in this new domain, conduct scientific research to test what we do and explore many unanswered questions about human health, and to take the time to train new doctors who are entering our field. We are actively pursuing educational grants and research opportunities. We would gratefully accept charitable donations from anyone who supports our mission, and wants to contribute or be a part of what we are doing.