Monthly Archives: September 2010

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Information and Education

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phar equip11 Information and Education

A renewed commitment to a nationwide phone reference (1-800-SLEEPLAB) is just one of many projects on the Sleep Group Solutions docket.

Rani Ben-David, president of Sleep Group Solutions (SGS), North Miami Beach, Fla, wants to be all things to all people, at least when it comes to the telephone lines. The ambitious goal comes in the form of 1-800-SLEEPLAB, a work in progress that seeks to be nothing less than the largest directory in the sleep world—an ever-widening realm that includes neurology, cardiology, ENTs, , and .

With Vital Lessons Learned
From 1-800-SNORING, a pilot project dedicated solely to the dental end, Ben-David hopes to be a first-call for consumers who need help. Depending on the zip code from where the call originates, inquiries would go straight to participating sleep professionals. who use SGS sleep interpretation and scoring services will also automatically be a part of the 1-800 directory. “Right now there is no one directory for everybody,” says Ben-David. “This one reference is designed to be the heart for everyone.” While the listing is for FREE the sleep labs and Physicians have the option to lease the 1800 number for the ZIP code they practice at for a very low fee.

SGS has built its reputation by thinking big, and when company officials needed an advisor, they went straight to the top, garnering advice from Atul Malhotra, MD, medical director for the Boston-based Brigham and Women’s Hospital (BWH) Sleep Disorders Research Program. SGS is the manufacturer of the Eccovision Rhinometer and Pharyngometer.
Jeffrey Fredberg The Harvard professor who invented the Eccovision Rhinometer and Pharyngometer recommended Malhotra, and Ben-David now counts the BWH mainstay as a friend and business associate. As both a purveyor of education and a seller of sophisticated measuring devices and other Sleep products such as the Embletta ambulatory sleep device, SGS has seen dramatic growth that mirrors the hype surrounding the burgeoning sleep industry. Plans for 2010/2011 are simple: keep it going, spread the news, and take on even more projects. That is why CEO Tamir Cohen has started a road trip to Europe and the Middle East to start partnerships in those Regions.

New Partners, New Twists, New Technology
A partnership with Newport Beach, Calif-based Glidewell Dental Lab offers SGS an opportunity to double its number of educational seminars to about 80 per year. Glidewell Doctors will now get a discounted rate. Glidewell provides a lot of dental appliances in the vast metropolis of Southern California and throughout the World. “It’s a huge partnership because they do more than 3,000 per month,” enthuses Ben-David. “Those Doctors need the education, and it’s a perfect opportunity for two companies with integrity to come together for mutual benefit. Glidewell is one of the most reputable Dental Labs in the World”.
embletta sgs1 Information and Education

The SGS educational model starts with a 2-day seminar. “Most of the professionals who lecture for us are diplomates of the American Academy of Dental Sleep Medicine,” adds Ben-David. “Doctors come to the courses very excited to learn about the field of sleep. In 2 days, we teach them about apnea, insomnia, and the main sleep problems. Of course, we cover the dental side of sleep apnea and our are very soon, busy treating patients.

emblas sgs sensors1 Information and Education
An App for That
Technology in the form of an iPhone application is designed to aid consumers, many of whom rely heavily on cell  phone information. The app records a bed partner’s snoring for 60 seconds, then features a questionnaire to fill out. “Send it to us and our server automatically sends it to the closest sleep pro in your area, and that professional is part of the 800 directory,” explains Ben-David. “The wife tells the husband that he snores. She can download the app and record him, the sleep doc will call you for the evaluation. People know they have a problem, but don’t take that extra step. Now the stalemate can be broken.” and can send the application via email as a kind of rudimentary initial screening. “It’s not a medical screening,” admits Ben-David, “but they can send it to their patients and ultimately give an opinion.” Oral Appliance for Less Yet another SGS venture with Respire Medical involves an
oral appliance at a reasonable price. “It is a laboratory-fabricated appliance at a cost of $149,” says Ben-David.  “Compare that to a well-known brand that is $550. For the patient to be able to do it, we lowered the cost of the appliance. It’s as good as everyone else’s, but at a quarter of the price. We are making enough money on the $149 that we don’t need to charge more.” The Gelb Center in New York City has partnered with SGS and Respire to offer the best solutions for Sleep Disordered Breathing. Drs Harold and Michael Gelb direct an Integrated TMJ and Sleep practice at 635 Madison Avenue together with David Walton and Walid Raad of Respire and SGS.

Rani Ben-David, President of Sleep Group Solutions is based in Miami, FL.
For more information on SGS, please visit www. sleepgroupsolutions.com

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The Heart of the Matter: with Home Sleep Testing

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The Somté testing (HST) device by Compumedics addresses the technological challenges of home studies while its sophisticated ECG capabilities help set the device apart from its peers.

When engineers from Australia-based Compumedics developed the Somté, they knew cardiology was likely to play a growing role within sleep medicine. With this in mind, they developed a Holter-type sleep system that earned a 2006 Frost & Sullivan award for Technology Leadership.

Since that time, interest in sleep disorders and testing has exploded from all sectors of medicine. Combining diagnostics with the optional capability for Holter ECG monitoring and pulse transit time results, is one way to recognize this new reality. Most other HST units do not have the option, because they don’t record electrocardiography (ECG) signals.

Jeff Kuznia, Vice-President of North American Sales and Marketing for Compumedics, says the unit’s ability to record reliable data means that the equipment fits well into the Type 3 recorder market. Holter ECG monitoring exists as a stand-alone product, but the software development required to combine it with sleep makes it difficult for other companies to make a similar device.

Compumedics’ involvement in the Sleep-Heart Health Study sparked the original Holter idea, and there are no regrets—but still some work to do. “ Most cardiologists are aware of the connection between sleep disordered breathing and cardiovascular disease. However I do not believe that many have firsthand experience with managing sleep disorders, and may not appreciate the impact that sleep disorders have on cardiovascular disease, but also the effect of treating Sleep Disordered Breathing ‘SDB’ when it comes to managing many patients who suffer from complex hypertension or cardiac arrhythmias.”

HOME TESTING: WHAT’S DRIVING THE MARKET?
Sleep Diagnosis & Therapy spoke with Kuznia about a wide-ranging discussion on the future of testing. Topics such as reimbursement and clinical efficacy are driving the market, but what shape will these changes make, and how will new discoveries alter diagnostic testing?
somte units The Heart of the Matter: with Home Sleep Testing

ARE RESEARCHERS CLOSER TO DETERMINING A FIRM LINK BETWEEN SDB AND CARDIOVASCULAR PROBLEMS?
Data is out there, but from a scientific standpoint, the issue is still one of determining causality. There definitely is clear interaction between these processes, and a lot of people with cardiovascular disease have OSA or develop CSA. However, the evidence is inconclusive in showing SDB actually leads to cardiovascular disease. If you have cardiovascular disease, chances are increased that you have SDB, which should be treated. In many patients, treating SDB improves the status of their cardiovascular disease, or improves the ability to manage that disease, but what caused the other has not been determined. With respect to “hard science” this question may be viewed as rhetorical as hopefully either diagnosis warrants treatment.

THERE IS A LOT OF COMPETITION IN HOME TESTING. WHAT MAKES THE SOMTE STAND OUT?
One of the advantages of the Somté is it has some flexibility and capabilities that a lot of the other products don’t have that are in that class. It is one of the few units that has a built-in display that allows the technician to verify the quality of the recording prior to sending the patient away, avoiding a wasted recording night. It’s easy for the patient to set it up in most cases, the Somté uses the best methods of measuring respiratory data, with built-in RIP technology.  It’s also one of the few units that provide additional inputs to record limb movement.

You’ve got the ability to look at body position with the Somté if you so desire, and you can add in these high frequency channels. There are two of them, and the original concept was they would be used for ECG, but when we released the product we made it flexible enough so they could be used for a channel of EEG or EMG, and we’ve got people that are looking at this and saying this would be a very good thing to monitor Bruxism for instance.

An operational advantage of the system is that you can preconfigure the unit for the recording. The patient can put it on themselves, and does not have to interact with the unit because it will turn on automatically, record the data, and then turn off. A lot of the people that send the units out to patients will preprogram the unit to turn on at night and shut off in the morning. All patients have to do is hook themselves up, and they do not have to worry about touching the unit and turning it on and off. So in some cases patients may come to the sleep clinic or the physician’s office, get wired up, and then they can test to make sure that everything looks good before they go home.

WHAT ARE PATIENTS SAYING ABOUT THE PRODUCT?
It’s small, lightweight, and it’s easy to wear. Some of the units out there for home studies are still fairly large and bulky. There is a comfort factor to this that comes into play, and I think we’ve addressed that effectively.

IS THE BATTLE FOR CLINICAL ACCEPTANCE OF TESTING OVER?
The vast majority of sleep professionals believe that testing is valid and appropriate in certain populations, and that it can be done reliably. There are concerns still amongst some that if everybody was evaluated with a test that we would be missing other factors and other issues involved with their symptoms, such as co-existing sleep disorders. That being said, if you go to your primary care physician complaining of stomach pain and are treated and he/she missed the fact that you had an ear infection, does this constitute “bad medicine”? It is one of these things where there are still questions in the mind of the marketplace that would only be answered when testing is done in larger numbers.

If more people are doing testing, and have a larger volume of experience, the general consensus of the marketplace may shift because they would might experience more success, or they would be able to determine when it would not be successful and be able to more clearly state which set of patients need to be done in the lab.

DO YOU BELIEVE THE POTENTIAL OF THE MARKET IS A REALITY?
We have been telling ourselves for the last 20-plus years that the number of people in the population with undiagnosed sleep disorders is large. If we are claiming that 80% of the people with sleep disorders are currently not diagnosed and treated, than there is this population of people not being cared for in our health care system. The thought was that if we had more testing being done, we would reach more patients with sleep disordered breathing and treat them, and that would be a cost effective way of managing this particular part of the health care challenge.
We don’t have a good handle on whether that is true or not. The economics are driven from the reimbursement end, whether it is Medicare or other third party payers. They look at the growth of sleep diagnostics and the cost of ongoing treatment, and are concerned at the cost and not necessarily the benefit. Anytime a diagnostic procedure or a treatment procedure has rapid growth, it puts a spotlight on it and payors look and say we maybe need to manage this more aggressively.

The issue is that if, or maybe when, reimbursement drops in the clinical lab, will it necessarily push people to doing more sleep studies in the home? This is unclear because the reimbursement at the home level is also relatively low, and so, from a business operations standpoint, to provide testing services in a manner that you can more than cover your costs is still a challenge for a lot of practitioners.

WHERE DO YOU SEE TESTING IN THE FUTURE?
There is definitely a role for testing in the whole milieu of sleep medicine, and clearly there are a lot of people, including physicians, insurers, and patients, that are very strong advocates for that approach. The concern in the minds of many sleep professionals is that sleep medicine and managing patients with obstructive is not within the general training of most internal medicine physicians and most family practitioners. You are going to have family practitioners and internists with no sleep medicine training, caring for patients who may require more complex management than just prescribing a CPAP pressure. That is precisely the reason that sleep centers should be looking at expanding into it [home testing] because it keeps the profession in the sleep home testing market.

CAN TESTING EXPAND INTO OTHER AREAS SUCH AS THE REALM OF TRUCKING?
I think you can expand trucking industry to transportation in general. The airline industry is definitely another example and here you’ve got other complicating issues. You’ve got shift work compounded with potentially a pilot that may have OSA.  Clearly anything involving hazardous waste material or in the broad category of transportation is certainly a legitimate testing population.

It is still unclear what role testing plays in that arena. For instance, the truck drivers: one of the concerns is that if you would give a recorder to a truck driver and say, “put this on and bring it back in the morning after you have slept all night,” is that the truck driver is going to take that unit home and place it on his kid and not necessarily on himself. This is one situation where it may need to be a monitored study, since you need to verify whom the recording was actually done on.

One other population is those patients who are already diagnosed, that are already on treatment but have not been reevaluated for a while. Once a patient is diagnosed with and we have put them on treatment, we often don’t know how effective the treatment is long term, or if it needs to be adjusted. This has been one of the issues with tracking compliance in the usage of CPAP over time; in many cases those patients are not retested to see if their treatment is still valid, or if it is effective from an objective standpoint. testing is an ideal way to do cost-effective follow-up.

Jeff Kuznia, RRT, RPFT
Compumedics USA Inc
Charlotte, NC
www.compumedics.com

INFO BOX
Somté Software Package Includes:
• full waveform review;
• automatic respiratory event detection and statistics (central apnea, obstructive apnea, mixed apnea, hypopnea, • SpO2 desaturation events and artifacts);
• oximetry analysis;
• full manual event editing capabilities (deletion, reclassification, marking new);
• event searching;
• ability to view patient information; and
• comprehensive report generation with user definable template
• full disclosure printing
• Optional ECG Analysis with arrhythmia detection, classification, heart rate variability and ST-Segment measurements and statistics.

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Apnea and Sedation: A Potentially Dangerous Mix

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Sleep apnea is on the rise and health professionals must implement a perioperative and periprocedure sleep apnea management program to reduce patient risk. 2

Mechanics of Sleep Apnea
Upper airway collapse is worsened during the perioperative and periprocedural care of a patient, especially if they receive premedication, general anesthesia, anxiolytics, antiemetics, and opioid analgesia.1,2,4,5  The result of decreased pharyngeal tone is reduced ventilation and oxygenation, causing hypoxia and hypercapnia, which inhibits the arousal response associated with each apnea incident of apnea. Airway obstructions also strain heart and lung function.

Premedication with drugs such as benzodiazepines has muscle relaxing effects on the upper airway musculature, causing a reduction of the posterior pharyngeal airway. The result is increased risk for hypoventilation, hypercapnia, and hypoxemia necessitating monitoring of oxygenation and ventilation.

There is considerable risk associated with premedications for procedures done outside the operating room, because we often underestimate the need for monitoring cardiovascular changes in these patients.  Capnography is a non-invasive alternative to ABGs and detects real time changes in carbon dioxide. Additionally, patients receive outpatient procedures and are sent home to recover shortly after procedure.  
Determining readiness for discharge requires defining risk factors for sleep apnea or sleep deprivation.  Routinely assessing discharge criteria will reduce the risk for problems at home.

On an intra-operative basis, these patients frequently have more difficult intubations and extubations.   They have a greater chance for adverse events due to hypoxemia, high or low blood pressure, cardiac arrythmias and aspiration pneumonias, as seen in the post anesthesia recovery unit (PACU). Discharge delays in the PACU are more likely due to an inability to maintain oxygenation at desirable levels for discharge, resulting in increased clinical care for nurses, anesthesiologists, and respiratory therapists.

Due to the risk for cardiopulmonary arrest, patients often require a discharge from PACU to a higher level of care for more exhaustive monitoring of their ventilation and increased sedation that can include telemetry, observation care for 7 hours or overnight, and even intensive care.1,2,5

Sleep patterns are changed significantly in patients recovering in a critical care unit. They have frequent interruptions that will worsen the effects of sleep deprivation, increasing the impact on sleep-disordered breathing. Treatment with positive air pressure will improve the outcome of patients with cardiac and respiratory co-morbidities, and the implications of this are significant, because sleep-disordered breathing is such a common (frequently untreated and undiagnosed) chronic disease of middle-aged adults.5

No Time to Relax
Anesthetics, analgesic, and sedative drugs produce increased muscle relaxation of the throat and tongue, and in someone at risk for sleep apnea, may create an airway blockage. When administering anesthetics, the surgeon anesthesiologist may need to alter the type and dosages of medications received to protect the breathing responses.  Post surgical pain management may also require adjustment to prevent diminished breathing. As a result, narcotic pain medication or sedation will be balanced to prevent respiratory depression.

Surgery of the upper abdomen, breast, chest, or upper airway can complicate matters for patients at risk for sleep apnea by causing increased respiratory discomfort. Respiration is shallow with these surgical procedures, and increased pain adds to this discomfort when trying to breath.

When being cared for in a supine position, added risk occurs from the relaxation of the muscles in the posterior airway. Unless contraindicated, the head of the bed should be elevated 20-30 degrees to lessen some of the force placed on the posterior airway.

Positive air pressure may be required to support breathing after surgery or after a procedure requiring sedation or pain medication, especially if depressed respiration due to decreased ventilation becomes a concern.

Deep Sleep Suffers
Patients at risk for sleep apnea experience less time in the deep levels of sleep, reducing the body’s natural capacity for healing and pain control. As a consequence, these processes work less effectively.

The states of NREM (non-rapid eye movement) and REM (rapid eye movement) each perform a different function, and both are crucial to overall daytime effectiveness. Going to sleep is like descending a stairway.  As brain activity slows, we transition into NREM sleep until we reach deep sleep. When in deep sleep, pulse and respiratory slows, blood pressure drops, muscles relax, and growth hormone is released to facilitate physical healing, enhanced pain control, and physical rejuvenation.

About every hour and a half we come out of deep sleep into REM sleep, an active state of sleep.
REM sleep is crucial since our breathing, blood pressure, pulse rate, and blood flow to the brain all increase during this phase. During REM sleep, our peripheral muscles are atonic.

REM presents a challenge to sustain breathing, oxygenation, and cardiac stability in patients at risk for sleep apnea. Clinical functions all become more difficult to sustain because apneic events are longer during REM, oxygen desaturation is lower, and more cardiac arrhythmias are noted during REM sleep. Since the longest REM period occurs in the early morning hours between 4:00 – 6:00 AM, we need to closely monitor our patients during this time.

Every stage of the health care continuum that provides sedation should implement sedation-related apnea management guidelines. This program will reduce patient risk, reduce medical liabilities, and create additional sleep apnea patient disease management revenue streams for related health professionals. 7

Christopher VuSleep Advoacate
The author is a staff writer for
Sleep Diagnosis and Therapy

References
1.    den Herder C, Risks of general anaesthesia in people with obstructive sleep apnoea. BMJ 2004; 329:955-9.
2.    Estfan B, Respiratory function during parenteral opioid titration for cancer pain. Palliative Medicine. 2007; 21: 81-6.
3.    Feinsilver, SH, A sleeping giant:  sleep-disordered breathing in the coronary care unit. Chest 2005; 127: 4-5.
4.    Morgenthaler TI, Practice parameters for the use of autotitrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome:  an update for 2007.  An American Academy of Sleep Medicine report.  Sleep. 2008 Jan 1; 31 (1): 141-7.
5.    Practice Guidelines for the Perioperative Management of Patients with Obstructive Sleep Apnea.  A report by the American Society of Anesthesiologists Task Force on Perioperative Management of Patients with Obstructive Sleep Apnea.  Anesthesiology 2006; 104:1081-93.
6.    Preventing and managing the impact of anesthesia awareness. Sentinel Event Alert Joint Commission on Accreditation of Healthcare Organizations October 6, 2004; Issue 32.

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CPAP

Beyond the S9: VPAP™ Tx Lab System

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vpaptxlab1 Beyond the S9: VPAP™ Tx Lab System

As the marketing push for ResMed’s S9™ Series reverberated around the 24th APSS (American Professional Sleep Societies) meeting in San Antonio, the San Diego-based company’s VPAP™ Tx Lab System quietly began to build its own momentum. Billed as an “all-in-one” titration solution for sleep labs, the unit contains all ResMed therapies, including adaptive servo-ventilation (Adapt SV), which treats central , mixed apneas, and periodic breathing.

According to Elizabeth Little, VPAP Tx Product Manager at Resmed, most people were surprised to hear the system includes all ResMed’s therapies. They expected Adapt SV to remain separate, and were pleasantly surprised to see it in the mix. “Our goal with the VPAP Tx was to build a product that would be easy for sleep techs to use and extremely comfortable for patients,” said Little. “We studied the work flow of technicians, and minimized the number of steps they need to take. Swapping out the bedside device for one therapy mode vs another was cumbersome, and the way to eliminate that was to put all of our superior therapies in one system. We put lab technicians’ needs at the forefront when developing this product.”

Throughout the conference, Little kept up a continual dialogue with sleep technicians and lab managers about the finer points of the new system. Little reports that many technicians were very impressed with the highly intuitive software. Among the most popular features were the therapy default settings, which are customizable and automatically reset to baseline pressure upon startup, eliminating a step for the tech, and preventing them from accidentally startling the patient with a blast of pressure. Additionally, she pointed out the “Detailed Settings Report,” which provides a complete record of all changes made to therapy during the night, giving them visibility to the performed by the techs, and allowing them to identify areas where training is needed.

A bilevel function delivers two treatment pressures—one for inspiration and one for expiration—and provides control over a variety of bilevel therapy modes. This integrated approach is a first for ResMed, and Drew Terry, senior director, product management, sleep SBU, says that a few months into the launch has seen many labs convert to the new unit with success. “The techs like the easy layout,” enthuses Terry. “They can go from CPAP mode to bi-level mode during the testing process, and it does it in an intelligent way—giving full control while also making recommendations. New technicians won’t spend a lot of time figuring out how to set things up. It’s automatic but it also allows you to make any necessary adjustments.”

After sleep lab technicians use the VPAP for titration, patients may ultimately go home with an S9 CPAP. Those that opt for this route will get many of the same features and technologies that served them during testing. “They can sleep with the Easy-Breathe Waveform, which synchronizes pressure with natural breathing patterns,” says Terry. “They will get the same ultra-quiet therapy in the home that they experienced in the lab. By maintaining consistency between the lab and home therapy, you are maximizing the patient’s chance for success.”

vpaptx2 Beyond the S9: VPAP™ Tx Lab System

Competitive Concerns
On the home care side of the sleep business, HME providers were left reeling in July when CMS announced new winning bid prices in the competitive bidding program. Unless legislative remedies derail the program, home care providers in 9 of the nations metropolitan areas will take a 32% cut in their allowable for CPAP units in 2011.

Currently, sleep labs must refer all CPAP patients to an HME to fulfill the prescription. “Some reports have shown that more people are considering dispensing, and that is something sleep lab owners may consider when looking at all the forces on their business,” says Terry. “Getting into the home care side of the business is another opportunity, and I think a lot of people are considering it. It’s a relatively small percentage of labs that are doing it right now—probably less than 20%. It’s a different business than running a lab.”

It is a competitive business environment for labs and many labs are looking for additional ways to serve their patients and grow their business. “They are considering how they might include in their service offerings,” says Terry. “Although the revenue for a home test is less than what the in-lab tests are, labs are looking at that as a way to bring in additional patients who maybe would not have come into the lab anyway.”

S9 Still in Spotlight
Despite reimbursement uncertainties, trade show season has been kind to San Diego-based ResMed as the company continues to market its S9™ flow generators. The makers of the Swift and Mirage CPAP masks are spreading news of the S9‘s treatment technology in an attempt to create maximum value, an attribute that company officials say is even more important during uncertain times. “Our goal in the development of the S9 was to create a system that offers more than any other device on the market–more comfort, more control and more style–so users can feel confident about incorporating it into their lifestyle, and health care providers can be confident that their patients are receiving the highest quality of treatment,” said Terry.

Terry says the S9 represents a new approach to patient compliance, essentially making it easier for users to accept CPAP on their own terms. “It puts them in control of the details that make the difference in their personal comfort, like EPR™ level and humidification settings,” adds Terry. “It has intuitive menus and dials to make it easy to adjust. It reduces noise to a virtual whisper, so it won’t disrupt a sleeping partner. And it comes in a stylish design that looks like something they want to have at their bedside.”

With the S9 Series, ResMed has introduced a number of improvements, including Enhanced AutoSet™ and Easy-Breathe algorithms—and an improved Easy-Breathe motor for low noise levels. The S9 provides detailed data reporting for clinicians, and a complete S9-compatible wireless compliance management package to streamline business efficiencies. A humidification system with Climate Control intelligently adapts to the user’s real-time environmental conditions to provide optimum performance and humidification delivery. An innovative SlimLine™ tube eliminates tube drag.

Ultimately, the S9 is a large part of the overall push toward greater innovation in what will surely be a huge decade for sleep medicine. Companies big and small are all angling to serve the growing market, and Terry acknowledges that competition is fierce.

—————————————————————————————————–

Elizabeth Little is Product Manager Sleep, based with ResMed in San Diego, CA.

For more information, visit www.resmed.com

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Spotlight on Sensors Part 2

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Getting the Message

Braebon’s Don C. Bradley has seen a lot in his years in the sleep industry, but a subtle shift at the 2010 APSS signaled a new awareness that surprised the 20-year sleep veteran.

Previously, inquiries at Braebon’s APSS booth were noticeably more reserved in their enthusiasm about portable sleep monitoring. Don C. Bradley, the co-founder of Braebon Medical Corp, sensed the apprehension and compared it to dipping toes in the water. At the 24th annual APSS in San Antonio, attendees clearly knew the temperature of the water—and many decided to dive in. The subtle shift in sophistication and acceptance mirrors the industry’s continuing validation of ambulatory sleep monitoring. The shallow questions of the past have been replaced by serious inquiries. “The level of acceptance is noticeably greater than previous years,” says Bradley. “People want to get accurate data and results. They want to know how the software works and what is actually happening within the algorithms—as well as how easy is the device to use for patient and clinicians.”  
Separate measuring of oral and nasal pressure was a hot topic, as was the possibility of expanding capabilities to monitor the performance of the CPAP while it is attached to the patient within the patient’s own bedroom.

Better Sensors, Better Data
Braebon’s titration sensor accomplishes a further expansion of a sleep lab’s capabilities by allowing technicians to see flows, volumes, leaks, and actual pressures from any PAP device. Bradley educates attendees about this equipment, while also teaching technicians the finer points. “Knowing the tricks of using a sensor effectively is another important point,” explains Bradley. “At a recent event, we had several groups of technicians who were using our cannulae. They were concerned about occlusions inside the nose. One tip is to ask patients to blow their noses and clean out nostrils before they come to the lab. Maybe have them trim nose hairs so you don’t occlude. You can also trim the nasal prongs so they are actually perpendicular to the flow of air, and you get much more accurate signals.”

Focus on Snoring
As portable monitoring becomes ever more refined, Bradley maintains that focusing on overlooked details such as snoring can make a difference. Merely paying attention to these differences is often a foreign concept, but determining snores per hour is a good start.If you have the number of snores per hour, asks Bradley, then what about the effect in magnitude and volume/power? Knowing the actual change in volume when a patient undergoes therapy has merit, and it is one reason Braebon developed the Q-Snor, as well as placing this technology within the MediByte™ portable sleep screener (invented by Bradley and Richard A. Bonato, PhD, RPSGT, co-founder and CEO of Braebon Medical Corp, Ontario, Canada, to monitor the efficacy of oral appliance therapy).
qsnor braebon1 Spotlight on Sensors Part 2
Within the three main types of technologies used to determine snoring, technicians can access sensors that qualitatively measure vibrations on the neck—qualitative auditory signals or quantitative auditory signals. “The vibratory signal may contain artifacts such as cardiac pulses or head/body movements,” explains Bradley. “The qualitative or quantitative audio sensor may contain external artifacts such as talking. It is the quantitative audio sensor that can give us the most valuable information related to snoring in the patient. The quantitative audio sensor (Braebon Q-Snor) allows you to do a proper pre- and post-comparison of both snoring indices and change in overall volume in patients. This is paramount if one is to assess the effectiveness of certain types of therapies.”

Accurate Signals
Understanding sensor technology is paramount in ensuring the collection of accurate signals. As an example, piezo technology cannot measure events with low frequency content. At 10 HZ or higher, a piezo sensor responds acceptably well to what is going on. “If, however, you are looking to measure respiratory effort in patients with breathing rates of between 6 to 30 breaths per minute, and look for relative amplitude changes for each breath, a piezo sensor cannot give you what you need.” explains Bradley. “An accurate signal refers to not only the sensor’s ability to react quickly enough to the physiological event being measured, but to also output a signal that should be linearly proportional to the physiological event being measured.
“If I inhale and then exhale quickly, you won’t see the proper signal with a piezo based pressure sensor,” continues Bradley. “There will be a slow decay because of the filtering that has been added by the manufacturer to generate signals in the low frequency band that do not really exist. Properly developed sensors ensure that the sensor technology used generates an accurate signal. Some technologies are better than others. One must also consider the fact that just because a manufacturer states a type of technology is being used, it is not a guarantee that the sensor will accurately reproduce the physiological signal being measured. There are other factors that must be considered such as internal filtering of the raw signal before it even reaches the PSG amplifier system.”

Can You Trust Your Equipment?
Respected organizations such as the American Academy of Sleep Medicine () are always concerned with accuracy standards for things such as hypopneas. Bradley points out that the did in fact come out with guidelines on nasal hypopneas. Calling them “a great first stab,” he laments that the guidelines could only go so far since there has not yet been enough research to substantiate measuring oral pressure for indications of oral only events.

At the base of all sleep units, the question is essentially the same: Is what you see on the screen an accurate reflection of what is physiologically going on with patient? The recorded and displayed signals have meaning to the trained eye, but are they reliable? If you can’t trust your equipment, or know how to effectively use it, says Bradley, you have a fundamental problem. Sensors are the primary piece of equipment for obtaining signals and they must accurately reflect the physiological event being measured.
All sensors have limitations, and those limitations must be understood. Without proper understanding, you cannot expect to obtain accurate signals. The same type of sensor can use different technologies to give you a signal.
Accurately assessing the chest and abdominal effort of breathing is a basic function. When sensors are plugged into a PSG system, some technicians are simply hoping the filters and sampling rates are set right and that the sensor is working according to what they need. “The information comes up on the screen and you take that as gospel,” says Bradley, who in addition to his role as founder also serves as chief technology officer at Braebon. “But is that really what is happening? Is there effort happening on the chest and abdomen? One cannot answer that question without having a basic understanding of the technology involved.”
There are many technologies and methods for measuring airflow: pressure sensors; thermal sensors; and esophageal balloons to name three. Whatever method is used, Bradley contends that quality matters. “I could go out and buy the cheapest pressure sensor, and then I could buy a more expensive one,” says Bradley. “If you put a cannula on the patient and feed it simultaneously to both pressure sensors, you will see two totally different signals—yet people think if it is a pressure sensor, they are measuring accurately.”

Problems with Pressure
There are several different types of cannulae used to measure airflow to gauge the nasal and/or oral breathing component. “You’ve got the thermal side, so you can measure nasal and oral apneas because you’ve got a thermal sensor,” says Bradley. “However, you don’t have the oral component on the cannula, and that is something Braebon looked at and worked out. We have the PureFlow and PureFlow Duo cannulae. These cannulae have a big scoop designed to give you an accurate, almost 1:1 relationship between the nasal breathing and the oral breathing—as well as give you a reliable signal.

The PureFlow combines both the nasal and oral component into one signal whereas the PureFlow Duo, when working with the Braebon PT2 Dual Pressure Transducer, gives separate oral and nasal signals. This family of cannula allows users to look into oral breathing and be able to determine oral hypopneas or other phenomena that may be present in the oral signal and not in the nasal signal.

There are a lot of technical issues in trying to grab oral pressure and accurately represent it, because engineers are not dealing with an enclosed system. “You’ve got leaks everywhere as well as the changing shape of the oral orifice,” laments Bradley. “The nasal one is a little easier because you design prongs that go in and they act like pitot tubes so you can measure the pressures and infer airflow fairly accurately. Even though people have different diameters on their nose, there is not that much of a change. But the mouth really changes shape throughout the night plus, it has been shown, people change their breathing patterns throughout the night between nasal and oral. They have even had studies showing that the person will actually change their breathing between left and right nostrils throughout the night. It is almost like we are just getting into the science of these types of things and it is all coming down to how can we easily and accurately measure the amount of air moving in and out of the patient.”
medibyte braebon17 Spotlight on Sensors Part 2

The Future
If 2010 feels like a new awareness, what will the next decade bring? For Braebon, the long-term goals are part of a day-to-day strategy that builds on the fundamentals of meeting customers at trade shows and sleep laboratories. Spreading the message about MediByte and the MediByte Jr. is a top priority since the unit takes the company’s best sensor technology and essentially puts it in a compact device to record and store data. Deemed too far ahead of the curve in 2003, the locking connectors, simple software, and explanatory videos are all poised to properly outline the product for patients and clinicians.

For Bradley, optimism is easy to come by thanks to growing recognition that sleep is nothing less than an enormous part of overall health. “We spend a third of our life sleeping, and you need to know what is going on while in this state of slumber. I enjoy helping people and improving their quality of life. The industry has really grown and the best companies are lean, mean, and responsive—and have attributes that I have boiled down to the four Fs— Focused, Flexible, Friendly, and Fast.”

——————————————————————————————————————————————

Don Bradley is founder and chief technology officer for Braebon. He has worked in the sleep diagnostic industry for more than 19 years. He has designed and developed many medical devices including PSG systems and sleep sensors, authored several articles in technical and research publications, and given talks on technology in sleep.

For more information, visit www.braebon.com

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A Randomized, Double Blind, Placebo Controlled, Crossover Evaluation of Natural Frequency Technology™ and Sleep Natural Frequency Technology on Sleep in Normal Subjects with Un-refreshing Sleep

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Abstract:

Background: The purpose of this study was to test the impact of the Natural Frequency Technology (NFT) found in Philip Stein™ Watches (thought to promote overall well-being) and Sleep NFT, (a combination of frequencies designed to promote sleep) on sleep parameters in normal healthy individuals who routinely experience un-refreshing sleep. NFT is a sub 8Hz combination of frequencies that are imprinted on a metal disk placed in a watch worn by the sleeper. Sleep NFT is also a combination of sub 8Hz frequencies,  but different from the  combination of frequencies used in NFT.

Methods:
Subjects: Females (20) and males (8) with an average age of 37.7 years and average BMI of 26.5. Subjects underwent two consecutive nights in the sleep laboratory for each of the conditions (Placebo, /Placebo; NFT/Placebo; NFT/SleepNFT). There was a 5-7 day washout period between sessions. This was a double blind experiment. Subjects arrived two hours before habitual bedtime. They went to sleep at their habitual bedtime and stayed in bed until they woke the next morning (or 8 hours whichever came first). Upon awakening, subjects were asked to complete questionnaires (including  Epworth, Sleep Quality Questionnaire, Clinical Global Impressions of Change) asking them about each of the following variables: Total Sleep Time, Sleep Onset Latency, Minutes Awake in the Middle of the Night, Perception of Refreshment, Epworth Sleepiness Scale, and Dream Quality . Vital signs were taken upon awakening and before sleep during all conditions.

Results: Data analysis was performed using a repeated measures ANOVA and Bonferoni t-tests for post hoc analysis.  There was not a statistically significant difference noted when comparing overall response between conditions; however, 96% of the subjects responded to at least one of the variables during the NFT conditions. The results of those responders indicate: 43% of responders reported feeling more refreshed, 52% reported dreaming was more pleasant, 47% reported falling asleep faster, 39% reported sleeping more minutes, and 36% reported fewer minutes awake when using NFT than placebo. During the NFT/Sleep NFT condition the results of those responders indicate: 64% report feeling more refreshed, 61% report that dreaming was more pleasant, 43% report falling asleep faster, 43% reported sleeping more total minutes, while only 18% reported fewer minutes awake.
Conclusion: While the current overall results are not statistically significant, a substantial number of subjects demonstrated response to NFT or SleepNFT and reported improvements in the measured  individual sleep parameters. Feeling more refreshed after sleep was the primary outcome measure that most clearly separated from placebo. Future studies to determine clinical effectiveness of NFT and Sleep NFT  are suggested in the home environment.

Correspondence to: Michael J. Breus, PhD President Mindworks, 11445 E. Via Linda, Suite 2491, Scottsdale AZ 85259. Support: Support for this study was provided by Philip Stein, Inc.

Introduction: Most electromagnetic fields (EMF) appear to have some effect on biologic life. In recent years several EMFs have been found to help support better health (Crasson, 2003). It has been hypothesized that some of the natural frequencies generated by the earth (e.g., the Schumann Resonance 7.83 Hz) have been affecting humans since the beginning of time (Polk, 1986).  The Schumann Resonance in particular appears to produce positive effects on humans at lower intensities (Crasson, 2003). Since the human body also produces frequencies, it also has been shown that these body frequency generators can be “tuned” or entrained to an external influential EMF (Cherry, 2003). Examples of this process have been effective therapeutic tools for decades, e.g., biofeedback leading to relaxation. The most beneficial frequencies for health appear to be extremely low frequencies (ELF), less than 100Hz. Siskin and Walker show the healing effects of several frequencies in their 1995 paper (Siskin, 1995):

Table 1 704 A Randomized, Double Blind, Placebo Controlled, Crossover Evaluation of Natural Frequency Technology™ and Sleep Natural Frequency Technology on Sleep in Normal Subjects with Un refreshing Sleep

The purposeful application of these frequencies to the body to develop a healing response has been named “bioelectromagnetic medicine” (Rubik, 1997).  Applications have been studied and found efficacious for Parkinson’s Disease (Sandyk, 1993) and bone fractures (Sharrard, 1990).
Sleep itself is defined by wave forms, many of which also lie at the ELF range. EEG signals recorded for sleep include delta waves (1-4 Hz), theta waves (6-10 Hz), alpha (8-12 Hz), and beta at (12-30 Hz). These EEG signals by definition are being generated by structures within the brain (Thalamus) and influencing other processes within the brain (neurotransmission). The question then becomes can the brain, and more specifically, sleep, be influenced by external ELF. Before a full pilot study for sleep was to be conducted, a preliminary study was performed to see if the ELF combinations found in Philip Stein™ watches could have an effect on the body by studying the effects of ELFs on heart rate.

Preliminary Pilot Study
In a preliminary pilot study with ten subjects conducted by Dr. Beverly Rubik at an independent laboratory (Rubik, 2009),  the effect of ELFs ( including a 7.83 Hz imprinted into the Philip Stein™ watch) on heart rate variability (HRV) was measured.  HRV refers to the variable time between heartbeats.   Higher levels of HRV indicate greater resilience and adaptability to stress.  Lower values are associated with reduced adaptability to stress and change.  Typically HRV also decreases with age. In this study the measurements were taken in a laboratory setting for each subject in individual sessions under three conditions, during which they were seated and resting comfortably:  (1) before wearing the watch, (2) five minutes afterward, and (3) one hour later.  Nine out of ten subjects showed positive changes in HRV.  HRV increased 32.6% for all subjects at one hour, from 42.6 to 56.6 milliseconds, on average.  The increase at five minutes was not as strong, 7.4% for all subjects, from 42.6 to 45.8 milliseconds, on average, so it appears that length of time of exposure to the ELF may be a factor.  These positive results on HRV with associated improvements in autonomic nervous system balance suggest increased relaxation is associated with exposure to the Natural Frequency Technology in the Philip Stein watch™.

Preliminary Pilot Study Conclusions: Exposure to the ELF appears to produce an increase in HRV after one hour. Based on the results of the preliminary pilot study  of the effect of ELF on HRV, it was proposed that the ELFs in the Philip Stein™ watch should have some effect on sleep, due to the apparent effect observed on the autonomic nervous system. With an increase in HRV, there was  a noted decrease in stress. Since stress has been shown to induce poor sleep, an exploratory study was designed to determine if the positive effect of ELF on stress would have also have an effect on sleep.

The Sleep Study
The purpose of this study was to test the impact of the Natural Frequency Technology (NFT)™ found in Philip Stein™ watches and the NFT Technology (comprised of different ELFs) (Sleep NFT) found in a separate “Sleep Bracelet” on sleep parameters in normal, healthy individuals who routinely experience un-refreshing sleep.

The Devices: Participants received two identical bracelets with polished stainless steel cases. There were two available active bracelets and one placebo bracelet.  Within the NFT  active bracelet cases were two NFT™ stainless steel disks with embedded frequencies;, within the Sleep NFT  active bracelet cases  were two Sleep NFT stainless steel disks (with a different combination of frequencies). The frequencies ranged from slightly above 0 Hz to no more than 8Hz. One of the key frequencies was 7.83 (The Schumann Resonant Frequency). The placebo bracelet had the same disks without any embedded frequencies.

Figure 1 2721 A Randomized, Double Blind, Placebo Controlled, Crossover Evaluation of Natural Frequency Technology™ and Sleep Natural Frequency Technology on Sleep in Normal Subjects with Un refreshing Sleep


Methods: Prospective participants were screened at Visit 1 where vital signs were collected with a urine drug screen. If they met none of the exclusion criteria they returned for Visit 2 approximately five days later. Visits 2 , 3 and 4 each consisted of one visit to the office (in the morning) and two overnight stays at the sleep lab.  At each visit, the subjects went to the office the morning of the first overnight stay to be dispensed a bracelet (placebo or NFT determined by randomized counterbalanced schedule) by an un-blinded staff member. The un-blinded staff member did not perform any procedures on subjects. The subjects returned to the office that evening for an overnight stay at the sleep lab.  The subjects were required to wear the bracelet given to them that morning for a minimum of ten hours prior to lights out. Lights out occurred plus/minus one hour from the subject’s habitual bedtime.  Upon arrival for the overnight stay, a urine drug screen and breathalyzer was performed. Vital signs (heart rate, blood pressure and pulse) were collected. The subject was then issued a second bracelet (placebo or NFT Sleep) in a counterbalanced random order. Total time in bed was equal to eight hours.  After eight hours in bed the subject was awakened, if not already awake.  Thirty minutes after awakening a Sleep Quality Questionnaire (SQQ) was completed by the subject. Vital signs were collected each morning. The bracelet issued the night before was removed, and the subject was reminded to continue wearing the bracelet issued at the prior morning’s visit all day and to arrive at the sleep lab in the evening for the second night. When the subject arrived for the second night, the same procedures as the previous night were conducted and the subject was re-issued the same second bracelet as the previous night.  The morning after the second night, the subject completed the SQQ, the Epworth Sleepiness Scale, vitals were collected and the study staff completed the Clinical Global Impression of Change Questionnaire. The subjects then had both of the bracelets removed, and returned for the third visit between five and seven days later (washout period),  Visit 3 repeated the same two day procedure as described for Visit 2 in a counterbalanced manner.   Visit 4  was scheduled  between five and seven days after Visit 3 (washout period), and again repeated the same two procedure as described for Visit 2.  The protocol underwent full review and approval by an IRB.

Subject inclusion criteria: general good health, must self report un-refreshing sleep for at least the past 3 months, and no current sleep disorder. Un-refreshing sleep was defined as a nightly total sleep time of <6 hours, a sleep onset latency of >30 min, a WASO of >30 minutes, and an Epworth Sleepiness Scale Score of > 10.
Subject Demographics: Twenty females and eight males completed the study. Average age was 37.7 years and average Body Mass Index (BMI) was 25.4 for females and 27.5 for males.

Results: Data analysis was performed using a repeated measures ANOVA and Bonferoni t-tests for post hoc analysis.  For each subject, data for the two night stay in the laboratory was combined and averaged. There were no statistically significant differences noted when comparing the conditions. The conditions (placebo/NFT;  placebo/SleepNFT; NFT/SleepNFT). However, 96% of all subjects responded to at least one variable, and the results of those responders indicate:

·    43% of responders reported feeling more refreshed when using the NFT than using placebo
o    64% reported feeling more refreshed when wearing both the NFT and Sleep NFT than placebo.
·    52% reported dreaming was more pleasant when using the NFT than placebo
o    61% reported dreaming was more pleasant when using both the NFT and Sleep NFT than placebo.
·    47% reported falling asleep faster when using the NFT than placebo
o    43% reported falling asleep faster when using both the NFT and  SleepNFT than placebo
o    The largest reduction was an improvement of 32 minutes.
·    39% reported sleeping more total minutes when using the NFT than placebo
o    43% reported sleeping more total minutes when using both the NFT and SleepNFT  than placebo.
o    The largest improvement was an increase of 65 minutes.
·    36% reported fewer minutes awake when using the NFT than placebo.
o    18% reported fewer minutes awake when using both the NFT and SleepNFT  than placebo.
o    The largest improvement was a decrease of 22 minutes.

Conclusion: While the current overall results are not statistically significant, a substantial number of subjects demonstrated improvements in the measured individual sleep parameters. Feeling more refreshed after sleep was the primary outcome measure that most clearly separated from placebo.  There was not a clear indication that the combination of devices was better than the single device alone condition across all of the sleep parameters. A direct comparison of devices was not conducted in this study. Factors effecting the overall statistical significance of these results could have been environmental (a first night effect), subject inclusion or exclusion criteria, or a placebo effect. Results of this pilot study suggest future studies to determine clinical effectiveness of NFT and SleepNFT should be conducted.

References
Crasson, M (2003) 50-60Hz electric and magnetic field effects on cognitive function in humans: a review. Radiat Prot Dosimetry. 106 (4): 333-40.

Cherry, NJ. Human Intelligence: the brain, an electromagnetic system synchronized by the Schumann Resonance signal. Med Hypotheses, (2003), Jun 60 (6): 843-844.

Polk, C; Postow, E. eds. CRC Handbook of Biological Effects of Electromagnetic Fields. Boca Raton, FL; CRC Press, (1986).

Siskin, B F, Walker J. Theraputic aspects of electromagnetic fields for soft-tissue healing. In Blank M ed. Electromagnetic fields: Biological interactions and Mechanisms. Advances in Chemistry Series 250. Washington, DC: American Chemical Society, (1995): 277-285.

Rubik, B. Bioelectromagnetic medicine. Admin Radiol J (1997a); XVI: 38-46.

Sandyk, R, Derpapas K. Further observations on the unique efficacy of picoTesla range magnetic magnetic fields in Parkinson’s Disease. Int J Neuroscience, (1993); 69, 167-183.

Sharrard, WJW. A double blind trial of pulsed electromagnetic fields for delayed union of tibial fractures. J Bone Joint Surg (Br) (1990); 72B; 347-355.

Rubik, B. (2009) Exploratory Study on the Beneficial Effects of Wearing Philip Stein Frequency Timepieces.  (Unpublished manuscript). Institute for Frontier Science; Oakland, CA 94611

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A Randomized, Double Blind, Placebo Controlled, Crossover Evaluation of Natural Frequency Technology™ and Sleep Natural Frequency Technology on Sleep in Normal Subjects with Un-refreshing Sleep

Leave a comment

Abstract:

Background: The purpose of this study was to test the impact of the Natural Frequency Technology (NFT) found in Philip Stein™ Watches (thought to promote overall well-being) and Sleep NFT, (a combination of frequencies designed to promote sleep) on sleep parameters in normal healthy individuals who routinely experience un-refreshing sleep. NFT is a sub 8Hz combination of frequencies that are imprinted on a metal disk placed in a watch worn by the sleeper. Sleep NFT is also a combination of sub 8Hz frequencies,  but different from the  combination of frequencies used in NFT.

Methods:
Subjects: Females (20) and males (8) with an average age of 37.7 years and average BMI of 26.5. Subjects underwent two consecutive nights in the sleep laboratory for each of the conditions (Placebo, /Placebo; NFT/Placebo; NFT/SleepNFT). There was a 5-7 day washout period between sessions. This was a double blind experiment. Subjects arrived two hours before habitual bedtime. They went to sleep at their habitual bedtime and stayed in bed until they woke the next morning (or 8 hours whichever came first). Upon awakening, subjects were asked to complete questionnaires (including  Epworth, Sleep Quality Questionnaire, Clinical Global Impressions of Change) asking them about each of the following variables: Total Sleep Time, Sleep Onset Latency, Minutes Awake in the Middle of the Night, Perception of Refreshment, Epworth Sleepiness Scale, and Dream Quality . Vital signs were taken upon awakening and before sleep during all conditions.

Results: Data analysis was performed using a repeated measures ANOVA and Bonferoni t-tests for post hoc analysis.  There was not a statistically significant difference noted when comparing overall response between conditions; however, 96% of the subjects responded to at least one of the variables during the NFT conditions. The results of those responders indicate: 43% of responders reported feeling more refreshed, 52% reported dreaming was more pleasant, 47% reported falling asleep faster, 39% reported sleeping more minutes, and 36% reported fewer minutes awake when using NFT than placebo. During the NFT/Sleep NFT condition the results of those responders indicate: 64% report feeling more refreshed, 61% report that dreaming was more pleasant, 43% report falling asleep faster, 43% reported sleeping more total minutes, while only 18% reported fewer minutes awake.

Conclusion: While the current overall results are not statistically significant, a substantial number of subjects demonstrated response to NFT or SleepNFT and reported improvements in the measured  individual sleep parameters. Feeling more refreshed after sleep was the primary outcome measure that most clearly separated from placebo. Future studies to determine clinical effectiveness of NFT and Sleep NFT  are suggested in the home environment.

Correspondence to: Michael J. Breus, PhD President Mindworks, 11445 E. Via Linda, Suite 2491, Scottsdale AZ 85259. Support: Support for this study was provided by Philip Stein, Inc.

Introduction: Most electromagnetic fields (EMF) appear to have some effect on biologic life. In recent years several EMFs have been found to help support better health (Crasson, 2003). It has been hypothesized that some of the natural frequencies generated by the earth (e.g., the Schumann Resonance 7.83 Hz) have been affecting humans since the beginning of time (Polk, 1986).  The Schumann Resonance in particular appears to produce positive effects on humans at lower intensities (Crasson, 2003). Since the human body also produces frequencies, it also has been shown that these body frequency generators can be “tuned” or entrained to an external influential EMF (Cherry, 2003). Examples of this process have been effective therapeutic tools for decades, e.g., biofeedback leading to relaxation. The most beneficial frequencies for health appear to be extremely low frequencies (ELF), less than 100Hz. Siskin and Walker show the healing effects of several frequencies in their 1995 paper (Siskin, 1995):


The purposeful application of these frequencies to the body to develop a healing response has been named “bioelectromagnetic medicine” (Rubik, 1997).  Applications have been studied and found efficacious for Parkinson’s Disease (Sandyk, 1993) and bone fractures (Sharrard, 1990).
Sleep itself is defined by wave forms, many of which also lie at the ELF range. EEG signals recorded for sleep include delta waves (1-4 Hz), theta waves (6-10 Hz), alpha (8-12 Hz), and beta at (12-30 Hz). These EEG signals by definition are being generated by structures within the brain (Thalamus) and influencing other processes within the brain (neurotransmission). The question then becomes can the brain, and more specifically, sleep, be influenced by external ELF. Before a full pilot study for sleep was to be conducted, a preliminary study was performed to see if the ELF combinations found in Philip Stein™ watches could have an effect on the body by studying the effects of ELFs on heart rate.

Preliminary Pilot Study
In a preliminary pilot study with ten subjects conducted by Dr. Beverly Rubik at an independent laboratory (Rubik, 2009),  the effect of ELFs ( including a 7.83 Hz imprinted into the Philip Stein™ watch) on heart rate variability (HRV) was measured.  HRV refers to the variable time between heartbeats.   Higher levels of HRV indicate greater resilience and adaptability to stress.  Lower values are associated with reduced adaptability to stress and change.  Typically HRV also decreases with age. In this study the measurements were taken in a laboratory setting for each subject in individual sessions under three conditions, during which they were seated and resting comfortably:  (1) before wearing the watch, (2) five minutes afterward, and (3) one hour later.  Nine out of ten subjects showed positive changes in HRV.  HRV increased 32.6% for all subjects at one hour, from 42.6 to 56.6 milliseconds, on average.  The increase at five minutes was not as strong, 7.4% for all subjects, from 42.6 to 45.8 milliseconds, on average, so it appears that length of time of exposure to the ELF may be a factor.  These positive results on HRV with associated improvements in autonomic nervous system balance suggest increased relaxation is associated with exposure to the Natural Frequency Technology in the Philip Stein watch™.

Preliminary Pilot Study Conclusions: Exposure to the ELF appears to produce an increase in HRV after one hour. Based on the results of the preliminary pilot study  of the effect of ELF on HRV, it was proposed that the ELFs in the Philip Stein™ watch should have some effect on sleep, due to the apparent effect observed on the autonomic nervous system. With an increase in HRV, there was  a noted decrease in stress. Since stress has been shown to induce poor sleep, an exploratory study was designed to determine if the positive effect of ELF on stress would have also have an effect on sleep.

The Sleep Study
The purpose of this study was to test the impact of the Natural Frequency Technology (NFT)™ found in Philip Stein™ watches and the NFT Technology (comprised of different ELFs) (Sleep NFT) found in a separate “Sleep Bracelet” on sleep parameters in normal, healthy individuals who routinely experience un-refreshing sleep.

The Devices: Participants received two identical bracelets with polished stainless steel cases. There were two available active bracelets and one placebo bracelet.  Within the NFT  active bracelet cases were two NFT™ stainless steel disks with embedded frequencies;, within the Sleep NFT  active bracelet cases  were two Sleep NFT stainless steel disks (with a different combination of frequencies). The frequencies ranged from slightly above 0 Hz to no more than 8Hz. One of the key frequencies was 7.83 (The Schumann Resonant Frequency). The placebo bracelet had the same disks without any embedded frequencies.

Methods: Prospective participants were screened at Visit 1 where vital signs were collected with a urine drug screen. If they met none of the exclusion criteria they returned for Visit 2 approximately five days later. Visits 2 , 3 and 4 each consisted of one visit to the office (in the morning) and two overnight stays at the sleep lab.  At each visit, the subjects went to the office the morning of the first overnight stay to be dispensed a bracelet (placebo or NFT determined by randomized counterbalanced schedule) by an un-blinded staff member. The un-blinded staff member did not perform any procedures on subjects. The subjects returned to the office that evening for an overnight stay at the sleep lab.  The subjects were required to wear the bracelet given to them that morning for a minimum of ten hours prior to lights out. Lights out occurred plus/minus one hour from the subject’s habitual bedtime.  Upon arrival for the overnight stay, a urine drug screen and breathalyzer was performed. Vital signs (heart rate, blood pressure and pulse) were collected. The subject was then issued a second bracelet (placebo or NFT Sleep) in a counterbalanced random order. Total time in bed was equal to eight hours.  After eight hours in bed the subject was awakened, if not already awake.  Thirty minutes after awakening a Sleep Quality Questionnaire (SQQ) was completed by the subject. Vital signs were collected each morning. The bracelet issued the night before was removed, and the subject was reminded to continue wearing the bracelet issued at the prior morning’s visit all day and to arrive at the sleep lab in the evening for the second night. When the subject arrived for the second night, the same procedures as the previous night were conducted and the subject was re-issued the same second bracelet as the previous night.  The morning after the second night, the subject completed the SQQ, the Epworth Sleepiness Scale, vitals were collected and the study staff completed the Clinical Global Impression of Change Questionnaire. The subjects then had both of the bracelets removed, and returned for the third visit between five and seven days later (washout period),  Visit 3 repeated the same two day procedure as described for Visit 2 in a counterbalanced manner.   Visit 4  was scheduled  between five and seven days after Visit 3 (washout period), and again repeated the same two procedure as described for Visit 2.  The protocol underwent full review and approval by an IRB.

Subject inclusion criteria: general good health, must self report un-refreshing sleep for at least the past 3 months, and no current sleep disorder. Un-refreshing sleep was defined as a nightly total sleep time of <6 hours, a sleep onset latency of >30 min, a WASO of >30 minutes, and an Epworth Sleepiness Scale Score of > 10.

Subject Demographics: Twenty females and eight males completed the study. Average age was 37.7 years and average Body Mass Index (BMI) was 25.4 for females and 27.5 for males.

Results: Data analysis was performed using a repeated measures ANOVA and Bonferoni t-tests for post hoc analysis.  For each subject, data for the two night stay in the laboratory was combined and averaged. There were no statistically significant differences noted when comparing the conditions. The conditions (placebo/NFT;  placebo/SleepNFT; NFT/SleepNFT). However, 96% of all subjects responded to at least one variable, and the results of those responders indicate:
·    43% of responders reported feeling more refreshed when using the NFT than using placebo
o    64% reported feeling more refreshed when wearing both the NFT and Sleep NFT than placebo.
·    52% reported dreaming was more pleasant when using the NFT than placebo
o    61% reported dreaming was more pleasant when using both the NFT and Sleep NFT than placebo.
·    47% reported falling asleep faster when using the NFT than placebo
o    43% reported falling asleep faster when using both the NFT and  SleepNFT than placebo
o    The largest reduction was an improvement of 32 minutes.
·    39% reported sleeping more total minutes when using the NFT than placebo
o    43% reported sleeping more total minutes when using both the NFT and SleepNFT  than placebo.
o    The largest improvement was an increase of 65 minutes.
·    36% reported fewer minutes awake when using the NFT than placebo.
o    18% reported fewer minutes awake when using both the NFT and SleepNFT  than placebo.
o    The largest improvement was a decrease of 22 minutes.

Conclusion: While the current overall results are not statistically significant, a substantial number of subjects demonstrated improvements in the measured individual sleep parameters. Feeling more refreshed after sleep was the primary outcome measure that most clearly separated from placebo.  There was not a clear indication that the combination of devices was better than the single device alone condition across all of the sleep parameters. A direct comparison of devices was not conducted in this study. Factors effecting the overall statistical significance of these results could have been environmental (a first night effect), subject inclusion or exclusion criteria, or a placebo effect. Results of this pilot study suggest future studies to determine clinical effectiveness of NFT and SleepNFT should be conducted.

References

Crasson, M (2003) 50-60Hz electric and magnetic field effects on cognitive function in humans: a review. Radiat Prot Dosimetry. 106 (4): 333-40.

Cherry, NJ. Human Intelligence: the brain, an electromagnetic system synchronized by the Schumann Resonance signal. Med Hypotheses, (2003), Jun 60 (6): 843-844.

Polk, C; Postow, E. eds. CRC Handbook of Biological Effects of Electromagnetic Fields. Boca Raton, FL; CRC Press, (1986).

Siskin, B F, Walker J. Theraputic aspects of electromagnetic fields for soft-tissue healing. In Blank M ed. Electromagnetic fields: Biological interactions and Mechanisms. Advances in Chemistry Series 250. Washington, DC: American Chemical Society, (1995): 277-285.

Rubik, B. Bioelectromagnetic medicine. Admin Radiol J (1997a); XVI: 38-46.

Sandyk, R, Derpapas K. Further observations on the unique efficacy of picoTesla range magnetic magnetic fields in
Parkinson’s Disease. Int J Neuroscience, (1993); 69, 167-183.

Sharrard, WJW. A double blind trial of pulsed electromagnetic fields for delayed union of tibial fractures. J Bone Joint Surg (Br) (1990); 72B; 347-355.

Rubik, B. (2009) Exploratory Study on the Beneficial Effects of Wearing Philip Stein Frequency Timepieces.  (Unpublished manuscript). Institute for Frontier Science; Oakland, CA 94611.

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