By: Jim McMahon
Widely recognized evidence supports the fact that Obstructive Sleep Apnea is a very serious health risk primarily afflicting men over the age of forty, yet 80 to 90 percent of cases go undiagnosed except for the telltale symptoms of chronic fatigue and snoring. Precision diagnosis and recent developments in FDA-approved mouthpiece technology can now provide an unprecedented 78 percent reduction of the condition without surgery, and offer for the first time an effective and convenient alternative for those intolerant to using the frequently prescribed but highly rejected Continuous Positive Airway Pressure therapy.
Next time you are traveling on an air flight and are annoyed by the guy sleeping next to you who is snoring, realize that there could be much more behind that than just an irritating sound, this person could have Obstructive Sleep Apnea. Apnea is a Greek word that means ‘not breathing’. Obstructive Sleep Apnea (OSA) is a condition caused by the tongue falling back and blocking the airway for anywhere between 10 and 90 seconds while someone is sleeping. This creates breathing pauses where the person is not getting oxygen. In OSA, these episodes occur from 15 to as many as 100 times each hour. This deprives one of the sleep and oxygen required to function normally and presents a dangerous detriment to a person’s long-term health.
According to the National Institutes of Health, an agency of the U.S. Department of Health and Human Services, more than 12 million Americans have Obstructive Sleep Apnea – these being predominantly male, overweight and over the age of forty. Yet, 80 to 90 percent of adults with the condition remain undiagnosed, says the American Academy of Sleep Medicine.
Such was the case with David Friedman, a 51 year-old owner of a high-end jewelry store in Westwood Village, California. “My wife couldn’t sleep because my snoring was rattling the walls,” says Friedman. “If I wasn’t snoring she was frightened because it meant that I wasn’t breathing.”
A diagnostic sleep study conducted on David at the UCLA Sleep Disorders Laboratory in Santa Monica, California confirmed that David indeed did have a severe case of Obstructive Sleep Apnea. “Before the sleep test, the doctor told me that if I had more than ten episodes of breathing pauses an hour I would require treatment for OSA,” explains Friedman. “After 30 minutes, they stopped counting.”
Snoring does not mean someone has Obstructive Sleep Apnea, but snoring occurs with most people that suffer from it. Fifty-two percent of all Americans over the age of 40 snore, says Dr. Meir H. Kryger, author of Principles and Practice of Sleep Medicine, published in 2005.
A National Sleep Foundation survey, also conducted in 2005, found that 23 percent of couples sleep in separate beds, separate bedrooms or one of them on the couch because of a mate’s sleep problems. Many people snore, but loud, habitual snoring may signal the much more serious disorder of Obstructive Sleep Apnea.
Widely recognized evidence supports the fact that Obstructive Sleep Apnea is an extremely serious health risk. The American Sleep Apnea Association says that untreated, OSA can cause high blood pressure and other cardiovascular disease, memory problems, weight gain, impotency and headaches.
The American Thoracic Society reported at its 2007 International Conference that researchers at the Yale University School of Medicine found patients with Obstructive Sleep Apnea are at increased risk for developing Type 2 diabetes. The researchers also found evidence that sleep apnea is associated with hypertension, stroke and heart disease.
Similarly, the U.S. Department of Health and Human Services stated in its June, 2008 National Guidelines, “OSA is a significant risk factor for the development of hypertension, and has been associated with Type 2 diabetes, coronary artery disease and may lead to significant impairments in quality of life.” It further says, “Untreated sleep apnea will mimic or exacerbate depression, ADHD, and other chronic disorders.”, and that “A significant percentage of the general adult population is at risk for OSA.”
Further supporting the implications of OSA was a study funded by the National Institutes of Health and published in the August, 2008 issue of the journal Sleep, the official publication of the American Academy of Sleep Medicine (AASM). This study states that an increased risk of high blood pressure, cardiovascular disease, stroke and diabetes may play a role in the association between Obstructive Sleep Apnea and mortality. In fact, the journal stated that persons with severe OSA have a 300 percent greater risk of dying, from any cause, than those who do not suffer from this condition.
After studying the sleep characteristics of nearly 11,000 adults in an overnight sleep laboratory, in November, 2008 Mayo Clinic researchers suggested that obstructive sleep apnea (OSA) – and, in particular, the low nighttime oxygen saturation of the blood it causes – may be a risk factor for sudden cardiac death. The American Heart Association describes sudden cardiac death as “resulting from an abrupt loss of heart function. The victim may or may not have diagnosed heart disease. The time and mode of death are unexpected. It occurs within minutes after symptoms appear.”
The Cause of OSA and Snoring
For years there was speculation as to what caused OSA and snoring. There were theories that it was caused by enlarged uvulas, oversized tonsils and adenoids, swollen tissues, sinus inflammation, deviated septums and airway tissue fat.
More recently, it was found that when one enters the deeper levels of sleep needed to rest and heal the body, the tongue can roll back covering the airway completely and interrupting breathing as with Obstructive Sleep Apnea, or partially block the airway causing the soft palate to vibrate creating the sound of snoring.
A healthy individual enters the deep levels of sleep, referred to as REM (Rapid Eye Movement) sleep, at various times throughout the night. REM is where dreaming, body repair and rejuvenation occur. For these functions to take place, the body apparently shuts down other bodily systems, causing the muscles of the body, including the tongue, to relax.
Most Sleep Apnea patients suffer because of the lack of REM sleep. “I would fall asleep all of the time,” continues Friedman. “I could barely keep my eyes open during the day.”
Determining if You Have OSA
While snoring indicates some level of a sleeping disorder, there is only one way to determine with certainty if someone has Obstructive Sleep Apnea. This is with a test that is performed in a hospital-administered sleep lab or sleep center, called a PolySomnoGraph (PSG). It is an elaborate test that measures valuable data about the quality of sleep a person is getting.
There are three critical PSG measurements that are used most often to diagnose and measure Obstructive Sleep Apnea: 1) the amount of airway blockage, called the AHI (Apnea Hypopnea Index). An index used to assess the severity of Sleep Apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep; 2) the amount of deep sleep achieved, an REM sleep percentage; and 3) the amount of oxygenation percentage during sleep.
The results of this test are studied by a medical doctor who then makes a diagnosis and a recommendation for treating the person.
Advances in Treatment
Weight is the single biggest factor associated with Sleep Apnea, and weight loss is one of the most recommended solutions for treating the problem. When one is overweight, the tongue does not need to fall as far back to partially or fully block the airway. When weight loss occurs, it lessens the potentiality of blockage.
Surgery is sometimes recommended, but has mixed results with solving the problem, and few procedures address the tongue, which is the source of OSA. But even when the tongue is addressed with surgery, the success rate is frequently no more than a 50/50 improvement of the OSA condition.
“I had a significant snoring issue,” says Barry Gold, a 61 year-old litigation attorney and principal in a Los Angeles-based law firm. “I had the Sleep Apnea testing done, and the sleep interruption episodes were substantial. My ear, nose and throat doctor recommended that I have surgery to the back of my tongue in an attempt to correct the Obstructive Sleep Apnea problem.”
“One surgery was done, and then a second,” explains Gold. “But they did nothing to change my OSA or snoring”.
Those with severe Obstructive Sleep Apnea have typically relied upon the use of a CPAP (continuous positive airway pressure) machine, the most prescribed treatment for OSA. It employs a mask which fits over the person’s nose and mouth during sleep and blows high-pressured air into the mouth, or up the nose, to open the airway. It is a successful treatment when used, but many find it very uncomfortable – resulting in the CPAP being rejected by 50 to 75 percent of persons who have tried it. For people who are afflicted with Obstructive Sleep Apnea, yet cannot tolerate using the CPAP, this presents a significant problem.
“I tried CPAP for about six months, two different devices, and they didn’t work for me,” Gold says. “The machines made noise. If I moved around, the air hose would slip out of my mouth and make even more noise, and I would wake up. It was really unsatisfactory. The whole benefit of CPAP was lost for me.”
Carl Rydlund, a 43 year-old musician, also knows what it is like to suffer from severe OSA and be unable to tolerate a CPAP machine. “I tried the CPAP machine for a good six months and it was a constant battle,” says Rydlund. “Almost every night I would knock the facemask off in my sleep, and the breathing lapses and snoring would continue. I wasn’t getting any more sleep with the CPAP than before without it.”
As an alternative for CPAP-intolerant persons, the U.S. Department of Health and Human Services has, within the past several years, recommended the use of oral mouthpieces for the treatment of OSA. “CPAP treatment may cause side effects in some people. These side effects include a dry or stuffy nose, irritated skin on your face, sore eyes, and headaches. If your CPAP isn’t properly adjusted, you may get stomach bloating and discomfort while wearing the mask.” For many patients that are CPAP-intolerant, an oral device may be their only solution.
Additionally, the Department states, “Oral appliances are a recommended treatment for patients with mild OSA who have not responded to lifestyle modification (weight loss).”
It goes on to say, “A dentist or orthodontist can make a custom-fit plastic mouthpiece for treating sleep apnea. The mouthpiece will adjust your lower jaw and your tongue to help keep your airways open while you sleep.”
This recognition by the U.S. Department of Health and Human Services, along with other recommendations from the American Academy of Sleep Medicine, and the American Academy of Dental Sleep Medicine, have opened the door to the use of oral mouthpieces administered through dental practitioners for the treatment of OSA and snoring.
For the most part, the dental mouthpieces that are available obtain their success by advancing the jaw forward. The tongue is thus pulled forward and the airway is opened. Many of these oral appliances, however, have proven to be uncomfortable to use and cause jaw pain.
But recent and significant improvements have been made in the design of some oral appliances to make them not only more comfortable, but more effective in reducing the incidence of OSA episodes and snoring.
The most effective of these devices, according to FDA testing and dental peer review, is the Full Breath Solution®. Having received its fifth FDA certification in 2009 (more than any other mouthpiece used for Sleep Apnea or snoring) and two patents, the device is the most successful oral sleep mouthpiece in use. It presents a very different approach to treatment.
“Rather than pulling the tongue forward by advancing the jaw, the Full Breath Solution works by utilizing a tail that restrains the tongue from moving upward and backward,” says Dr. Bryan Keropian, D.D.S., inventor of the Full Breath Solution and founder of the
Center for Snoring & CPAP Intolerance which provides non-surgical treatment for patients who are CPAP-intolerant. “The tail lightly depresses the tongue and prevents its movement backward, keeping the airway unblocked. The length of the tail is custom-fitted to each person, using advanced 3D dental imaging for precise diagnostics to ensure the most comfortable and effective placement.”
Dentistry Today, the leading peer-reviewed journal for dentists, published a feature story in its November, 2009 issue on the efficacy of dental mouthpieces for controlling Obstructive Sleep Apnea and snoring, where it states… “The Full Breath Solution sleep appliance differs from other sleep appliances in that it has a posterior tongue restrainer (tail). This controls and restrains the tongue in a manner that could not be previously achieved. In addition, utilizing 3D imaging allows the dentist to view treatment progress and to make the appropriate changes to ensure clinical success. Utilizing these advanced oral and imaging techniques, dentistry can now realize success in treating snoring and OSA patients, far beyond the low tolerance rates of CPAP, and well beyond the hit-and-miss success rate of other oral appliance (mouthpieces) techniques.”
For the first time OSA and snoring-plagued individuals are achieving a consistent 78.9 percent reduction in OSA events, as acknowledged by the FDA in the Full Breath mouthpiece’s latest 2009 certification. Additionally, 95 percent of patients have shown an elimination of snoring.
“A few years ago I was introduced to the Full Breath mouthpiece, and for the first time there was a noticeable reduction in my snoring and disruption of sleep,” says Gold. “It was measurably better, not only for me, but for my wife who had to tolerate the noise.”
Rydlund, who previously was having approximately 100 AHI episodes per hour during sleep, now is using this new mouthpiece. He has reduced his breathing lapses down to under 15 episodes per hour, from a severe to a mild case of OSA. “My wife noticed it instantly,” explains Rydlund. “She said there is now a little snoring in the beginning, then nothing. No more gasping and choking.”
Users of the mouthpiece report that it is comfortable and unobtrusive. It does not rely on opening the jaw and moving it forward, as conventional mouthpieces require, thus eliminating many of the side effects associated with these prior devices.
David Friedman, who also experienced an unsuccessful attempt with the CPAP, has moved on to using this new Full Breath mouthpiece. “This appliance is extremely comfortable,” says Friedman. “It is unobtrusive and almost unnoticeable. I can get up in the middle of the night. I can roll over in bed. You can’t do that with a CPAP machine. Unlike before, sleeping is now great.”
Utilizing the latest advances in diagnostics and oral appliance technology, the life-threatening symptoms of Obstructive Sleep Apnea and chronic snoring can now be significantly reduced. Those men previously afflicted can now avail themselves of a much better quality of sleep, reduced health risk and inevitably a more productive personal and professional life.
For more information, contact the Center for Snoring and CPAP Intolerance; Phone 866-598-0220; 18663 Ventura Blvd., Suite 200, Tarzana, CA 91356; email email@example.com; www.fullbreathcenter.com.
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Jim McMahon writes on emerging technologies in medical and bioresearch applications. His stories have been carried in hundreds of publications worldwide, and are read by more than five million readers monthly. He can be reached at firstname.lastname@example.org