Pure Sleep: A Treatment For Snoring Not For Sleep Apnea

The following is a copy of a press release about the Pure Sleep Appliance. The appliance works in a similar manner to appliances discussed on this site. There are problems when the pure sleep appliance is used to treat sleep apnea. It may be as good or better than any other over the counter appliance or device for snoring. The pure sleep appliance is heavily advertised on Television for treating snoring. Beware it is a treatment for snoring not sleep apnea. Www.ihatecpap.com offers cpap alternatives for treating sleep apnea.

Snoring is often portrayed as a comic problem and is great material for the writers of sitcoms. It is also a warning sign of obstructive sleep apnea a life threatening disorder that increases the risks for heart attacks and strokes 600%. An eight year study showed a 36% decrease in eight year survival in patients with untreated sleep apnea. New studies have shown that heavy snoring alone drastically increases the risks for carotid atherosclerosis. The carotid proves blood to the brain and can lead to strokes. Sleep apnea is diagnosed with polysomnography and the gold standard of treatment is CPAP or continuous positive air pressure. CPAP is basically a small compressor that blows air thru a hose and a mask that presents airway collapse while the patient sleeps. The good news is that CPAP is extremely successful in treating sleep apnea and is considered the gold standard when treating sleep apnea. The bad news is that one half to two thirds of all patients prescribed CPAP do not actually use it on a regular basis. The American Academy of Sleep Medicine in 2006 declared that oral appliances were a first line of treatment for mild to moderate sleep apnea equal to CPAP and an alternative treatment for severe sleep apnea when patients do not tolerate CPAP. Studies have shown that most patients who are given a choice prefer oral appliances to CPAP. Patients wishing to learn more about dental sleep medicine and oral appliances should go to http://www.ihatecpap.com for information about the dangers of sleep apnea and treatment with oral appliances.

Pure Sleep is advertising on television commercials that it is FDA approved for treating simple snoring and that it works the same as oral sleep apnea treatment appliances. Research in dental sleep medicine has shown that oral appliances are very effective in treating snoring and sleep apnea. Pure sleep is not designed for treating sleep apnea but for simple snoring. A quick search on the internet will find stories of patients discontinuing use of CPAP in favor of the pure sleep appliance without medical consultation with their sleep physicians. This may effect both the patients health as well as public welfare. Some patients who quit snoring become silent apneics who are at greatly increased risk of heart attacks and stroke. These patients also have a 600% increase in motor vehicle accidents an have slower reaction times than people who are legally drunk and are definitely a dangerous when behind the wheel. Drowsy driving is considered to be a bigger problem than drunk driving. A study presented at the Thoracic Society meeting showed a 300% increase in motor vehicle accidents in patients with mild apnea and no symptoms of sleepiness.

Does the Pure Sleep appliance work? It probably will be very effective for many patients with simple snoring but should never be used to replace CPAP treatment without follow-up sleep tests. It will probably produce TMJ problems for many patients. The American Academy of Sleep Medicine recommends that dentists treating sleep apnea with oral appliances have special training in treating TMJ disorders. Patient with additional risk factors should absolutely have medical consultation prior to using a pure sleep appliance. A partial listing of medical conditions that my suggest sleep apnea include: Hypertension (high blood pressure), diabetes, fibromyalgia, gastric reflex, coronary artery disease, heart disease, lung disease, Memory problems, thyroid problems, daytime sleepiness, morning headache, and TMJ disorders including headache, earache, joint clicking or popping, eye pain, sinus pain and neck pain.

The public is already familiar with the warnings and caveats when prescription drugs are advertised in the media whether it is print, radio or television. Perhaps the FDA should require similar warnings to be placed in the marketing of the Pure Sleep Appliance. The FDA should examine whether strict disclaimers should be part of the advertising when the sleep physician is not involved in patient treatment.

The warning could state that snoring is often a sign of sleep apnea that is a severe life threatening disorder. Similar warnings to commonly associated disease and conditions could be listed as well as dangers of not being properly treated. Untreated sleep apnea is a greater to risk to public health and safety health than cigarette smoking. Unlike smoking the Pure Sleep Appliance is a positive development if used properly, the danger is if it used improperly in which case it is not only a danger to the user but also to the public. We have learned from our current economic crisis how lack of regulation can cause significant problems.

The real question is, if a patient with sleep apnea uses a pure sleep appliance that quiets the snoring but does not treat their sleep apnea and an innocent child is then killed in a motor vehicle accident who is responsible. The FDA for approving the appliance without insisting on appropriate warnings, the patient who used the appliance without realizing the risks or the company who supplies the appliance to the public. The paperwork explains to the patient that the appliance is for treating snoring and not for treating sleep apnea. How does the patient know if they have sleep apnea or just snoring. There are several pages of instructions that are designed to let the company claim that patients were informed that the appliance is only meant for simple snoring but research has shown that these type of warnings are rarely read or heeded by the public. Patients can assume if they are not having symptoms of tiredness that they do not have apnea. This is a dangerous assumption. A recent study presented to the American Thoracic Society showed a 300% increase in motor vehicle accidents involving serious physical injury in patients with mild sleep apnea and no symptoms of excessive daytime sleepiness.

Heavy snoring is also no longer considered just a cosmetic problem. A study in Sleep (Sept 2008) showed a large increase in carotid atherosclerosis in heavy snorers that could increase the risk of strokes up to ten fold. This snoring is a medical disorder that the FDA has decided can be treated by use of an over the counter appliance without follow-up. I wonder if the FDA considers this an acceptable increase in risk. Hopefully the Pure Sleep appliance helps patient with simple snoring but I am worried by how many lives could be lost when it is used inappropriately. For many years the FDA did not allow the sale of this type of device on the internet. Research must have convinced the FDA that this was an acceptable method of treatment.

I am not going to answer these questions, but they are questions that need to be addressed on a medical basis by the patient and their health care providers as well as by those who insure the safety of the roads. Oral appliances are definitely a comfortable alternative to CPAP in patients with mild to moderate apnea and an alternative for patients with severe apnea who do not tolerate CPAP. Learn more about dental sleep medicine at http://www.ihatecpap.com

To learn more about the dangers of Sleep Apnea and the treatment alternatives you can use the following resources:

http://www.sleepapnea.org/awake/index.html
http://www.sleepfoundation.org/site/c.huIXKjM0IxF/b.2417141/k.27D9/Ho ... a_Poll.htm
http://www.sleepandhealth.com
http://www.ihatecpap.com/sleep_apnea_dangers.htm

BIMAXILLARY ADVANCEMENT SURGERY FOR SLEEP APNEA

Maxillomandibular surgery is an important option for some patients with severe sleep apnea who are also CPAP intolerant. Other surgeries used to treat slep apnea include UP3 or Uvulolopalatopharyngealplasty which has a very high morbidity rate and less that 50% of patients had a 50% reduction in apnea indexes and almost all patients still required either CPAP or oral appliances to treat residual apnea. Long term problems include multiple ear symptoms, swallowing problems, voice changes and velo-insufficiency with food and liquids entering nasal cavity. UP3 surgery has lost favor as a first line treatment. Alternatives to UP3 with lower morbidity were tried including LAUP or laser assisted uvuloplasty, often described as feeling like a blow torch was used in the throat and somnoplasty which is probably the most comfortable way to reduce the soft palate but requires several repeat surgeries and does not eliminate sleep apnea leaving patients still needing CPAP, Appliances or additional surgery. Pillar surgery involves placing stents in the soft palate and while it is relatively painless it is also useless for treating moderate to severe apnea but might be helpful for very mild apnea and/or simple snoring.

A newer soft palate surgical procedure involves using a sliding flap to advance the soft palate. The advantage to this surgery is that it is reversible. The biggest problem with soft palate surgeries is they increase the risk of velo-insufficiency following maxillary advancement. Because maxillary and mandibular advancement is the most effective surgical proceedure having a reversible soft palate surgery is vital. Tracheotomy is actually the single most effective surgery but is not accepted by most patients except in an emergency context. A tracheotomy lets the patient bypass the base of the tongue and breathe thru the throat. The base of the tongue and the epiglottis secondary to base of tongue pressure is the location of the majority of obstructive events. Surgery to reduce the tongue size or position include removing an anterior wedge from the tongue and letting the tongue posture forward, a median rhomboid glossectomy which removes a rhomboid shaped area from the center of the tongue. It is a challenging surgery and the physicians I have talked to have never done it more than once. I have never talked to who has had that proceedure. There are two prcoeedrures for reducing the Base of the tongue the radiofrequency or somnoplasty procedure has been shown to be as effective as the base of tongue surgery and is much easier on the patient. A paper comparing the procedures recommended that radiofrequency was preferred in spite of multiple procedures. Base of tongue reduction by either method may not cure apnea alone but will allow lower CPAP pressure and/or less advancement of the mandible for appliances therapy. It will have a positive effect relative to maxillomandibular surgery as well.

A less aggressive surgery than full maxillomandibular advancement is a genioglossus advancement. This involves cutting the chin loose from the lower jaw and bringing it forward and bolting it in place. I like to call this the "Jay Leno" surgery because everyone has the Jay Leno look after surgery. This is a good surgery for a patient with a weak or recessive chin but normal bite who would like to avoid more radical surgery. In these patients it can also be done in conjuction with maxillomandibular surgery.

Maxillomandibular advancement consists of cutting the upper jaw or maxilla loose from the skull and usually moving it downward and forward. In narrow maillas the surgeon may also cut the upper jaw into sections and then rearange the parts and either wire or bolt the bones together with titanium plates. The lower jaw is then cut into three pieces and the middle part is advanced and the parts are again either wired together or bolted with titanium screws and plates. The patient usually has the mouth wired shut for up to six weeks.

This is an extremely effective procedure and in some patients can be a cosmetic enhancement while in others it results in protrusive profile that is not acceptable. At this time I would say "let the buyer beware" This is a serious surgery and needs to be approached with caution and deliberation. I love the quote "THERE IS NO DISEASE OR DISORDER THAT CANNOT BE MADE WORSE BY STICKING A KNIFE IN IT." and I wish I knew who first said it. It does not mean you should not do surgery but rather take a cautious and informed approach to any surgery and ask about possible problems associated with the surgery.

In the case of Maxillomandibular surgery for treating sleep apnea I strongly recommend that maximum advancement with oral appliances be done before any surgery. The TAP 1 is probably the most effective appliance at achieving this position. Utilize a daytime appliance to eliminate pain or discomfort from trying to return to the original bite. If apnea is eliminated with the appliance the surgeon now has a surgical guide to determine where to reassemble the patient after cutting the jaws into multiple pieces to get the best results. This is major surgery an patients do not want to need to Need CPAP, Appliances or additional surgey to treat their apnea after going though this extensive surgery.

An article in the Journal of Otolaryngologic Head and Neck Surgery in November of 2009 reported on "Complications/adverse effects of maxillomandibular advancement for the treatment of OSA in regard to outcome" (abstract below) They reported adverse advents as well as cosmetic changes but state the patients considered these secondary to the surgical outcome. The most common side effect was mental nerve damage. This would feel like a numb (paraesthesia) lower lip to the patient similar to the feeling of having anasthetic for a filling on the lower jaw. It is also possible to have tongue paraesthesia.

The results were very good with the "mean apnea-hypopnea index decreased from 65.5 +/- 26.7 per hour to 14.4 +/- 14.5 per hour. In simple English this means that patients began with apnea-hypopnea indexes of as high as 92 to as low as 38 and after surgery the AHI was reduced to 28 to Zero. The patients with apnea indexes in the upper ranges would still need CPAP but some of the 50 patients had a complete cure. This is an excellent and effective surgical option that carries risks of adverse events and cosmetic changes. It is possible to effectiveness by oral appliance advancement as a trial to evaluate the best position to reassemble the patient.

PubMed abstract:
Otolaryngol Head Neck Surg. 2009 Nov;141(5):591-7.
Complications/adverse effects of maxillomandibular advancement for the treatment of OSA in regard to outcome.
Blumen MB, Buchet I, Meulien P, Hausser Hauw C, Neveu H, Chabolle F.

ENT Head and Neck Surgery, Foch Hospital, Suresnes, France. mbjblu@club-internet.fr
OBJECTIVE: To evaluate adverse effects/postoperative complications and surgical response rate of maxillomandibular advancement for the treatment of severe obstructive sleep apnea syndrome. STUDY DESIGN: Case series with chart review. SETTING: Otolaryngology Head and Neck Surgery Department in a teaching hospital. SUBJECTS AND METHODS: A total of 59 consecutive severe sleep apnea patients underwent maxillomandibular advancement. Systemic complications were evaluated from medical charts. Functional adverse effects and cosmetic consequences were evaluated by questionnaires. The treatment outcome was assessed by polysomnography. RESULTS: Fifty patients were evaluated. They had a mean age of 46.4 +/- 9.0 years. No serious postoperative complication was observed. The most frequent local complication was mental nerve sensory loss. Most patients reported cosmetic changes. The mean apnea-hypopnea index decreased from 65.5 +/- 26.7 per hour to 14.4 +/- 14.5 per hour (P < 0.0001). Light-sleep stages were also decreased (P < 0.0001), whereas deep-sleep stages were increased (P < 0.001). CONCLUSION: Maxillomandibular advancement can induce local adverse effects and cosmetic changes, but they seem to be considered as secondary to the patients according to the surgical outcome.

PMID: 19861196 [PubMed - indexed for MEDLINE]

Do You or Your Partner Have Sleep Apnea?

Sleep apnea is a very serious, life-threatening condition in which one repeatedly stops breathing during sleep. The periods of not breathing can last several seconds, leaving you gasping for air, and sleep apneaics may have hundreds of these episodes during one night.

There are three types of sleep apnea: obstructive sleep apnea (OSA), central sleep apnea, and a combination of the two. OSA is caused by a blockage of your airway; excess tissue may be the cause of this blockage. The blockage could be in the nasal passages, or something related to the structure of the jaw and airway may also cause the sleep apnea.

Central sleep apnea is not as common as obstructive sleep apnea. In CSA, the brain does not send the appropriate signals to the breathing muscles to produce respiration.

The causes of sleep apnea are numerous and may include:

Structural problems in the airway that cause interrupted breathing during sleep
Throat muscles and tongue relax during sleep blocking the airway
Narrowing of the airway often occurs in obese individuals due to the excess tissue in the throat and neck areas

Some people are more prone to suffer from sleep apnea than others. A staggering 15 million people are estimated to suffer from this condition with more men than women having the condition. People who are overweight, have hypertension (high blood pressure) or snore loudly are at a greater risk of developing sleep apnea. Some studies indicate that the disorder may be hereditary.

There are a variety of treatments for sleep apnea, and treatment for sleep apneaics varies from case to case. In the past, CPAP (Continuous Positive Airway Pressure) has been used but because you must actually wear a mask while you sleep. The CPAP machine uses pressure to send air flowing through the nasal passages. Other treatments for sleep apnea include:

Oral appliances
Behavioral changes
Medication
Surgery

If you think you may suffer from sleep apnea, there is help out there for you. In Gurnee, Illinois, Dr. Ira Shapira has successfully treated thousands of sleep apneaics, and he can help you, too. Please contact sleep apnea specialist, Dr. Ira Shapira at his Gurnee, Illinois dental office today.

I am interested in alternatives to CPAP Machines. I am considering a sleep study only because my Pulmonologist thinks I should take one. I have no classic symptoms. Sometimes snore, am not tired upon awakening, no headaches, don't doze off during the day, even after meals, at movies, etc. So, I am not sure what to do regarding the study...thx, bob

I WOULD DEFINITELY TELL YOU TO HAVE THE SLEEP STUDY. MANY PATIENTS HAVE SEVERE PROBLEMS BUT ARE SYMPTOM FREE. TRUST YOUR PULMONOLOGIST ON THIS ONE.
DR SHAPIRA

Improving CPAP and Appliance Comfort With PAP Pillow

I am an enormous fan of the talk about sleep website. Tracy who moderates it is fantastic. She has a company that makes the PAPillow that helps patients with sleep apnea find comfortable side positions to sleep. Patients looking to increase their CPAP comfort need to take a look at the PAP Pillow (http://www.PAPillow.com/) The PAPillwo also helps appliance patients and positional apnea patients increase side sleep, which is frequently where there is a decreased number of apnea episodes.
Dr Ira L Shapira

The folowing information is from Tracy's website:
Feel the PAPillow™ Difference!
The patented design of the PAPillow™ has solved CPAP compliance issues for thousands of CPAP users.

Helps prevent mask leaks and sore spots
Improves comfort and CPAP compliance
Helps you to achieve a good night's sleep
Designed by CPAP users, for CPAP users
All PAPillows Feature:
Sturdy construction, high quality interlock-knit
Proper support for neck and head
Accommodates both left or right side sleeping
Comfortable, hypoallergenic synthetic down fill
Quilted side panel prevents edge collapse
Machine washable, cool dryer safe
Fitted pillow case included
See how the PAPillow works
© 2000-2008 PAPillow.com. U.S. Patent No. 6,913,019. All Rights Reserved.

The BEST PRICES ON CPAP SUPPLIES AND EQUIPMENT

This site might be called I HATE CPAP! but we realize many patients like their CPAP or use it in conjunction with their oral appliances. I have recently received an e-mail from a company that promises to beat any other companies prices. I want to help all patients with sleep apnea find the most appropriate treatment. If you are a CPAP user and are concerned about the costof your equipment contact this company. Please let me know what you think of their prices and service. CPAP saves lives and and anything I can do to help CPAP users makes me happy

"comments : My name’s Nathan Frasher and I’m a marketer for BestCPAPprice.com We sell the same products that all the other CPAP websites sell except we have a Best Price Guarantee. If you find a competitor with a lower advertised price for a product that we stock, we will give you 110% of the difference! For example, if we advertise a product for $250, and a competitor has the same product advertised for $200, we will sell it to you for $195. There are also additional discounts that we can’t publish on the site due to trade guidelines. These discounts are available to customers who contact us If you would be willing to check out the site, http://www.bestcpapprice.com and possibly mention this deal to your readers, we would be very grateful."

For the best prices on CPAP contact BestCPAPprice.com If they dissapoint you I will make sure to pass on that information. If you are happy with their services I will pass that on as well.
Wishing you a happy holiday season.
Dr Ira L Shapira

What is CPAP?

Continuous Positive Airway Pressure (CPAP) has been the main treatment for people with sleep apnea. The CPAP machine works by using pressure to send air flowing through the nasal passages, keeping the throat from collapsing during sleep. CPAP, however, is uncomfortable, and many people do not use CPAP because its inconvenience and bulkiness.

If sleep apnea is left untreated, it can lead to many serious problems including:

Fatigue
Depression
High blood pressure
Diabetes
Sore throat
Dry mouth
Excessive daytime drowsiness
Poor concentration
Short-term memory problems
Anxiety
Mood swings
Impotence
Cognitive deterioration

Most of us are aware that a good night's sleep is essential. REM sSleep, the time during sleep when we dream, contributes to overall health and proper body function. But during a sleep apnea event, the individual leaves REM sleep many times throughout the night to restart his or her breathing. The result is a lack of deeply restful sleep that seriously affects the body's ability to function.

There are three different types of CPAP machines:

CPAP: delivers one continuous air pressure
APAP: adjusts to your need for oxygen by starting out at low pressure, senses raising the pressure during a sleep apnea event
BiPAP: uses a higher pressure when you inhale and lower pressure when you exhale

To learn more about snoring and sleep apnea, please contact sleep apnea specialist, Dr. Ira L. Shapira, in Gurnee, Illinois today to schedule your initial consultation.