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:
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information on sleep apnea, sleep apnea treatment and cpap alternatives are available at www.ihatecpap.com This is the premiere site for the promotion of Dental Sleep Medicine and Sleep Apnea Dentisits.