Call For Feedback: Puresleep.com Dental Device

rooster wrote:I say sell it only in a bundled package with a good pulse-oximeter and plenty of instructions and warnings.

johnnygoodman wrote:Howdy All,

The tribe has spoken. Puresleep is off the island.

echo wrote:

rooster wrote:I say sell it only in a bundled package with a good pulse-oximeter and plenty of instructions and warnings.

..and a discount coupon for your nearest mortuary.....

Guest wrote:LOL what scientific research goes on here....

Guest wrote:LOL what scientific research goes on here....

ractar28 wrote:It looks like it might work as a "dental tray" for teeth bleaching products.

The principle of PureSleep is simple: it moves your lower jaw forward, opening the passageway enough so that air moves through unobstructed.

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.

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 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 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.

Specially made dental appliances called mandibular advancement splints, which advance the lower jaw slightly, and thereby pull the tongue forward, are a common mode of treatment for snoring. Typically, a dentist specializing in sleep apnea dentistry is consulted. Such appliances have been proven to be effective in reducing snoring and sleep apnea in cases where the apnea is mild to moderate. Mandibular advancement splints are often tolerated much better than CPAP machines. Possible but rare side effects include gradual movement of the teeth, Temporomandibular joint disorder, excess salivation and gum irritation.

Over-the-counter mandibular advancement splints provide the same benefits if fitted correctly. They are usually made from an EVA polymer and are similar in appearance to protective mouth-guards worn for sports. One disadvantage of the cheaper devices compared to the professionally fitted devices is the difficulty in setting up the correct jaw position. An over-advanced jaw results in jaw joint pain, whilst an under-advanced jaw produces no therapeutic effect.

Devices such as nose clips can dilate the nostrils and other devices can alter jaw mechanics to keep the jaw in an optimum position. Different aids and practices may work for different people. According to a 2005 article in the British Medical Journal, playing the didgeridoo can also help, as it increases muscle usage in the throat . However, snoring is a recognized medical problem and people who snore should always seek professional medical advice before relying on techniques which may mask symptoms (i.e. snoring) but not treat the underlying condition.

rud3dog wrote:I don't believe the device is usable anymore, but would be curious to know if and how it would work along with my cpap machine?