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Frequently Asked Questions
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During sleep, the muscles surrounding the upper airway relax, allowing the base of the tongue and surrounding soft tissue to move back, against the rear of the upper airway. Air rushing through this narrowed opening causes the soft tissue to “flutter” like a flag in a breeze, producing the snoring sound.
PureSleep is molded to your teeth, allowing it to firmly but gently hold your lower teeth forward of their normal position, relative to your upper teeth. This moves the jaw forward, along with the base of the tongue and surrounding soft tissue.
By holding your jaw forward, the base of the tongue and surrounding soft tissue are also moved forward, away from the back of the upper airway. This widens the upper airway, allowing improved airflow. Since air no longer must rush through the airway, the soft tissue is far less likely to flutter, so there the sound of snoring is therefore dramatically reduced or entirely eliminated.
Yes, PureSleep was invented by a dentist and an otolaryngologist over twenty years ago. They used it in their own practices and sold it to other doctors for their practices. At the time, it was only available by prescription.
We were then the first to offer a device of this kind of device directly to consumers by working with dentists to facilitate convenient, instant prescriptions using an innovative clinically-validated algorithm. By making it so inexpensive and convenient to get this type of treatment which had previously cost thousands of dollars, we sold over a million PureSleep units in this way.
Because there have been so few problems, despite having sold so many units, we were able to demonstrate to the FDA that PureSleep is sufficiently safe and effective that it deserved to be granted over-the-counter (OTC) clearance, one of only four such devices in the United States to achieve this distinction.
Use of PureSleep may exacerbate a temporomandibular disorder (TMD) and can cause a bite shift or tooth movement. However these problems are very rarely severe and any they almost always resolve simply by discontinuing use.
Typically, the adjustment period takes about 3-5 nights of consistent use. It is perfectly normal for your jaw, teeth and gums to feel moderately sore and fatigued at first. This discomfort is much like getting braces or a retainer for the first time. However, it is not normal to experience severe, sharp or ongoing pain. These symptoms may be an indication of a more serious problem with your jaw called temporomandibular disorder (TMD). If you experience these symptoms or believe you have TMD, discontinue use immediately, contact your dentist or physician, and return your PureSleep device for a full refund.
PureSleep is an appropriate treatment for the vast majority of adults. However certain people should not use PureSleep, if:
- you are under 18 years of age;
- you have been diagnosed with central sleep apnea, which is different from
obstructive sleep apnea and far less common;
- you have chronic asthma, emphysema, COPD or any other serious breathing or respiratory disorder;
- you have loose, damaged or weakened teeth, fillings or caps;
- you have an abscess, mouth sores, bleeding gums or severe gum disease;
- you have had a dental implant within the last 3 months;
- you have braces, full dentures or sleep using another dental appliance;
- you have been diagnosed with temporomandibular joint disorder (TMD) or have symptoms of TMD such as clicking, popping, grating or locking of your jaw or jaw pain when you open your mouth, yawn or chew;
- you experience jaw or tooth pain from clenching your jaw or grinding your teeth.
Aside from legitimate anti-snoring mouthpieces such as PureSleep, there are three other types of legitimate medical devices that successfully treat snoring.
A tongue retention device is like a suction cup that holds the tongue forward. Typically it does so such that the tongue protrudes from the mouth. It essentially accomplishing the same objective as PureSleep, which is to pull the base of the tongue forward, away from the rear surface of the upper airway. The difference is that PureSleep achieves this objective by moving the jaw forward, which simultaneously moves the associated soft tissue forward, including the base of the tongue. Either way, moving the tongue forward allows more unobstructed breathing. However because tongue retention devices constrain the movement of the tongue, they can interfere with the process of swallowing, so saliva may accumulate in the mouth. For this reason, many people find it difficult to get used to using this type of device. However they are legitimate and do work.
Likewise, devices called expiratory positive airway pressure (EPAP) devices have been shown to work. They consist of air valves that adhere to the bottom of the nose and allow the relatively unfettered ability to inhale through the nose, but then limit airflow when exhaling. This airflow limitation creates back-pressure which "inflates" the upper airway during exhalation, and remarkably, the airway then remains open long enough for the next inhalation. For this pack-pressure to form, the mouth must always remain closed, so this treatment only works for people who exclusively breathe through their nose during sleep. Also, because the amount of airflow that is allowed during exhalation is so limited, it's only possible to breathe normally through the nose when the body's metabolism is very low, and this essentially only happens after you fall asleep. Until then, users must breathe through their mouth. Then after they have been asleep for a while, they automatically transition to breathing through their nose. Initially, this process can be quite unnerving to many people, limiting acceptance. And of course, people who breathe through their mouth during sleep cannot use this type of device.
It's also possible to use a CPAP machine to stop your snoring, although the are more expensive and many people consider this solution to be overkill for snoring.
External nasal dilators, such as nose strips, can improve nasal airflow, which is very helpful. However they almost never have any impact on snoring, and in the few cases where they do, the effect is very minor. However nose strips may be used very successfully in conjunction with PureSleep.
Internal nasal dilators, such as "baskets" or clips that are inserted into the nostrils to flare out the nose operate in the same way as external nasal dilators, but because they're in the middle of the nostrils, they themselves block the nasal airflow they endeavor to improve, so we advise using nose strips instead.
Special pillows, throat sprays and herbal compounds have been scientifically tested and were determined to be ineffective. Even beds that tilt up only have a very small effect on snoring.
Recently, a product has been for sale which consists of a horseshoe-shaped plastic clip and a small ball-shaped magnet at each end. The two ends of the “horseshoe” are inserted into the nostrils, and supposedly, the two magnets are attracted to each other, thereby clipping onto the bottom of the nose. This product does absolutely nothing to improve nasal airflow or snoring and is a sham. Similarly, “micro-CPAP" devices, copper bracelets and rings are a complete scam and don't do anything.
You fit your PureSleep device to your teeth much in the same way that you fit an athletic mouthpiece, by immersing it in boiling water, removing it and waiting for a short time, and then biting into the softened plastic to make an impression of your teeth. However there are two main differences.
When making this impression, you must hold your jaw forward of its normal position as you are biting down. This is important because PureSleep's mechanism of action is to hold the jaw forward of its normal position during sleep, so it's important to fit the device with your jaw in this forward position.
Also prior to making this impression, you must assemble the upper and lower components in one of several possible ways, depending on the type of bite you have. This is how PureSleep can accommodate people with an underbite, overbite or even a "deep overbite" without the need for bulky adjustment mechanisms.
This process is straightforward but must be done correctly. For this reason, we include a colorfully-illustrated twenty page instruction booklet. And if you have any problems, our customer support representatives are there to help!
Yes, you adjust PureSleep to the type of bite you have by assembling the upper and lower components in one of several possible ways. This innovative approach allows PureSleep to accommodate virtually anyone's bite without the need for bulky adjustment mechanisms.
However once PureSleep has been properly configured in this way, and once it has then been molded to your teeth, it may no longer be readjusted.
While some people may prefer the ability to readjust their snoring mouthpiece after it has been fitted, we find that this approach allows the device to slip out of adjustment too often. In contrast, PureSleep never slips out of adjustment.
Of course! We include an individualized, postage-paid, self-adhesive return shipping label with every single order. So if you aren't fully satisfied for any reason -- or no reason at all, you don't need to call anyone, print anything or pay anything. Just put your PureSleep device back into the shipping carton, tape it up, apply the self-adhesive return shipping label and drop it into the nearest USPS mailbox.
Of course, you didn't just buy PureSleep to return it -- not matter how convenient it may be. So before you take that step, we encourage you to contact our customer support representatives. They have years of experience helping people just like you to get the most out of their PureSleep device. And if necessary, they'll even arrange to exchange your PureSleep for a new one at no cost to you.
Different people can have very different results, but most PureSleep users continue to obtain excellent results for four to twelve months, but at some point, the ability of PureSleep to adhere to the teeth will begin to degrade, although acceptable performance may continue for some time.
Yes, you can use PureSleep if you breathe through your mouth during sleep as there is a lot of space between the upper and lower components of the device to allow air to freely pass. However most people breathe through their mouth during sleep because they have impaired nasal airflow, so they find that they must breathe through their mouth, even though it’s not very comfortable – or healthy. We therefore encourage people to take steps to address any nasal airflow problems. If the problem is seasonal allergies, the current generation of allergy medications are fabulous and don't make you drowsy during the day. But if you constantly have difficulty breathing through your nose at night, we strongly recommend that you see an otolaryngologist (ear, nose and throat specialist) who can quickly see what's causing the problem. Often, it's possible to make huge improvements in airflow with a very minor surgical procedure in which they remove "nasal polyps." Sometimes, it's a little more complicated, such as if you have a deviated septum, but no matter what it is, it's usually worthwhile to get it fixed so you don't wake up with a dry mouth and a sore throat. Breathing through your mouth at night can also adversely impact dental health and give you bad breath…and it’s just more comfortable.
PureSleep is an FDA-cleared medical device, which means that we must maintain an FDA-mandated Quality Management System and comply with all FDA-mandated requirements. We manufacture PureSleep in the United States from American-made materials and our customer support representatives are exclusively based in the United States. We also offer the best guarantee in the business, with an individualized, postage-paid return shipping label included with each order, so returns are as convenient as possible. When you buy PureSleep, you know you're getting a scientifically-proven product that has met the strictest requirements of the FDA with the best support in the industry!
PureSleep has only been cleared by the FDA to treat snoring -- not obstructive sleep apnea (OSA), so it should not be used for this purpose. And if you have a far less common form of apnea called central sleep apnea (CSA), you must not use PureSleep or any other type of dental device to treat your condition. Please consult your sleep specialist to explore the possibility of using a dental device to treat your OSA.