Here at The Pure Sleep® Company, we strive to make the purchase, fitting and nightly experience as easy as possible for our customers. If you donâ€™t see the information you are looking for, please submit your question(s) through our online Support, and weâ€™ll get back to you with an answer shortly!
For general questions about purchasing, fitting and the ongoing use of your PureSleep® device, consult our list of FAQs.
You can read more detailed clinical information about the safety and efficacy of MRDs as a treatment for snoring.
Frequently Asked Questions
How does the PureSleep® device work?
When a person sleeps, their throat muscles relax, their tongue falls backward, and their airway becomes narrower. When this happens, breathing can cause the walls of their throat to vibrate, causing the sound of snoring. The PureSleep® device works by a technique called mandibular repositioning - it gently holds the lower jaw forward, opening the airway thereby addressing the fundamental cause of snoring. There is significant clinical research supporting the use of this technique.
Is it safe?
Mandibular repositioning to reduce snoring has been safely prescribed by dentists and physicians for over a decade, and the PureSleep® device has a remarkable record of safe and effective use. In fact, PureSleep® has been used by thousands of snorers without a single FDA reportable adverse event. As with all medical products, you should carefully read and follow all instructions and labeling before use to ensure that PureSleep® works safely and effectively. See how PureSleep® works.
Why do I need to answer a questionnaire to get the PureSleep® device?
The PureSleep® device is a Class II medical device which requires a prescription from a licensed dentist or physician. Our questionnaire guides you through a set of questions one would get from their doctor and ensures that you do not have any other conditions that might compromise the safety and effectiveness of the PureSleep® device.
Why does PureSleep® require a prescription?
The PureSleep® device is a Class II medical device which has been cleared by the FDA for sale exclusively by prescription through The Pure Sleep® Company and its physician and dentist partners.
How difficult is it to fit?
Fitting the PureSleep® device is quick and easy: Immerse the device in boiling water, remove it to cool and mold it to the shape of your mouth. We include a step-by-step Instruction and Fitting Guide in your PureSleep® kit which you should read carefully in detail before fitting.
Is the PureSleep® device adjustable?
Yes, PureSleep® is adjustable. There are 3 settings for different types of bites. Once molded, however, that setting cannot be changed.
Does it hurt? Is it difficult to get used to wearing?
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 use. 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/TMJ). If you experience severe, sharp or ongoing pain or believe you have TMD/TMJ, discontinue use immediately, contact your dentist or physician, and return your PureSleep® device for a full refund. Customers can call the PureSleep® Helpline at 1-866-879-3777 to speak with a dedicated US customer service representative about any questions. Safety and customer satisfaction are The Pure Sleep® Company's top priorities.
What if it doesn't work for me? Can I return it?
Absolutely. But we know you didn't buy it just to return it, so please give our dedicated US customer service representatives a chance to help you with the adjustment and fitting process by calling our PureSleep® Helpline at 1-866-879-3777. And if within 30 days you need to return or replace the unit due to a mis-fitting, we are happy to make the exchange or refund your money.
How often should I replace my PureSleep® device?
Each PureSleep® device undergoes normal wear and tear through the course of nightly use. PureSleep® may last six to twelve months for some users, while others, especially those that grind their teeth, may experience evidence of wear and tear and need to replace their PureSleep® after as little as four months.
My spouse who snores, and I'd love to give PureSleep® as a gift. Is there a way to do that?
Yes, the PureSleep® device makes a great gift for loved ones who snore. It's easy to give PureSleep® as a gift - simply call 1-800-283-2667 to purchase a gift code credit. Your loved one can then call us with their gift code, take the phone-based prescription questionnaire, and the device will be sent to them. And if for any reason the PureSleep® device cannot be prescribed for them, we will refund your money in full.
How does PureSleep® differ from the athletic mouthguards I see at my local sports store?
Though it may look similar, the PureSleep® device is very different from an athletic mouthguard. PureSleep® is an adjustable device designed to hold your lower jaw forward to open your airway while you sleep. Unlike athletic mouthguards, our patented device is made from two different high-quality plastics: a hard plastic on the outside and a soft plastic on the inside, which gives it more structural rigidity, making it less bulky and more comfortable. Our device is manufactured here in the USA with only American-sourced, biocompatibility tested materials. Finally, an athletic mouthguard is only designed to protect your teeth from injury; it is not designed to hold your jaw in a specific position, like the PureSleep® device does.
How does PureSleep® differ from other mandibular repositioning devices (MRDs)?
There are several key differences between the PureSleep® device and other MRDs. Consumers should be aware of cheap imitators. The PureSleep® device is:
Most competitor products have only one setting, and unlike other MRDs and athletic mouthguards, our patented design includes two different kinds of high-quality plastic: a hard plastic on the outside and a soft plastic on the inside which gives it more structural rigidity, making it less bulky and more comfortable.
What is the PureSleep® device made of, and does it contain BPA?
The resins used to manufacture the PureSleep® device are biocompatibility tested, latex-free and cleared for manufacturing use by the US FDA. BPA is not an additive. The resin brand names, however, are a trade secret the company does not disclose.
Is the PureSleep® device regulated by the US Food and Drug Administration (FDA)?
Yes, PureSleep® is cleared by the FDA to reduce snoring in adults, and our manufacturing facility is inspected by the FDA.
How long does it take to get my product after I've ordered?
Orders received online shipped to customers in the continental US will generally arrive in 2 weeks via standard shipping and 1 week with rush shipping. Orders received over the phone take slightly longer to process and generally arrive within 3-4 weeks (standard shipping) and 1-2 weeks (rush shipping). We do ship to a select list of countries outside the US including Canada. International orders outside Canada are shipped air mail and, as in Canada, are subject to the local duties and customs clearance procedures of each country.
Can PureSleep® be used to treat obstructive sleep apnea (OSA)?
PureSleep® is intended only for the reduction of snoring in adults. It is not currently intended to treat obstructive sleep apnea (OSA) or any other medical condition or disease. If you have OSA, talk to your physician about treatment options.
What is the difference between Obstructive Sleep Apnea (OSA) and Central Sleep Apnea?
According to the Mayo Clinic, central sleep apnea is a disorder in which your breathing repeatedly stops and starts during sleep because your brain doesn't send proper signals to the muscles that control your breathing - unlike obstructive sleep apnea, in which you can't breathe normally because of upper airway obstruction. Central sleep apnea is less common, accounting for fewer than 5 percent of sleep apnea cases. Central sleep apnea may occur as a result of other conditions, such as heart failure and stroke. Sleeping at a high altitude also may cause central sleep apnea.
Treatments for central sleep apnea may involve addressing predisposing conditions, using a device to assist breathing or using supplemental oxygen. Do not use the PureSleep® device if you have central sleep apnea.
Can I buy PureSleep® through my dentist?
Yes, any licensed dentist or physician in the US or Canada can prescribe PureSleep® for you through our Dental and Medical Partner program. If you are a medical or dental professional, we invite you to join the PureSleep® Partner program.
Clinical studies show that mandibular repositioning devices (MRDs) work well as a treatment for snoring. There are a variety of other treatments available, but we believe MRDs are the most effective treatment for snoring and hereâ€™s whyâ€¦
Surgery works but itâ€™s extremely expensive, there are risks, and snoring can reoccur after a couple of years.1 Nasal dilators, like nose strips, may help a small percentage of snorers because the shape of their nostrils is too narrow, thereby restricting nasal airflow, but thatâ€™s not the typical reason most people snore. Special pillows can provide modest relief, but mainly because they encourage people to sleep on their sides instead of their backs, where snoring is normally worse. Aside from this benefit, they offer little, if any relief. Throat lubricants (which are typically sprays) have been proven not to work. 2
â€śDoes an oral appliance reduce palatal flutter and tongue base snoring?,â€ť Stouder, Jones, Brietzke, and Mair, Wilford Hall Medical Center, San Antonio, TX, Otolaryngology â€“ Head Neck Surgery, May, 2007.
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â€śOral appliances for the treatment of snoring and obstructive sleep apnea,â€ť S.R. Schoem, Connecticut Childrenâ€™s Medical Center Dept. of Otolaryngology, Hartford, CT, Otolaryngology â€“ Head and Neck Surgery, February, 2000.
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â€śOral appliances in the treatment of obstructive sleep apnea and snoring,â€ť E.T. Ayas and L.J. Epstein, West Roxbury Veterans Affairs Medical Center, Pulmonary Division, Roxbury, MA, Current Opinions in Pulmonary Medicine, November, 1998.
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â€śState-of-the-art in the treatment of snoring and sleep apneaâ€ť (translated from Dutch), H.J. Remmelink, Ned Tijdschr Tandheelkd, January, 2003.
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â€śTen-year follow-up of mandibular advancement devices for the management of snoring and sleep apnea,â€ť Jauhar, Lyons , Banham, Cameron, and Orchardson; Department of Restorative Dentistry, Glasgow Dental Hospital, Glasgow, UK, Prosthetic Dentistry, April, 2008.
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â€śPrinciples of mandibular advancement device applied to the therapeutic of snoring and sleep apnea syndrome,â€ť Petitjean, Chammas, Langevin, Philit, and Robert, Laboratoire des Troubles Respiratoires liĂ©s au Sommeil, HĂ´pital de la Croix-Rousse, Lyon, France, Sleep, June, 2000.
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"Oral appliances in the treatment of obstructive apnea and snoring,â€ť Veterans Affairs Medical Center, Roxbury MA, Current Opinions in Pulmonary Medicine, November 1998.
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â€śMandibular advancement devices for the control of snoring,â€ť Churchill Hospital, Oxford UK. European Respiratory Journal, 1998.
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1 Laryngoscope. 2009 August; 119 (8):1617-20. â€śRadiofrequency-assisted uvvlopalatoplasty for snoring: Long-term follow-up.â€ť Stuck BA.; Ear, Nose & Throat Journal, Nov 1999. â€śSnoring surgery: Which one is best for you?â€ť, Philip D. Littlefield, Eric A. Mair
2 Otolaryngology Head Neck Surgery. 2004 Jun;130(6):649-58, Popular snore aids: do they work?, Michaelson PG, Mair EA., Department of Otolaryngology-Head and Neck Surgery, Wilford Hall USAF Medical Center, San Antonio, TX 78236, USA.