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SleepTight Mouthpiece-Double Pack Snoring and Sleep Apnea Device


Description

The FDA cleared Sleep Tight Mouthpiece (STM) can alleviate snoring and improve obstructive sleep apnea. Snoring occurs when the airway is blocked by relaxed tissue. The STM gently holds the jaw and tongue forward to OPEN the airway and improve sleep breathing. The STM can be fitted in less than 10 minutes and immediately improve sleep for both you and your sleep partner. The STM is Effective, Economical and Easy to fit making it the right solution for people who need better sleep.

US and International Shipping

Instructions


Gather your supplies: STM Mouthpiece (with airway plug), sauce pan, cooling cup, timer, and spoon to immerse the STM.

Directions
Insert the white airway plug firmly into the front of the mouthpiece.
Boil water (enough to cover the mouthpiece) and then pour it into a cup. NOTE: Do not microwave the water. Then allow the water to cool for 60 seconds
Dip and completely immerse the STM for 180 seconds. Use a utensil to hold the STM under water.
After three minutes, remove the mouthpiece from the water and make sure the mouthpiece edges have not folded over and straighten, if necessary. Test the device to make sure that it is not too hot. Then place in the mouth to fit.

Fitting Details after Softening the Mouthpiece
Make sure that the STM is the right way up with the “V” notch up. Put it on the lower teeth first then carefully close your mouth to seat both jaws into the mouthpiece. Watch yourself in a mirror.
Bite firmly and always move the jaw forward slightly till the edges of your front teeth align (unless directed otherwise). You will see a slight rise of the white airway plug handle as the jaw advances.
While the STM is warm use the fingers and tongue to compress the soft material around your teeth and gums. Suck in. This will use the tongue and cheeks to further compress the soft material. Keep compression pressure until the mouthpiece temperature becomes normal and then cool in cold water.
Special Note: Moving your lower jaw slightly forward in the warm fitting process is the essential component of the snoring improvement feature. To keep the jaw comfortable move it forward only enough to stop the snoring. The mouthpiece can be refitted a few times if necessary.

Consumer Usage and Care
Simply place the fitted STM into the mouth while sleeping and position the tongue forward into the opening. Clean with a liquid hand washing soap and store dry in the provided case. Follow good sleep hygiene tips. If you do experience any complications, please stop using this mouthpiece and contact your dentist or other medical personnel.
Email: info@sleeptightmouthpiece.com for more information.

Warranty

Warranty
Please note Professional and Consumer FAQs are at the end of this section

Consumer Money-back guarantee
The STM alleviates and improves snoring for almost everyone. However, if it doesn’t work for you, simply return it within 30 days of shipping for a complete refund. Contact us at info@SleepTightMouthpiece.com for return instructions.

User Responsibility
As the end user it is your responsibility to read and follow all directions and safety instructions carefully before your fitting.
The user of the STM assumes all the risks and liabilities and there is no implied guarantee of safety or enhanced performance as other variables exist beyond control of the manufacturer or retailer.


Consumer Information
The Sleep Tight Mouthpiece (STM) is an intraoral mandibular advancement device intended to be used for the treatment of snoring and mild to moderate obstructive sleep apnea in adults. Rx only

Warnings
This device should not be used by persons with asthma, central sleep apnea or severe respiratory disorders. If you have loose teeth, advanced periodontal disease, TMJ (Jaw joint pain) or other dental problems consult your dentist before using this device. Use of this device may cause temporary dental problems including increased salivation or possible mouth breathing. If you experience ongoing TMJ pain, gum irritation, bite problems, loose teeth or other dental problems discontinue use of the device and seek dental or medical help. Non sterile.

SleepTight Mouthpiece
PO Box 551122
Ft Lauderdale, FL 33355
info@sleeptightmouthpiece.com

Consumer FAQs
BENEFITS
What are the benefits of the STM?
When using the STM you can expect
• Better Sleep
• Improved relationship with your sleep partner
• Better health
• More energy

Can the STM help the relationship with my sleep partner?
Snoring is the third leading cause of divorce
• Your sleep partner will sleep better without interruptions
• Users of the STM report an improvement in intimacy

Can the STM improve my health and work?
Obstructive sleep apnea can be a serious medical condition
• Snoring improvement and better sleep helps reduce the medical problems such as heart disease associated with sleep apnea.
• Improved sleep will enhance your daytime energy level
• Better sleep improves work performance and safety

FEATURES
Why is the STM better than other snoring mouthpieces?
If you have tried any other snoring mouthpiece, you will appreciate the STM features. These patented features of the STM overcome many of the problems with other mouthpieces and can make it more effective. The STM is better than most other snoring mouthpieces because it:
• Fits tighter and better
• Reduces jaw joint-muscle pain and tooth sensitivity.
• Is medically proven and FDA cleared for safety and effectiveness
• Quick to fit, easy to use and lasts longer Gives and immediate result
• is very cost effective

How does the STM fit tighter and better?
The inner core of the STM is comprised of a soft thermo plastic material.
• This inner layer when softened and cooled grips much more tightly than all other similar devices on the market.
• Visual inspection of the STM will show its dual laminate design.
• The STM fits tighter than other self-fit “boil and bite” devices because of its patented dual laminate design. This help the mouthpiece stay in place all night to hold the jaw in its stop snoring location. The STM does not fall out like other devices do.

How does the STM reduce the TMJ- jaw joint problems of other mouthpieces?
The STM allows the tongue to move forward and be retained in the large front airway opening.
• Since the tongue can come forward, unlike other mouthpieces, there is less jaw advancement required to reduce snoring. The STM less jaw advancement reduces the jaw joint stress and improves the comfort of the device.
• The STM reduces jaw joint and facial muscle pain because the tongue is gently retained in the front airway space. Most competitors either block the front airway. This results in a more forward jaw position to move the tongue away. This additional advancement causes additional stress on the jaw joint and muscles.

How does the STM reduce the teeth sensitivity found with other mouthpieces?
The STM fits tighter due to its soft inner core
• The tighter fit more evenly distributes the stresses on the teeth not just the front teeth or the side teeth. This even distribution reduces stress and teeth pain.
• It is common for other mouthpieces even the custom dentist fabricated devices to loosen teeth


Why is there a hole in the front of the STM?
Is there an emergency breathing opening?
Yes. The STM developers created a new type of snoring mouthpiece with a large front breathing opening.
• This allows the user to easily breathe through their mouth and to let the tongue come further forward during sleep which helps to further reduce snoring.
• Other sleep devices do not offer this emergency breathing opening and those devices try to force the user to use nasal breathing only.
• The large opening is helpful for people with allergies, colds, sinus problems or mouth breathers.

Why will the STM last longer?
The STM has a hard thermo plastic exterior shell
• The hard exterior shell helps resist the clenching and grinding commonly see with snoring and sleep apnea.
• Yet the exterior shell is pliable enough when heat softened to conform to the shape of almost every user.

How does the STM work?
The STM holds the tongue and jaw forward during sleep to open the airway and improve snoring.
• The most common cause of snoring is air being passed through a partially constricted airway causing vibration of the palate during breathing. The STM mouthpiece works by moving the jaw forward, which opens up the airway and stretches the palate so it does not vibrate (or vibrates less).
• The front opening of the STM also allows forward movement of the tongue as the jaw is advanced which further removes airway obstruction to improve snoring.
• Most other snoring mouthpieces prevent the tongue from moving forward or have a very small front airway opening.

Does the STM have other uses?
Yes
The fitting process will be different for other application of the STM. Please contact us directly at info@SleepTightMouthpiece.com for additional information. Some other reported uses are these:
• Pregnancy snoring device
• Night guard for clenching and grinding
• TMJ bite guard appliance
• Sports protection for athletes
• Sports performance enhancement


EFFECTIVENESS
How do I know the STM will Work for me?
The Food and Drug Administration (FDA) of the USA has fully evaluated the STM for safety and effectiveness and cleared the STM for snoring and sleep apnea treatment.
? Medical organizations recommend snoring mouthpieces
International sleep breathing organizations recommend a snoring mouthpiece such as the STM as the first treatment option to treat simple snoring and mild to moderate obstructive sleep apnea. Please read this article: http://www.aadsm.org/oralappliances.aspx
? Medical studies confirm the STM effectiveness
Numerous studies available upon request, confirm the effectiveness of snoring mouthpieces.

How can something so simple work for my snoring?
Simplicity and effectiveness was the goal of the STM engineers and developers.
• It was determined that the STM did not need to be complicated or expensive to work.
• Many of the competitor’s devices require complex tools for fitting and adjusting instead of relying on the easy to use “boil and bite” system familiar to millions of athletes.
• All the fundamentals were in place; only the technology need to be discovered, particularly the bonding of the dual laminate materials.


Can the Sleep Tight MouthpieceTM (STM) help my snoring or my sleep apnea?
Yes
• The Food and Drug Administration (FDA) of the USA has fully evaluated the STM for safety and effectiveness and they have determined that it can be marketed for snoring and sleep apnea treatment.
• Medical scientific studies prove its effectiveness.
The American Academy of Sleep Medicine and the American Academy of Dental Sleep medicine recommend a snoring mouthpiece such as the STM as the first treatment option to treat simple snoring and mild to moderate obstructive sleep apnea. Please read this article: http://www.aadsm.org/oralappliances.aspx
The STM predicates have scientifically validated studies proving its benefit. Studies available upon request


SAFETY and EFFECTIVENESS
Is the STM safe for me?
Is the STM made from safe materials?
Yes
• The FDA has cleared the STM for its intended use assuring the user and provider of its safety and effectiveness

What is the medical indication for the STM?
Snoring and Sleep Apnea
• The FDA says: The Sleep Tight Mouthpiece (STM) is an intraoral mandibular advancement device intended to be used for the treatment of snoring and mild to moderate obstructive sleep apnea in adults. Rx only

What does FDA clearance of the STM mean?
Is it important that the FDA has cleared the STM for use?
Medical device companies desiring to market a product in the US must apply to the FDA who will evaluate the device for its intended use and safety.
• The medical device company must provide extensive supporting documentation to assure the FDA that the device will be effective and safe.
• It is common for this process to take years. Once all data is provided the FDA may clear the device and allow it to be marketed for its intended use.
• The FDA has cleared the STM for the treatment of snoring and mild to moderate obstructive sleep apnea.

Who should not use the STM?
Are there medical or dental conditions that are not recommended for STM use?
If you have certain medical or dental conditions, the STM is contraindicated.
• This device should not be used by persons with asthma, central sleep apnea or severe respiratory disorders.
• If you have loose teeth, advanced periodontal disease, TMJ (Jaw joint pain) or other dental problems consult your dentist before using this device. Use of this device may cause temporary dental problems including increased salivation or possible mouth breathing. If you experience ongoing TMJ pain, gum irritation, bite problems, loose teeth or other dental problems discontinue use of the device and seek dental or medical help.

Is the STM patented?
Does the STM have intellectual property?
Yes
• The STM is trademarked and is patent pending in the US as well as internationally.

CPAP and the STM
Can the STM be used instead of the CPAP?
Yes
• Some studies show that more than one half of the CPAP patients discontinue use.
• CPAP problems include claustrophobia, face breakouts from straps, eye and nasal irritation, mouth dryness, runny nose, sore throat, stomach bloating, and breathing difficulty for people who cannot breathe through their nose. The STM is an easy to use alternative for these problems.
• The STM can be used to treat cases of mild to moderate obstructive sleep apnea. If you are using a CPAP, you should consult with your physician before you use the STM especially if you have been diagnosed with severe sleep apnea.

I am a CPAP user; can I use the STM while travelling?
Yes
• Many customers use the STM as a spare or temporary device while travelling or in remote locations where electricity is not available. Please inform your medical provider.

Can the STM be used with my CPAP?
Yes
• Some people use the STM in combination with their CPAP as a hybrid therapy to help with common CPAP problems.
• This hybrid therapy needs to be monitored by a sleep physician.


USING, ADJUSTING AND FITTING THE STM
How can I tell if the STM will work?
Use this simple test:
• Try to make a snoring sound with either your teeth closed or with your mouth open and the jaw back (like the sleeping position). Then open your mouth a little and move your jaw forward a little at a time and till you will hear the snoring improve.
• The STM help hold the jaw and tongue in this location during sleep to alleviate snoring.
• Approximate this jaw position during the STM fitting to help improve snoring.

How do I use the STM?
Simply place the STM in your mouth
• Bite into the pre-fitted teeth imprints
• Position your tongue forward into the airway opening.
• Unlike tongue retaining devices, you will be able to swallow with the STM. Try to keep the tongue forward into the opening. Most people say that there is a gentle suction effect.
• Then Sleep Tight

When will the snoring improve?
Usually the first night
• For most people you will know the first night, if the snoring improves.

How long does it take to get used to it?
Overnight
• The adjustment phase obviously varies from person to person. Usually within a week or two most of the side effects have diminished or disappeared.


Can the STM be used to determine the effectiveness of a custom snoring appliance?
Yes
• This is a very cost effective alternative to see if the patient responds to this type of treatment before investing in a dentist fabricated device.

How long will the STM last?
Six months to two years.
• There are many factors that can affect the life expectancy of your STM such as teeth grinding and clenching while sleeping and other factors such as cleaning and maintenance.
• Some people regularly purchase every six months and others who come back once every two years.

If the STM works, is there a better mouthpiece?
Possibly
• It is important to confirm that a snoring mouthpiece can help treat snoring. The STM is a very good first treatment option due to its modest cost and easy fitting process.
• If successful, you can consider a thinner better fitting and more durable custom laboratory appliance available from the dentist.
• This device is particularly helpful in determining the possible benefit of a customized device. The STM may be considered for short-term use up to about one year or as a first-line screening device to determine whether patients suffering from snoring and / or mild to moderate obstructive sleep apnea (OSA) respond positively to oral appliance therapy, the outcome of which cannot be completely predicted prior to its usage. Thus in case of no therapeutic effect, the larger investments for a customized dental lab made appliances can be avoided


How is the STM cleaned or stored?
Use a very soft tooth brush with a liquid soap and store dry.
• All STM products are cleaned in a similar fashion. First use a very soft toothbrush with a liquid soap to remove any debris. Tooth pastes often contain abrasives which can damage the STM surface over time causing it to be more susceptible to staining.
• Soaking the appliance in denture cleaner can help with staining and freshness.
• Store the device dry in its container.

Will the mouthpiece cause gagging?
Rarely
• Customers rarely mention gagging.
• Wear the STM for a few minutes at a time untill the body adjusts to having something in place.

Why do I have extra saliva?
Saliva accumulation will decrease
• The body initially interprets the mouthpiece as a food type material which requires saliva. This is common and dissipates over time

Can the STM be used with dentures?
Yes in some cases.
• If the patient has partial dentures and some front teeth in both upper and lower jaws, the STM may work.
• If the patient has a full denture in either jaw the STM will not work. You should consider a tongue retaining device such as the AveoTSD. Contact our technical department EM: info@SleepTightMouthpiece.com for more advice.

Why is the STM rough?
Water was too hot during the fitting.
• If you place a STM in water that is too hot, it becomes very rough and not wearable and may need to be replaced. However, the STM does lose some of its smoothness when put in hot water – even at the right temperature.
• Do not use a microwave oven to boil the water as it may become superheated which could affect the texture. If a microwave is the only heat source, place a wooden stirring stick inside the container to prevent superheating the water.
• Check the temperature of the device before fitting to assure that the device is not too hot.

What is the difference between the STM and a laboratory fabricated mouthpiece?
Fit and thinness:
• The STM is a “boil-and-bite” mouthpiece, which means you put a thermo-plastic tray device in hot water and then bite into it so that it takes the shape of your teeth; this is customized specifically to your teeth.
• In some cases the STM performs better than a custom device.
• Although the STM fits very well, a custom dentist device may be more secure.
• The laboratory fabricated mouthpiece is hand-made in a laboratory using a dental impression kit. The laboratory device is made using an impression of your teeth so fits more snugly and comfortably and is defined as a customized mouthpiece.
• The materials are different and the customized device is expected to last longer


How do I get the white Airway Plug Out?
Rarely but occasionally, the final cooling will shrink lock the Airway Plug making its removal difficult.
Prevention
• Do not allow the mouthpiece to overheat. Be sure to allow the proper amount of cooling time after boiling the water before immersion into the soaking cup. The main cause is having the water too hot when heat soaking the mouthpiece, it gets just too soft and squishy and then grips the airway plug.
Solution:
• If after fitting the airway plug resists easy removal, try this
Option one
• Make sure the STM is fully cooled. Squeeze the front outside section and rock the airway plug back and forth.
Option two
• Re-soften the mouthpiece in warm water, not boiling. Bite back into the mouthpiece exactly as before and begin to wiggle the airway plug a little at a time to prevent final cooling contraction of the material. This should make it easier to remove after final cooling.
Option three
• If you want to refit the mouthpiece later, coat the inside portion of the airway plug with Vaseline before the fitting. You still must keep the airway plug fully seated.

Can the STM be adjusted to be more effective?
Yes
Refit “Tweak” the mouthpiece
• If not initially completely successful, most people can see an improvement in their snoring by simply tweaking the STM mouthpiece.
• People are understandably disappointed if they find their STM does not work right away, but are then pleasantly surprised to find that with a bit of “tweaking” their snoring improves.
• Always re insert the white airway plug to refit the mouthpiece and note its initial and final position.

How many times can the STM be refitted?
Four to five times
• Usually you can refit the device 4-5 times. The material begins to stiffen after that and be less pliable.

Situation: Snoring does not improve
This is usually caused from the jaw not being held forward enough.
Solution:
• Refit the mouthpiece according to the initial instructions and move the jaw farther toward the front. You only want to do this as far as necessary to prevent jaw soreness. Note the upward movement of the white airway plug.
• Sometimes the mouthpiece can be adjusted a little at a time as the body adjusts to the new location.
• Instruct the user to position their tongue into the front of mouthpiece.

Situation: It only works at the start of the night, or falls out during the night
This situation is rare with the STM because it offers a tighter fit.
Solutions:
• Refit the mouthpiece and concentrate on compression of the softened material toward the gums and teeth.
• Suck out all the saliva when the device is first inserted at night.
• Some users have reported that application of denture adhesive keeps the mouthpiece in place enough to improve snoring.
• If the snoring does improve but does not stay in long enough, then consider investing in a laboratory fabricated customized mouthpiece.

Situation: the user says “It used to work, but now I’m snoring again”.
Some people clench their teeth during the night. This tends to stretch the mouthpiece making it loose.
Solution:
• First try to remold the mouthpiece or buy another STM, if this fails or upgrade to a lab custom device.
• The STM was designed to be sturdy enough to resist some clenching

Situation: the user says “My jaw muscles ache in the morning”
It is common during the adjustment period to experience some jaw discomfort as the body adjusts to the stretching of the jaw ligaments. This, in most cases resolves within a week or so.
Solution:
• If the problem persists, the jaw may be pushed too far forward. The mouthpiece can be refitted with the jaw not so far forward. Observe the air way plug position before and after to see a change. Refit and move the jaw back toward the normal bite location. Always use the white airway plug.
• If the snoring improves but the jaw is still sore, chew gum in the morning after removing the mouthpiece.
• After overnight use, you can also rest their chin into your palm with their arm on a desk top. Then allow the weight of your head to guide your jaw back into its usual position.
• If the jaw ache persists and or your snoring does not improve, discontinue use of the device and consult the prescribing medical or dental provider.

Situation: the user says: “My front teeth hurt when I wake in the morning”
This situation is rare with the STM since it offers an improved customized fit and the jaw position is held forward by the front and side teeth, not just the front. For most people this disappears in a couple of weeks.
Solution:
• Remolding the mouthpiece with the jaw pushed out less forward may solve the problem.
• Make sure that the edges do not flop over during the softening of the mouthpiece in the hot water as this can place too much material on the front teeth.
• The dentist fabricated custom mouthpiece may distribute the force more evenly and can be a better option, if your see snoring success with the regular STM.

Is there a warranty?
Yes.
• You have 30 days from your purchase date to verify your satisfaction with the STM for a refund.

Returns
• Contact us at info@SleepTightMouthpiece.com for return information.
• We will first try to assist you with any concern. If we cannot solve your problem, please return the device within 30 days of purchase
• Please fully describe the reason for your return. This helps us with product development.
• Email us the tracking information for your return. info@sleeptightmouthpiece.com
• Mail via USPS the device to:

Sleep Tight
PO Box 551122
Ft. Lauderdale, FL 33355
USA



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