PureSleep Mouthpiece Review - Updated 2018

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PureSleep: A Reasonable Anti-Snoring Device?

PureSleep is a snoring mouthpiece which you can use to stop snoring at night. PureSleep is a mandibular advancement device (MAD) which means it's a mouthpiece that works by moving the lower jaw forward, preventing the vibration that causes snoring.

What is a snoring mouthpiece?

A snoring mouthpiece is a device which you can use use to stop snoring at night. A snoring mouthpiece is also referred to as a "snore guard", "snoring mouth guard", "anti-snoring mouthpiece" and other similar names. There are two main types of snoring mouthpieces, mandibular advancement devices and tongue stabilization devices. PureSleep is a mandibular advancement device. This means it advances the lower jaw using the teeth, not the tongue.

Review Contents

• Ratings/ Pros and Cons
• How It Works
• Video Review
• What's Included
• Precautions/ Health Info
• Product Details
• Patient Results
• Fitting Process
• Company Info
• Costs, Shipping Options And Warranty
• Cleaning
• Summary

Ratings/ Pros And Cons

PureSleep Ratings

• Overall 79%
• Effectiveness 80%
• Fitting Process 79%
• Easy to Clean 83%
• Comfort 75%
• Value 79%

Pros And Cons Of PureSleep

How It Works

How does PureSleep work?

Before:

After:

PureSleep is a self-molded retainer which reduces snoring by holding your lower jaw slightly forward of its normal position while you sleep. By keeping the jaw slightly forward, it reduces the risk of the tongue collapsing over the throat, which causes a partial obstruction of the airway. That obstruction causes snoring.

When the airway is kept open, the tissues near it do not vibrate. Snoring is caused by vibration in the airway so keeping the jaw forward, and hence the airway open, prevents snoring.

PureSleep is made of an upper and a lower piece that you can join together in one of three settings, depending on your bite. After the pieces are connected to your individual setting, the device is boiled to soften the material so that you can mold it your teeth. This take less than a minute. Once the device has been molded, you cannot further adjust it.

While PureSleep can be customized to your bite, it cannot be changed once its initial impression. You will want to have the setting in a position where your lower jaw is as far forward as possible without discomfort. This will open your airway up as much as possible during sleep, preventing snoring to the fullest degree.

Video Review

Video Review Of PureSleep

This is a video review of the PureSleep mouthpiece for Snoring Mouthpiece Review:

The video shows:

• What's in the box
• How to fit PureSleep
• Actual patient results from using PureSleep
• How to clean PureSleep

What's Included

What comes in the PureSleep order box?

The PureSleep order box:

PureSleep instruction booklet:

When you order PureSleep, you get:

• The PureSleep mouthpiece
• A fitting case with vents on it to allow it to dry when not use use
• An instruction booklet which explains how to fit and use PureSleep

Precautions/ Health Info

Is PureSleep FDA Cleared?

Yes. PureSleep is FDA cleared as a Class II medical device for treatement of snoring.

Can PureSleep treat sleep apnea?

No, PureSleep is only intended to reduce snoring. It is not intended to treat obstructive sleep apnea or any other medical condition.

Product Details

Does PureSleep actually work?

Yes, if worn correclty a whole night, PureSleep can reduce your snoring. See more details on this page for actual patient results.

How long will PureSleep last?

During regular use every night, PureSleep should last you 6-12 months.

If you grind your teeth, it could last as little as 4 months.

How much lower jaw advancement does PureSleep offer?

• The typical bite setting offers approximately 1 mm of advancement
• The mild underbite setting offers approximately 3 mm of advancement
• The severe underbite setting offers approximately 5 mm of advancement

What's the difference between PureSleep and an athletic mouthguard?

PureSleep may look simialr to a sports mouthguard but it's very different. PureSleep is designed to hold your lower jaw forward to open your airway during sleep.

Where is PureSleep made?

PureSleep is made in the United States.

An athletic mouthguard is designed only to protect your teeth from injury, it's not designed to hold your jaw in a position like PureSleep.

What makes PureSleep different from other snoring mouthpieces?

• Adjustability by using multiple settings
  • Many mouthpieces have only one jaw position
• Can be custom-molded
  • Not all snoring mouthpieces are fit this way
• Cleared by the FDA
• Made in the USA
• Biocompatibility tested
• Affordable
• Patented design
  • Few mouthpieces have a patent

Does PureSleep contain BPA?

No, PureSleep is latex-free and BPA is not added to it. PureSleep does not disclose the resin brand they use because it is a trade secret.

What makes PureSleep unique?

PureSleep is different than many other snoring mouthpieces because it has two parts which can be joined together to fit the individual's bite.

Once the upper and lower parts are fit together, they must stay in place because the fitting process solidifies the setting through heat. This makes it different than a mouthpiece like SnoreRx which can be adjusted multiple times.

If you are able to make a firm impression and the jaw setting you use works for you, PureSleep may be effective.

How Wide Is The Airway Opening?

PureSleep has an airway opening of 3 millimeters. This is too small for the tongue to stick out but enough to allow for mouth breathing.

Fitting Process

How do you fit PureSleep?

Preliminary steps:

1. Brush your teeth, if you have partial dentures, remove them.
2. Determine what type of bite you have.
   • If your upper front teeth slightly overlap your lower front teeth, that is a typical bite. Use the Typical Bite setting (the two holes closest to the front of the device).
   • If your upper front teeth meet evenly with or slightly behind your lower front teeth, use the Mild Underbite setting (user the center two holes).
   • If your upper front teeth are much farther behind your lower front teeth, use the Severe Underbite setting (user the two holes closest to the back).
   • If your upper front teeth are much farther forward of your lower front teeth, use the Overbite setting (use the two center holes and flip the device over so the top component is now on the bottom).
3. Attach the upper and lower parts of the PureSleep device in the setting that is best for you. The upper and lower components of PureSleep are designed to fit together. The top component has two plastic "teeth" that extend from the front of the unit. You will also see plastic pins, which fit into holes in the bottom component in three possible positions.
4. Fit the device using the step-by-step instructions.

Typical bite setting:

Mild underbite setting:

Severe underbite setting:

It can be difficult to know exactly which bite setting to use. You should use the setting that feels most comfortable for you that also allows your jaw to advance forward slightly. If your lower jaw doesn't advance at all, the mouthpiece will not be as effective.

Required:

• A medium size pot for heating 1-2 quarts of water
• A spatula, perferably slotted
• A timer that counts in seconds
• A toothbrush and toothpaste
• Cuticle scissors
• A towel

Step-by-step fitting instructions:

1. Boil 1-2 quarts of water in a medium sized pot to a low boil.
2. Using a spatula, slowly lower PureSleep into the pot of hot water. Do not move the device around because the two components could separate. Keep PureSleep in the heated water at a low boil for 2 minutes.
   • If the two components separate in the water, let the device cool for one minute and then repeat the process.
3. Remove your PureSleep device and wait 15 seconds for it to cool.
4. Insert the device into your mouth.
   1. Thrust your lower jaw foward as much as you comfortably can.
   2. Place PureSleep into your mouth.
   3. While holding your jaw forward, bite down very firmly into the softened plastic.
   4. Continue holding the device in your mouth for 30 seconds. Note: It is normal for your teeth and gums to feel very warm during the fitting process. If it is too uncomfortable, remove and replace PureSleep.
5. Trim away excess material for greater comfort. There may be some soft plastic at the back of the device which has been fused or melted together. This is normal and holds the two pieces together. Excess soft plastic may have been displaced or created during fitting and this could bother your tongue. Hold PureSleep with a towl and carefully cut away any excess material using cuticle scissors.
6. Confirm the impression. If you did not make a firm impression, you can try re-fitting the device in the hot water again. You can only re-fit the device three times, after this the material may become too weak to be effective.

Common mistakes in fitting:

• If you do not wait 15 seconds after removing PureSleep from hot water, you could burn your mouth.
• If you wait longer than 15 seconds to bite into the device after removing it from hot water, you won't get a deep impression.
• Most people naturally move their lower jaw backwards when they bite down. Hold your lower jaw foward with your hands while biting down.
• Don't be afraid to bite down firmly. A deep impression will give better comfort and effectiveness.

What does PureSleep look like after fitting?

You should see clear impressions of your teeth in PureSleep when you are done fitting it.

How long does it take to get used to PureSleep?

At first, some people may have trouble sleeping with PureSleep. The adjustment period should take about 3-5 nights of consistent use. It's normal for your teeth, jaw and gums to have some soreness as you get used to the mouthpiece.

If you experience severe, sharp or ongoing pain, you should discontinue use of PureSleep because it may indicate jaw problems (TMJ/ TMD). If this happens, you should call your dentist.

Wearing PureSleep may cause some excess salivation or a slight "gagging" response. If this happens, make sure you have trimmed away all excess soft plastic. You can get used to wearing it by wearing it before bed.

If the device bothers you while sleeping, you should take it out and go back to sleep. In just a few nights you should sleep be able to sleep with it longer until you can wear it an entire night.

Again, you may have some jaw, teeth or gum soreness as you get used to wearing the device. If you stop wearing it before your jaw adjusts to it, you may need to re-adjust and go through this phase again.

If you want to shorten the time it takes to get used to wearing PureSleep, you can perform "jaw stretching" exercises in the morning. To exercise your jaw, gently push your jaw backwards while relaxing the muscles in your jaw. Hold this position for about one minute.

You should not experience severe, sharp pain when using the device. If this happens, you may have TMJ issues and should stop using the device immediately.

Patient Results

Actual Results Of Wearing The PureSleep Mouthpiece

These are results from a patient who wore PureSleep for three nights. You can see the before and after results which indicate that PureSleep was able to reduce snoring each night.

Each night the patient recorded their sleep using SnoreLab, a snoring app.

Before:

After:

Night 1:

Night 2:

Night 3:

• After using PureSleep, the patient felt the device was mostly comfortable to wear.
• They mentioned they needed to cut off the end edges of the device because they stuck out too far.

Oxygen Saturation Report From Using PureSleep

The patient who tested PureSleep for three nights also wore a pulse oximeter during part of their test. These results indicate that the patient was able to breath effectively at night with the mouthpiece in.

Note: oximeter used in recording was the CMS50E

Costs, Shipping Options And Warranty

How much does PureSleep cost?

In total, $69.85. You can try PureSleep for 30 days for just $9.95. If you keep it past 30 days, you pay an additional $59.90.

What is the return policy of PureSleep?

You have 30 days from when you order the device to redeem the PureSleep money-back-guarantee. This is more than enough time to get used to the device and know if it will work for you.

How long does it take to get PureSleep, after ordering?

• Online orders:
  • Can take 2 weeks with standard shipping.
  • Can take 1 week with rush shipping
• Over the phone orders:
  • Can take 3-4 weeks with standard shipping
  • Can take 1-2 weeks with rush shipping

Order outside the United States and Canada take longer.

Can you buy PureSleep on Amazon, CVS, Walmart, Walgreens or other stores?

No. In the United States you can only buy PureSleep directly from their website. PureSleep is a medical device and needs to be sold direct to you.

Company Info

Is PureSleep BBB Accredited?

Yes, PureSleep has a BBB listing with an A+ review.

Is PureSleep patented?

Yes. PureSleep has a patent in the United States, No. 5,499,633.

Who invented PureSleep?

PureSleep was invented by Dr. Douglas Fenton, DDS, and the late Dr. Bernard “Buzz” Kramer, MD, an ear, nose and throat specialist.

Cleaning

How do you clean and care for PureSleep?

When not in use, store PureSleep in a cool, dry place.

Periodically, clean PureSleep with a toothbrush and toothpaste, or soak in water with effervescent oral device cleaning tablets.

Do not use harsh chemicals or household cleaning products like bleach or ammonia.

Clean PureSleep more often it get stains or odors.

Summary

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