Imagine a snoring aid that treats all sleep disorders in an instant. If it existed, we wouldn’t be spoilt for choice as we are currently.
And since we don’t live in a perfect world, the opposite is very real. The countless products lurking in the market can only leave you confused about which is best.
Among the many products claiming to solve the sleep-depriving snoring is ApneRx. The company behind ApneRX says the device is precisely built for people with mild to moderate sleep apnea.
Of course, a company will hype its products as much as it can to sell. But, the product’s actual value can only be gauged by looking at whether it works or not.
So does the Apnea RX really treat mile sleep apnea? Let’s find out. Here are some of the things we will dissect in this review.
- What’s ApneaRx
- What You Need to Know About a Company that Manufacture ApneaRx
- The Design and the Material of ApneaRx
- How ApneaRx Works
- What’s Unique with ApneaRx
- How to Use ApneaRx
- And lots more
So if you heard only half-baked information about ApneaRx, this review should help you come up with a decision. Let’s jump right in.
What Is ApneaRx
ApneaRx is manufactured by the Apnea Sciences Corporation. It is one of the unique oral devices that aims at treating mild to moderate sleep apnea. This mouthpiece maintains the user’s jaws slightly apart to allow the airflow.
In other words, it is a fully-adjustable Mandibular Adjustment Device that claims to give snorers control over their snoring habits and sleep conditions like sleep apnea.
But is that truly the case? Or is it all marketing propaganda?
Let’s scrape deeper into the company to find out.
About the Manufacturing Company
A USA company known as Apnea Sciences Corporation in California develops the ApneaRx.
And another company, called the CareFusion company, distributes the same product in Australia.
The Earlier Problem With FDA
Some time back, the company that manufactures ApneaRx encountered problems with the FDA, but that was more of a marketing case.
On May 9th, 2013, the FDA issued a warning letter to Apnea Sciences Corporation, highlighting breaches of good manufacturing practice, marketing regulation, and handling of consumer complaints.
Apparently, the company had claimed that SnoreRx would help treat bruxism, Trans-Mandibular Joint syndrome. It has also claimed the product was BPA-free without proof.
When the FDA asked Apnea Sciences company to produce the necessary evidence, the manufacturer could not provide and instead chose to remove those claims from the SnoreRx packaging.
In response, the FDA launched an investigation on the product. It found several other flaws with the company’s quality assurance procedure and record keeping.
The company lacked proper documentation, investigation, and follow up on complaints corresponding to the returned device.
What’s more, the FDA also exposed a marketing violation on the ApneaRx’s user instructions, which claim that the device is the first-line therapy for patients intolerant to CPAP and mild to moderate sleep apnea
So the FDA requested performance data to substantiate the claim. Still, there was no reputable and public available data to support the above claims.
However, the company later resolved their problems with the FDA.
Today, the product is FDA-cleared as a qualifying treatment for mild to moderate sleep apnea.
The Design and Material
ApneaRx utilizes superior dental lab quality design. This provides a precise custom-fit that’s non-oppressive of the mouth size. The device has two trays to allow the correct fitting around the user’s jaw:
- The Upper Tray
- And he Lower Tray
The top tray remains in a fixed position—attaching to the upper teeth. The bottom tray can be adjusted forward relative to the top piece in 1 to 10 mm increments.
The easy to use increment allowance permits users to clear even more airway to ease breathing even when deeply asleep.
You can adjust, readjust, set, and relock the MAD at any time with this convenient technology.
Maximum Flow Designing
The design position the jaw so that it doesn’t hinder natural breathing—even mouth breathing. The positioning allows maximum airflow during sleep to help stop snoring.
Superior Advance Designing
Unlike other sleep apnea solution, ApneaRx has no screws, springs, rods, or rubber bands
The appliance comes with an easy-to-read gauge for showing the exact size of jaw advancement.
The Posi Lock
After selecting a setting, the posi-lock allows the user to lock in securely. Still, one can readily reset it at any time.
The Thermal Fit Material
ApneaRX MAD utilizes a medical-grade copolymer material that provides a custom fit to cushion the user’s teeth and reduce teeth grinding. This maximizes comfort.
With the material and designing out of the question, let’s shift to what the company claims the device can do.
What Does ApneaRx Claim to do?
The mouthpiece claims to be a clinically proven treatment for mild to moderate Obstructive Sleep Apnea.
But the question that you’re probably asking is:
Is that truly the case?
Well, to find out the truth, we’ll scrape deeper into two specific things:
- What Sleep Apnea is
- And how does ApneaRx Treat Sleep Apnea and Snoring
Let’s get started.
What is Sleep, Apnea?
In plain language, sleep apnea is a disorder where a person pauses breathing and experiences periodic shallow breathing during sleep. It might result from several factors, but physiological or neurological conditions are, for the most part.
Sleep apnea resulting from physiologic factors is mostly mild to moderate. One can quickly treat it with an oral appliance or the CPAP.
Its core signs might be loud snoring and waking up feeling fatigued in the morning.
But sleep apnea comes in three forms:
- Obstructive sleep apnea
- Central Sleep Apnea
- Complex Sleep Apnea
Let’s break them down even to more depth.
1. Obstructive Sleep Apnea
Obstructive sleep apnea is the most prevalent sleep apnea. People with obstructive sleep apnea experience episodic instances of clogged airways.
The obstruction happens when the throat muscle relaxes. The throat muscle supports the palate tissue.
The relaxation causes constriction in the airway, restricting airflow, which might lower the blood’s oxygen level.
The low oxygen level in the blood sends a signal of the inability to breathe to the brain. In turn, the brain senses and wakes you up.
The awakening happens so fast that it’s hard to remember.
As a result, a person might gasp, snort, or choke. Episodes of pauses in breathing might occur 5 to 30 times every hour—a phenomenon that impairs deep sleep.
2. Central Sleep Apnea
Central sleep apnea is not common as other types of sleep apnea.
Unlike obstructive sleep apnea, the periodic pause in breathing in central sleep apnea originates from the brain’s inability to send signals to control breathing.
What makes it dangerous is that you will make no effort to breathe. Similarly, you might have a hard time getting sleep and stay awake.
3. Complex Sleep Apnea Syndrome
This syndrome is as a result of the existence of both central and obstructive sleep apnea. Complex sleep apnea might require serious medical attention.
That said, here is a follow-up question that brings everything into perspective:
How Does ApeanaRx Treat Sleep Apnea and Snoring
This prescription-only device functions like any other MAD device. It forces the lower jaw into a forward position to reduce the risk of obstruction in the airway.
What makes it different, and better, is the adjustment keys and the calibrator that allows the user to move the jaw a few and precise millimeters to allow improved airflow. This jaw positioning treats mild and moderate sleep apnea as well as eliminating snoring.
What Makes ApneaRx Unique?
ApneaRx is a Mandibular Adjustment Device like any other. But one thing makes it unique:
It is an adjustable MAD and is among the rare MADs approved by the FDA to treat sleep apnea.
Unlike many other snore solutions in the market, ApneaRx is an approved Obstructive Sleep Apnea treatment—a characteristic rare in MADs.
ApneaRx: Product Classification
ApneaRx is a Mandibular Adjustment Device—A boil-and-bite device.
How to Use ApneaRx
Many users claim that fitting and adjustable Mandibular Adjustment Device is the most challenging part. But it shouldn’t be difficult.
With the right guide, you can use the boil-and-bite to fit ApneaRx in no time.
In fact, the appliance comes with a step-by-step fitting guide. And if, for any reason, you find the instruction guide challenging to follow, here is an official video guide that’ll get you through the entire process.
All in all, here is a definitive guide on how to go about it:
ApneaRx step-by-step fitting guide
Boil 3-4 inches deep water, and remove the heating source.
Use tongs or spatula to put the ApneaRx into the water you’ve boiled. Leave it for about 1 ½ minute.
When the 1 ½ minute lapses, quickly dip the ApneaRx mouthpiece into ice-cold water for 2-3 seconds to get rid of hot water. The device is now ready to bite down.
Bite down through the device firmly. To make the best out of the biting process:
- Employ a sucking motion to make profound teeth molding out of the heated material. Besides, use to press the mouthpiece against the inner part of the teeth.
- From the outside, use your fingers to press the cheeks and lips to shape the molding
When your molding fits you perfectly, remove the mouthpiece from the mouth and place it in ice-cold water for a few minutes to harden your teeth impression.
Make no mistake:
Deeper teeth impressions will make ApneaRx work even better. Therefore, if the molding you created isn’t deep enough, repeat steps 1-4.
With that in mind, now let’s take a quick look at how this device’s adjustment works.
How Adjustment of ApneaRx Works
On the first 3-5 days of purchase, the manufacturer recommends you wear ApneaRx in the default setting. Specifically, they recommend you to set it at the 3mm mark—for several hours without sleeping with it to train yourself.
After the adjustment time, you can comfortably wear it at night for a good-night sleep.
If you skip these 3-5 days adjustment period and go straight to using the product at sleeping time, you’ll hardly sleep. Not because the device has any problem, But because your jaw needs some time to adjust to precise positioning.
So using the device after 4-6 days, you’ll most probably sleep well because it won’t appear foreign jaw positioning anymore.
If you fail to notice any positive change, change the setting to 4 mm, then to 5 mm, and then continue as much as you need to.
The idea is to adjust the device’s settings to the point you find a near-to-perfect setting that gets you the sleep quality you desire. And to be precise with the adjustments, you should wear one setting for a minimum of 3-5 nights before resorting to a newer setting.
Most at times, people find the device settings at 3mm or 4mm.
How effective is ApneaRx? (even recommended by the America Academy of Sleep Medicine)
Any prospective buyer would want to evaluate the efficacy of ApneaRX.
So you’d like to check on the real-world data on how this product pulls along.
The ApneaRx is clinically proven by Kaiser Permanente’s sleep study to alleviate sleep apnea and supports a better night’s sleep.
The only red flag is the limited clinical studies to support the efficacy of this product. In fact, no external organization has executed one.
However, the FDA has cleared ApneaRx as a treatment of sleep apnea.
Care and Handling of the Apnea RX
ApneaRx has little to no maintenance. But like any other oral device, cleaning is essential.
And three things are essential to remember when cleaning comes in question:
- Clean the device with toothbrush and toothpaste to prevent bacteria build-up
- Avoid using harsh chemicals like bleach or ammonia when cleaning the mouthpiece as they might react with the device and compromise its safety
- Use dentures tablets to clean areas toothbrush cannot reach
When you finish cleaning, store the ApneaRx in the casing it came with, in a cool and dry place. Ensure the appliance is always dry before storing it in the housing to retain the molding shape.
Who is ApneaRx for?
- Persons with mild to moderate sleep apnea
- Both mouth breathers and nose breathers
Who May Not Benefit from Using the ApneaRx
- Persons under the age of 18
- If you wear dentures or have dental implants
- Persons who lack all teeth
- People with chronic asthma
- Any patient is undergoing orthodontic treatment.
Is ApneaRx FDA-Approved?
FDA ( Food and Drug Administration) is a USA federal agency that regulates food and health-related products.
And ApneaRx clearly states on its package that the product is FDA-approved.
However, what does FDA approval precisely mean?
Well, FDA clearance only means that a product complies with the essential designing and safety requirements that such devices should meet.
And don’t get it wrong:
FDA approval doesn’t certify how well a product works. In other words, it only means the product won’t hurt you, but there isn’t a guarantee the product will help you either.
Are There Any Side Effects Using ApneaRx?
ApneaRx doesn’t present significant risks.
However, as with any other boil-and-bite mouthpiece, you might feel:
- Temporary jaw soreness
- Teeth or gum pain
- Tenderness of the jaw and gums
- And excessive drooling
Nearly all these conditions will fade away as you get used to the device. And the real problem usually isn’t the device but a result of the jaw’s natural adjustment to the new positioning.
When the pain persists or becomes severe, consult with your physician because that’s not supposed to be expected.
How to Get Used to Wear ApneaRx When sleeping?
To minimize these side-effects, you can wear ApneaRx 1-3 hours before sleep for the first two days. After getting used to the device, you’re right only to use it when you sleep.
What’s more, you should wear ApneaRx on the factory settings (3mm) for the first nights. If you feel uncomfortable, you can gradually adjust it by 1 mm increments (forward or backward) until the discomfort fades away.
Mostly, sleep apnea is reduceable with a setting between 3-7mm.
How Long Does it Take to Adjust to ApneaRx?
However, adjusting to the device might take 3-5 nights of consistent use, but the period may vary depending on several factors.
How Much Does ApneaRx Cost?
The ApneaRx retails for around $149.99.
But the question that brings everything into perspective is:
Is the product really worth its price tag?
First off, the company says that the company has a lifespan of a year. And upfront, AoneaRx is relatively cheap to other snore-aid products like the CPAP machine, masks, and custom-made oral devices.
However, these proven interventions might be money-well-spent in the long run.
If you’re buying from the USA, you get free shipping for orders over$99. The price of shipping to other countries may vary.
What’s the Return Policy?
Suppose you find the product unsuitable for your needs. In that case, the manufacturer requires you to lodge the product and return clams within the 30-days of purchase. Then you should email the eligible claim to firstname.lastname@example.org to obtain a Merchandise Authority Number.
The only problem is that a return will attract an admin processing fee.
Ratings of ApneaRx
- Appropriate for both mouth breathers and nose breathers because it doesn’t restrict any natural breathing
- ApneaRxcomes with a 30-day money-back guarantee
- It is FDA-approved
- It is mouldable and adjustable to maximum comfort
- MADs, in general, have a track record for treating snoring, but this goes to the extreme extent of getting approval to treat even obstructive sleep apnea
- The company has initially violated the FDA
- You must have a doctor’s prescription to get you hand to this device
- Though comfortable in the long run, you’ll barely sleep on the first nights because of the constraint on the mouth
- Cleaning might not be easy as with other MADs because of the difficulty of reaching out to the cracks and crevices with a toothbrush and periodically use a denture tablet
- You’ll experience excessive salivation when using the device for the first time
- It is a bit price for a common MAD
Can Children Use ApneaRx Device?
No. the ApneaRx requires the user to be at least 18 years old and have no history of TMD condition.
Does the product have a warranty or guarantee?
ApneaRx mouthpiece has no warranty, but it comes with an unconditional 30-days full money-back guarantee. The guarantee starts from the day of the purchase.
Does insurance cover ApneaRx?
The Medicare classifies ApneaRx under the code E0845, which is reimbursable by any private insurer. However, plenty of insurance covers varies or changes with time. You should contact your insurer to confirm the coverage policy.
Do you Require Prescription to Order this Product?
In the United States, you must have a prescription to order this device because FDA classifies ApneaRx as a Class II medical device that necessitates a prescription from a medical practitioner with a license.
You’ll need a prescription from either sleep MDs, ENTs, nurse practitioners, or dentists. All US orders must first submit an accompanying prescription by fax or email to complete the order.
Can One Breathe via the Mouth When Using ApneaRx?
Yes. ApneaRx allows the user to breathe naturally through the nose and the mouth. It isn’t wise to go for an appliance that inhibits natural breathing.
How Long Will ApneaRx Last?
Under reasonable conditions, ApneaRx will last for 6-12 months. Like any other product, the device will undergo normal wear and tear.
However, other people grind their teeth—bruxism—more than others and may, therefore, they might require frequent replacement than others.
Can one Use ApneaRx with Dentures or a Bridge?
It isn’t recommendable to use ApneaRx with this kind of pathology. You should instead consult with your dentist.
Will ApneaRx Cause TMJ?
Although ApneaRx is not fit for a person with TMJ, the product itself does not induce TMJ.
Most Mandibula Adjustment Devices work by locking the lower jaw in place. The ApneaRx design takes it further by including micro calibrations. These allow even more fine adjustments to protect the user against TMJ.
If a particular device setting causes discomfort to your jaws, all you need is an adjustment.
And if you experience a never-ending pain, discontinue using the device immediately and contact a health professional.
Whether or not you need the ApneaRx depends on your condition and how much you want to shell out on a snoring-aid.
If you’re suffering from mild-to-moderate sleep apnea, you can squeeze a lot of value out of this mouthpiece.
That said: you cant treat nasal-related snoring with this device. That would require a completely new approach.
So if you are wondering how this brand stacks up against the competition, here’s the key: Apart from ApneaRx breaching marketing terms in the past, it has gained a reputation as a reliable brand.
The product does a great job of treating obstructive sleep apnea.
Overall, the product can hold up well against other MADs in the market. You can’t deny, the Apnea RX works, and it works well.