What is a Certified Cleaning Solution, how do I clean the device?
Denture cleaning solution or tablets from your local pharmacy will work to keep the device clean. We recommend soaking and swishing the device around in a mixture of cold water for 10 minutes before taking it out to air dry. Your iSleepSound™ Snoring Solution is now ready for the next nights use!
How long does the device typically last?
On average, the lifespan of the iSleepSound™ Snoring Solution is approximately 1 year. However, it may be less or more, depending on personal use and care of the device. Patients may wish to replace it if you see signs of wear and tear and if performance is noted to have diminished over time.
Can I wear the device with dentures?
Yes, the iSleepSound™ Snoring Solution was developed with edentulous patients in mind. The flange of the device fits between your lips and gums, so patients can wear the device with or without dentures.
Is it absolutely necessary to breath through my nose when I use your product?
Yes, you do primarily have to breath through your nose when wearing our product. The device may cause obstruction of oral breathing and it is not recommended for those people with chronic nasal congestion, blockage or sinusitis. You should not use our product if you have severe respiratory disorders.
Do all clients experience the same suction from the iSleepSound™ device?
Every client is different, so the mouthpiece will act a bit differently for each client. Some of our clients find that the device suctions to strongly and makes their tongue sore at first, while others say the device does not suction enough and dislodges their tongue in the middle of the night. The third group finds it just right, and finds our device life changing with minimal effort (kinda like a “Goldy Locks” Scenario:). For the other two groups, we usually suggest a dab of Olive Oil in the bulb to provide a better seal before inserting the tongue to help it stay in place, and for the other group to leave a bit of air in the bulb before inserting the tongue so it does not suction to strongly.
I have sensitive gums, and teeth. Is your device right for me?
Patients with sensitive gums and teeth, gingivitis (chronic swollen or sore gums) or underlying medical or dental conditions that may make your gums and teeth more sensitive to contact, should consult with a physician and/or dentist before using the device to determine whether or not the product is right for you.
Does this device work when wearing a night guard?
Yes, you can wear our anti snoring device with a night guard in place and in fact, some of our clients actually wear our anti snoring device in place of a night guard since you cannot close your mouth fully with our product in. Every client is different, so you may want to consult with your dentist or orthodontist for their medical advice on this matter. Use of the device may cause tooth movement or changes in dental occlusion, gingival or dental soreness, or soreness to the temporomandibular joint. You should not use our product if you have advanced periodontal disease.
I use a CPAP machine, and am wondering whether I can use your product in place of it?
Our clinical studies support the use of our mouthpiece for treatment of mild to moderate sleep apnea. Many patients use wear our device in place of a CPAP, or to substitute for one on vacations. The condition of sleep apnea can differ in severity from person to person. Order one and try it out for yourself, or consult your medical professional to find out more about the condition of sleep apnea.
Is the device recognized in the treatment of sleep apnea?
The iSleepSound™ device is registered with Health Canada, the European commission, and the ARTG as a class I medical device and is available over the counter for the treatment of mild to moderate sleep apnea and snoring in Canada, EU, Australia and other countries listed on our website.
It is also registered with the FDA as a class II medical device and it is available by prescription for the treatment of snoring in the United States (Thus in the U.S., the device is contraindicated for use in patients who have central or obstructive sleep apnea).
Does the device have any possible side effects?
While wearing the mouthpiece, users may experience one or more of the following common side effects including, excessive saliva production, tenderness at the tip of the tongue or sore gums. These side effects should diminish or resolve completely over time.
Do not trim, cut or heat the iSleepSound™ device as this may compromise the quality of the device and make it unsafe for use.
Patients should consult with their physician or dentist, where necessary, to consider the medical history of the patient, including history of asthma, breathing or respiratory disorders, or other relevant health problems before using the device.
Snoring is the result of vibrations that occur when air passes through a constricted airway. Obstruction most often occurs at night when muscles at the back of the throat relax during sleep, causing snoring and apnea related symptoms that block airflow and the supply of fresh oxygen to the body.
MPowrx™ ‘s iSleepSound™ Snoring Solution
The iSleepSound™ alleviates snoring and OSA through its unique bulb and flange design, which pulls the tongue forward and re-positions the mandible, enabling the pharynx to enlarge and the airway to open up. The device is made from soft, thin, flexible medical grade plastic resin, which allows it to conform comfortably to many different mouth sizes with no custom adjustment or fitting.
INSTRUCTIONS FOR USE:
Step 1: Just before falling asleep place the flat flange under lips and in front of teeth or dentures or gums
Step 2: Squeeze bulb with thumb and first finger while sucking air out of the bulb
Step 3: Insert tip of tongue into bulb while releasing thumb and finger
Step 4: Relax your tongue
NOTE: The Bulb will stick out between lips (as shown in figure). It will take practice learning to swallow without pulling out the tongue.
Gently squeeze bulb and remove tongue.
CLEANING THE DEVICE:
The appliance is packaged with certified (Dentasoak®) cleaning solution. Use as directed. After cleaning: rinse, dry and store in container. Do not use stronger cleaners or hot water.
It is recommended that patients replace the iSleepSound™ Snoring Solution after 6 months. If it becomes visibly damaged, ripped, torn, stretched or if suction is no longer suitable, replace immediately. The lifespan of the iSleepSound™ Snoring Solution depends upon how frequently you use it and the conditions of its use. With proper use and care, it can last up to 1 year.
Do not trim, cut or heat the appliance as this may compromise the quality of the appliance making it unsafe.
POSSIBLE SIDE EFFECTS:
Excess Saliva, and tender or sore tongue and gums occur in some patients and may subside with use over a 6 week adjustment period. Expect the tip of the tongue to feel tingly or slightly swollen. This feeling should disappear within an hour of removing. If the tongue or gum tenderness, tingling or swollenness remains, do not use the appliance for at least one night or until it subsides.
The iSleepSound™ Snoring Solution is not recommended for patient’s with closed nasal passages, as commonly experienced during a cold or sinus congestion. The patient may have difficulty breathing through the nose when the appliance is in use.
It is important that patients be assessed for a more severe condition known as Sleep Apnea before being prescribed the iSleepSound™. A neck circumference of 48 centimeters or more is a strong indicator for sleep apnea. For more information on sleep apnea visit www.sleepapnea.org.
A randomized controlled crossover study was performed and published in the Journal of sleep and breathing (Journal of Sleep and Breathing- Dort L.). It is the first study of its kind conducted among Tongue Stabilization Devices and provides evidence that supports the use of MPowrx™’s iSleepSound™ Snoring Solution to treat snoring and OSA.
A recent peer reviewed publication in the Journal of Clinical Sleep medicine by two leading industry researchers (Journal of Clinical Sleep Medicine- Dort L, Remmers J.) shows evidence to support the treatment of moderate to severe sleep apnea using MPowrx™’s iSleepSound™ tongue retention device in combination with a mandibular displacement device.