So how does it work?
FreePap helps treat OSA and improves snoring by the airway channel of the device maintaining airway patency. FreePAP is a revolutionary oral appliance. It has the stability and anchoring benefits of a mandibular advancement device (MAD) but does not pull on the teeth or lower jaw. And it functions by stabilizing the tongue similar to tongue-retaining/stabilizing devices (TRD/TSD) without protruding the tongue outside the mouth. It also functions to support the upper airway dilator muscles to maintain airway patency. The airway channel is an H beam design that supports a space between the tongue and soft palate and posterior pharyngeal wall. The device is curved to anatomically fit into the oropharynx to relieve upper airway obstruction caused by the tongue or epiglottis contacting the posterior pharyngeal wall.
The oral appliance displaces the base of the tongue from the posterior pharyngeal wall and breaks contact between the tongue and palate. The device helps retain the tongue in an anterior position and maintains airway patency between the tongue and soft palate. Retaining the tongue in an anterior position also encourages patency of the nasopharynx along with the oropharynx.
Several features of the device help patients and users overcome any discomfort caused by the anatomic positioning of the oral appliance. The H beam design of the airway channel is mated to the entire surface of the palate. This results in pressure from the tongue being distributed over the widest surface area possible on the tongue and palate, and minimizing uncomfortable pressure points anywhere in the mouth. The oral appliance is custom fitted to the entire upper dentition and palatal vault in order to maximize comfort and overnight retention of the device.
How do we make it comfortable?
FreePap is made of medical-healthcare grade USP class VI silicone that is softer than human muscle and tissue. This softness in combination with pressure distribution and patient-specific custom fitting maximizes patient comfort. The mouthguard portion of the oral appliance fitted tightly to the user's dentition helps secure the device in the appropriate therapeutic position and helps maximize overnight retention.
The acclimation process for using FreePap makes it easy to use and more comfortable over time. The oral appliance is provided in multiple stages with the airway channel provided in several lengths. The first stage has a depth into the oropharynx no further than the last tooth or hard palate. This depth into the oropharynx is similar to an upper denture. Some user's will have a pharyngeal reflex (gag reflex) response to any new object in the mouth.
The custom fit of each FreePAP is intended to minimize the pharyngeal reflex because it is very soft and closely mated to each patient's oropharynx. The device is soft, flexible, and pliable enough to allow user's to swallow with the device in place.
Getting used to your FreePAP
We send you 5 stages of FreePAP as part of the acclimation process. Each stage increases in depth into the upper airway until a stage is reached that reduces snoring and relieves OSA. The first stage is about the same depth into the airway as a new denture, at about the depth of your last rear tooth. We recommend you wear your new FreePAP 1-2 hours before bedtime. Preferably you can do activities like reading a book, watching television, etc. while wearing your new FreePAP, hopefully creating only positive associations with your device. If you feel comfortable enough to actually fall asleep with the device, feel free to do so, but this is not necessary.
Once you feel comfortable with the first stage and are no longer feeling any potential pharyngeal reflex response, move onto the next stage. Again, sleeping with the each new stage is not necessary. What's important is that you are conditioning your pharyngeal reflex from evoking a response, which should not be very difficult because of how closely fitted the device is to your natural anatomy.
How long does each stage last? Anywhere from a few days to a few weeks, the most important thing is that you become comfortable with each new stage. It is not likely you will need to go through all 5 stages in order to reduce snoring or relieve your OSA. Once you reach the stage where you can no longer voluntarily simulate snoring or airway obstruction similar to OSA, you have likely reached the therapeutic length. Patients suffering from snoring can try to sleep with this therapeutic length and see if it improves snoring symptoms. Patients suffering from OSA should repeat a sleep study to confirm this particular stage is relieving their OSA.
Step 1: Initial Consultation
For those who experience partial airway obstruction commonly referred to as snoring but not OSA, we do strongly recommend a home sleep apnea test prescribed by your primary care or sleep physician to rule out OSA. If you believe you only experience snoring and not OSA, or if a sleep study has confirmed you only snore without OSA, continue to Step 2.
If you have been diagnosed or suspect you have OSA, meet with a FreePAP sleep provider. If you have not have not taken a home sleep test before, one will be ordered for you. A convenient home sleep test will help determine if you have OSA. If OSA is confirmed by the home sleep test (HST or HSAT) or you have already been diagnosed with OSA, you will be referred to a dental sleep medicine provider.
Step 2: Impression
Whether you experience snoring or OSA will determine where and how you will be fitted for FreePAP.
For our user's who only experience snoring but not OSA, we can build your anti-snoring device from the comfort of your own home. We will send you an impression kit for your upper dentition and palatal vault. In order to make your FreePAP with the best fit and most comfortable possible we will need your impression to include all of your remaining teeth and as much of your palatal vault and hard palate as possible. This means for someone who has all their teeth, the impression should include all the way up to the last rear tooth and the height and shape of your palate should also be included. If this is difficult for you, we can refer you to a dentist that will make a physical impression or use an intraoral 3D scanner. That impression will be sent to us and we will build the 5 stages of FreePAP and send them back to you.
For user's who have been diagnosed with OSA, their upper mouth impression will be taken by their dental sleep medicine provider. Your dental sleep medicine specialist will send us the impression and we will build the 5 stages of FreePap and send them to your specialist. You will meet with your dental medicine specialist and they will guide you through the fitting process and instructions.
Step 3: Getting used to your FreePAP
Stage 1 is similar in size to a denture. This first stage should be worn for 1-2 hours before bed time. While wearing your new FreePAP, you should engage in relaxing activities like reading or watching your favorite shows. You are creating positive associations with your device that will ultimately help you sleep better. It is not necessary to sleep with your FreePAP yet, but if you feel comfortable enough with your device to sleep with it, feel free to do so.
Stage 2 is just slightly longer into the oropharynx. Again, you should follow the same acclimation process as Stage 1.
Stage 03 and 04
Each stage is progressively lengthened until the desired result is achieved. Once you reach the stage where you can no longer voluntarily simulate snoring or obstruction while your device is in place, this is most likely your therapeutic length. You do not need to proceed to the next stage. Improvements in snoring can be verified by a bed partner or roommate. For patients suffering from OSA, a sleep study should be repeated to confirm this stage of the device is relieving OSA.
This stage may not be necessary if your symptoms are already improving. Please feel free to progress to stage 5 if you feel you could benefit from it. Please contact FreePAP, your sleep physician, or your dental sleep medicine provider if your symptoms have not improved with stage 5.
Step 4: Success!
FreePAP titration study. If your symptoms improve and this is confirmed by a bed partner, there may be nothing more for you to do. We will send you a new device every 30 days for safety and hygiene purposes, just let us know which Stage of the device was successful for you.
If your sleep physician wants to confirm the effectiveness of your FreePap, they may order you a HSAT (home sleep apnea test) or titration study at an in-lab sleep study center to confirm FreePap's effectiveness.