eXciteOSA®: NEW Daytime treatment for snoring and mild sleep apnea in 2023
Today, we will be exploring a new and unique treatment for snoring and apnea called eXciteOSA®.
Article updated: 9-1-2023
As for non-sleep treatment choices, evidence has concluded that playing several types of musical instruments helps reduce snoring and obstructive sleep apnea. We covered this topic in the article, Can Playing Musical Instruments Treat Obstructive Sleep Apnea, UARS and Snoring.
For those who would like an easier option than investing in a didgeridoo, double wind instrument and accompanying lessons, eXciteOSA® daytime treatment shows some promise for primary snoring and mild obstructive sleep apnea patients.
What is eXciteOSA®?
eXciteOSA® is different from most commonly recommended snoring and apnea treatment options because it is a daytime treatment. It is currently FDA approved for the treatment of primary snoring and mild obstructive sleep apnea (OSA) in adults 18 years or older.
Obstructive sleep apnea and primary snoring (absence of apnea) are diagnosed through a sleep test. Mild OSA is considered an AHI index of 15 or less.
eXciteOSA® is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backward and obstructing the airway during sleep.
What does the eXciteOSA®look like?
The excite ISA consists of a mouthpiece that can be removed from the base unit.
Is there more than one size of eXciteOSA®?
There is only one size of eXcite mouthpiece.
How long has it been in production?
eXciteOSA® received FDA approval in February of 2021. The full commercial launch occurred in April of 2021.
How does eXcite work?
eXciteOSA® uses NMES or Neuromuscular Electrical Stimulation therapy.
eXciteOSA® consists of a compact U-shaped medical device that inserts into the mouth.
The device gently delivers low-frequency neuromuscular electrical stimulation through 4 electrodes that rest on the tongue.
The electrical current reaches the genioglossus, altering the fibers and ultimately improving muscle tone.
As a result, when a patient is at rest, there is less chance of airway collapse that causes snoring and sleep apnea.
A more detailed description of the eXciteOSA® device:
“According to clinical research in skeletal muscle stimulation, NMES has been shown to result in a change in myofibrillar protein expression to induce a phenotype shift from fatigue prone to fatigue resistant fibers with a strengthening of the cytoskeleton. In summary, Excite OSA innovative is medically proven daytime therapy trains the tongue and upper airway muscles to be more resilient against mild OSA and snoring.” (Source Excite OSA)
How do you use eXciteOSA®?
The eXciteOSA® treatment is easy to use. Insert the device into the mouth, and it rests on the tongue.
eXciteOSA® medical device consists of 2 phases of therapy:
Phase 1 Therapeutic Phase
- Use for 20 minutes a day for 6 weeks
Phase 2 Maintenance Phase
- Use for 20 minutes a day 2x per week, indefinitely
Patients can use the eXciteOSA® oral device any time of day or evening.
Times that patients have used the eXciteOSA® device includes: sitting at a desk, reading, and watching television.
Will the eXciteOSA® device hurt my mouth?
When the eXciteOSA® device is engaged, a strong pulsation is felt, not pain.
When you use the eXciteOSA® device, a patient will need to use a phone app (I-phone or android) that gives the person control to increase or decrease the intensity level.
The patient usually starts at a Level 2-3 and gradually increases over the next 6 weeks to reach Level 15 — the larger the number, the stronger the pulsing sensation.
What are the most common side effects of eXciteOSA®?
At this point, no serious adverse effects have been found during eXcite therapy.
The most commonly reported side effect to date is the pooling of saliva. You may remove the device, swallow, and then reinsert it when this happens.
Other transient side effects are rare but may include mild tongue or tooth discomfort, tongue-tingling, metallic taste near dental fillings, and gagging.
None of these side effects have been shown to last once the device is removed and turned off. Also, the side effects diminished significantly as therapy continues.
Is the concept behind eXciteOSA® new or taken from other therapies?
Although NMES (neuromuscular electrical stimulation) has been used for quite some time in applications such as sports medicine, stroke rehabilitation and atrophy prevention, Signifier Medical has orchestrated NMES in a new medical arena, that of treatment for snoring and apnea.
At this point in time, the company presents eXciteOSA® as a new method for snoring and apnea treatment with no current competitors for this type of treatment.
Who best benefits from eXciteOSA®?
The eXciteOSA® is indicated for patients with primary snoring or mild obstructive sleep apnea.
Other uses are being researched currently, such as in moderate to severe apnea and if it could be used as an adjunct therapy to other treatments.
Who should NOT use the eXciteOSA device?
Currently, eXcite is contraindicated for the following:
- Pregnant patients
- Have a pacemaker or implanted electrodes
- Diagnosed with an AHI (Apnea-Hypopnea Index) of greater than 15
Are there any dental or oral considerations contraindicated for eXciteOSA®?
When this article was originally written in 2022, there were contraindications with patients having a variety of metal dental restorations such as amalgam (silver) fillings, implants and crowns containing metal. These contraindications were for patients in the United States and were not present in European markets and more due to a patent formality than a true danger.
In early 2023, Signifier Medical Technologies announced that the FDA approved lifting of dental contraindications for exCiteOSA. This change will allow eXciteOSA to target a much wider population base for potential treatment.
Does a patient need teeth to use the eXciteOSA®?
Candidates for using the eXciteOSA® can be edentulous (have no teeth).
This is quite exciting because, until now, there are limitations for denture wearers as to the types of non-PAP such as treatments that are retentive, effective, and tolerated by these patients.
For many denture patients, getting dental implants to help support an oral appliance or obtaining a tongue stabilizing retainer was the most common but not necessarily the best option.
The first option, dental implants, may be cost-prohibitive for many people, especially realizing that an oral appliance supported by dental implants may not necessarily lead to successful oral appliance therapy. (Oral appliance therapy is successful on average in 70-80 % of patients).
The second option, the use of tongue stabilizing retainers such as the AveoTSD, is often not tolerated readily by edentulous patients. However, it may be a viable and successful option for some snoring and apnea edentulous (full denture) patients.
It will be interesting to see more studies using the eXciteOSA® for edentulous, snoring and apnea populations.
What research is there backing up eXciteOSA® Outcome and success rates?
Research has demonstrated that eXcite may be effective in mild OSA (less than 15 events per hour) or primary snoring (without apnea).
Here’s a look at a study published in the:
Here’s some data from the 115 patients that completed the study:
- 65 patients had mild OSA
- 50 patients had primary snoring
- Watch Pat HST was the type of home sleep testing unit used before and after treatment
- 2 home sleep tests were performed pre-therapy, and 2 were performed after therapy
- The average AHI (apnea-hypopnea index) before treatment was just under 11 apnea-hypopnea events per hour
- The average reduction on AHI was a 52% reduction
- A 50% drop in oxygen desaturation resulted and a 4% drop in Epworth Sleepiness Scale (2% or more decrease is significant)
- Objectively 41% drop in the average amount of snoring per night
- Bed partner subjective feedback noted snoring decreased 39%
eXcite will be adding a snoring monitor app component to improve snoring feedback reports to physicians during treatments.
Additionally, trials are currently being conducted to review the effects of eXciteOSA® in moderate and severe OSA patients.
One study, in particular, is evaluating eXciteOSA® as an adjunct to CPAP therapy which may benefit therapy by reducing therapeutic pressure setting, which can then improve CPAP compliance for some individuals.
How much does eXciteOSA® cost?
The control unit cost may vary but averages about $800-900.
Also, consider that the detachable mouthpiece needs to be replaced every 90 days.
The cost for the mouthpiece averages $80-150. Also important to note that a new mouthpiece will need to be purchased on regular intervals.
Does insurance pay for it?
Although Signifier Medical Technologies is making progress in insurance reimbursement for eXciteOSA®, as of this point, eXcite therapy is not covered by medical insurance reimbursements and is an out-of-pocket expense.
Some patients may find the eXcite more affordable when using their FSA (Flexible Spending Account) or HSA (Health Savings Account).
Others may pay cash or use a payment plan like Care Credit. Most medical providers widely accept Care Credit.
Does the company offer a money-back guarantee for eXciteOSA®?
Interestingly, the company behind the eXciteOSA® offers a Customer Satisfaction Commitment. At this time, there was no particular end date to this commitment.
Here it is:
Can more than one person use an eXcite unit?
Although the mouthpiece is detachable from the base, only one person can use the device since the device will allow only one session a day.
Also, you can pair the device only individually with the app program, which guides treatment.
Do you need a prescription for eXcite?
Yes, eXciteOSA® is considered a medical device and a prescription is needed.
How can I obtain an eXciteOSA® day treatment device?
A patient may obtain a device in several ways:
The best place to start the eXcite discussion is with your sleep physician or sleep advanced practice provider. If they feel you are a good candidate, you can get set up with an eXcite one of several ways:
Path 1
Your sleep medical provider office may purchase units and dispense devices directly to you.
Path 2
Your sleep provider provides you with a prescription and refers you to a medical equipment supplier for purchase and dispensing.
Path 3
Your physician can fax a prescription directly to Signifier Medical.
The Signifier Medical company will contact you, answer more questions, and then direct you to a national medical equipment company that may mail the eXcite to you and help with set-up.
Signifer Technologies does not ship units directly to patients.
What if your sleep provider is unaware of eXcite?
Since eXciteOSA® is a new type of treatment for snoring and apnea, many sleep health care professionals have not yet had the experience of having in-depth knowledge of it.
Other medical providers may not fully support or be ready to prescribe it until they obtain more practical evidence of its value.
Interested in finding who in your area supports eXcite? Contact Signifier Medical directly through their contact form.
What can you expect after you receive an RX for eXcite?
Once a patient receives a prescription for eXcite, Signifier Medical will assign a patient advocacy team to the patient.
After the patient is set up with eXcite, a patient advocate touches base on days 1,5,10 and 21 and will serve as a liaison.
If there is ever a point that the patient misses 2 or more sessions, the advocate will reach out through emails and eventually a text message for added support.
On the corresponding app that guides the patient process, there is also a 24-hour chat feature.
The Pros and Cons of using eXciteOSA® for snoring and apnea treatment
Pros
- eXcite offers a relatively simple, and comfortable option
- Research shows positive effects for primary snoring, mild and moderate OSA patients
- It can be used for edentulous patients (denture wearers/no teeth)
- A company commitment offers the return of fees for several weeks after obtaining if not satisfied
- It can be used during the day while not interfering with added sleep discomforts or nuances
- The Signifier company offers a patient advocate to help through the process taking time off the medical providers for compliance monitoring and troubleshooting
Cons
- Treatment is not reimbursed by medical insurance currently, so that that cost may be an issue for some
- Time would need to be carved out to use the device daily for 6 weeks, then 2 times weekly after that indefinitely
Summary Points
It will be interesting to see where the eXciteOSA® daytime treatment option rests in helping snoring and apnea patients find relief.
Although currently, eXciteOSA® seems to be of value for primary snoring and mild apnea patients, I look forward to learning more about its role as an adjunct therapy to improve PAP (Positive Airway Pressure) and oral appliance treatments as well.
IMPORTANT
These helpful resources are general in nature and for educational purposes only. Please consult with your sleep health provider before starting any treatment option for snoring and apnea.
Resources
Baptista, P. M., Martínez Ruiz de Apodaca, P., Carrasco, M., Fernandez, S., Wong, P. Y., Zhang, H., Hassaan, A., & Kotecha, B. (2021, April 27). Daytime neuromuscular electrical therapy of tongue muscles in improving snoring in individuals with primary snoring and mild obstructive sleep apnea. Journal of clinical medicine. Retrieved February 28, 2022, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8123870/
A;, K. B. W. P. Y. Z. H. H. (n.d.). A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep & breathing = Schlaf & Atmung. Retrieved February 28, 2022, from https://pubmed.ncbi.nlm.nih.gov/33772397/
Aarab G;Lobbezoo F;Heymans MW;Hamburger HL;Naeije M; (n.d.). Long-term follow-up of a randomized controlled trial of Oral Appliance Therapy in obstructive sleep apnea. Respiration; international review of thoracic diseases. Retrieved February 28, 2022, from https://pubmed.ncbi.nlm.nih.gov/21454959/
Photos courtesy of eXcite OSA
