The Science Behind SinuSonic
Science-backed Clinically Supported Nasal Relief
What makes SinuSonic unique is that it is not a drug. It’s not a spray. It’s not an irrigation device.
Most of the current treatments for nasal congestion and rhinitis are drugs that must be ingested into the body on a regular basis. These include various nasal sprays (decongestants or steroids), pills (decongestants and antihistamines) or uncomfortable nasal irrigators, each of which has its own side effects and risks. SinuSonic delivers acoustic vibration and gentle pressure, harnessing the body’s own mechanisms in order to open nasal passages naturally.
SinuSonics design is based on our extensive research of the therapeutic effects of positive expiratory pressure (PEP) and vibration on airway functionality and mucous movement in chronic lung conditions. Although the SinuSonic device combines PEP and vibration differently than existing devices, we’re confident that it will aid in upper airway functionality and mucous movement, similar to the proven therapeutic effects for lower airway congestion.
Our confidence is based on a 2008 systematic review by Hristara-Papadopoulou and colleagues found that most of the existing devices that combine PEP and vibration lead to a statistically significant increase in lung volumes, ciliary motility, and sputum production for those with cystic fibrosis. Our most recent clinical trial also supports the success of SinuSonic.
Further rationale for incorporating acoustic vibration is based on research suggesting that human humming improves sinonasal patency via increases in nitric oxide, a natural smooth muscle relaxant created biologically, that has anti-inflammatory and antimicrobial/fungal/viral properties.
Nasal Congestion's Impact
Limitations of Current Options
The four pairs of air-filled paranasal sinuses have an anatomically unfavorable position in that they lie in proximity to the nasal cavity which is heavily colonized by bacteria, viruses, mold, and other environmental pathogens.4
Inflammation of the nasal mucosa can cause obstruction of the ostia, the small openings that connect the sinuses and nasal cavity, causing poor sinus ventilation, inadequate drainage, discomfort, and even infection.5
A myriad of products exist to manage the symptoms of nasal congestion including pain relievers and anti-inflammatories, decongestants, antihistamines, and nasal irrigation. However, these treatments are limited in that they provide only partial and/or temporary relief and sometimes have untoward side-effects.
For example, it is well-established that use of nasal spray decongestants, such as oxymetazoline, can lead to a phenomenon known as rebound congestion or nasal spray dependence6.
Additionally, systemic decongestant agents, such as pseudoephedrine, have been shown to increase blood pressure and are associated with dependency (DEA Title VII of Public Law 109-177).7
Given the limitations of current treatment options for nasal congestion, there is need for novel non-pharmacologic therapies, ideally ones that target the unique anatomy of the sinus system.
The SinuSonic is a novel self-applied nasal device designed to reduce nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure. The SinuSonic consists of a fully disposable medical grade silicone nosepiece mounted to a resin body. The device is equipped with a flutter valve located at the top of the device which creates gentle, self-guided oscillating expiratory resistance. Acoustic vibration is emitted via a single circuit board speaker at the base of the device at approximately 128Hz8.
The fundamental underpinnings of the device’s design are based on research substantiating the therapeutic effects of positive expiratory pressure (PEP) and vibration on airway patency and mucous movement in chronic lung conditions. Although the SinuSonic device combines PEP and vibration differently than devices used for lung conditions (i.e. by adding acoustic and mechanical vibration to PEP), it is hypothesized that utilization of the aforementioned techniques will aid in upper airway patency and mucous movement, similar to the proven therapeutic effects for lower airway congestion. For example, a 2008 systematic review by Hristara-Papadopoulou and colleagues found that most of the devices that combine PEP and vibration produce statistically significant increase in lung volumes, ciliary motility, and sputum production for those with cystic fibrosis.9 The rationale for incorporating acoustic vibration is based on research suggesting that human humming improves sinonasal patency via increases in nitric oxide,4,10-12 a smooth muscle relaxant that has anti-inflammatory and antimicrobial/fungal/viral properties.13
Big clinical trial with two important goals
Our latest clinical trial was conducted with two simple goals in mind, guaranteeing the safety and effectiveness of our SinuSonic device. Based on how the device works, we really had very little concerns regarding safety. However, it’s important to make sure the device truly is safe in the real world. Therefore, we asked patients about pain/discomfort, bleeding, and crusting. We also performed rhinoscopy, which means we visually looked into people’s noses to make sure the mucosal lining all looked normal after use.
Next, we sought to prove SinuSonic was an effective solution to nasal discomfort. We measured PNIF, which stands for “Peak Nasal Inspiratory Flow.” Basically, PNIF is a measure of how much air somebody can breathe in through their nose. People who are stuffy or congested tend to have lower PNIF scores. People with really open noses will have higher PNIF scores. Although PNIF is a great measure of nasal airflow, we didn’t want to stop there.
We also wanted to ensure that SinuSonic could actually improve our patients’ overall quality of life. To do this, we used a variety of measurements to calculate each patients quality of life. We compared quality of life scores before and after SinuSonic use to determine if there was any change.
What did we find?
We found that PNIF --- (Peak Nasal Inspiratory Flow) scores increased by 15% after just three minutes and 30% after two weeks of twice-daily treatments.
This is a pretty dramatic increase in airflow that was statistically and clinically significant. Basically, this was similar to what you might experience by using a decongestant spray, but without all of the problems that these sprays cause with chronic use. In fact, this improvement was not that different from what some patients experience with surgical procedures to improve airflow.
We also found dramatic and significant improvements in nasal congestion, facial pressure, and nasal drainage. Results also pointed to dramatic and significant improvements in quality of life using two different surveys, the NOSE score and the SNOT-22 score.
Why are these findings important?
What this means is that not only does airflow improve after using SinuSonic, but patients also actually feel significantly better, and most importantly their quality of life is significantly better.
To the average person without nasal or sinus problems, it might seem weird that a device that improves nasal congestion could actually improve someone’s quality of life. However, chronic nasal or sinus congestion can really interfere with someone’s quality of life and their ability to function; so we now that a treatment that can reduce these symptoms can have a huge positive impact.
NOSE score results
NOSE stands for the “Nasal Obstruction and Septoplasty Effectiveness” scale. The NOSE score is calculated using a validated questionnaire that consists of five questions related to a patient’s nasal congestion over the last month. Each question is scored from 0-4. The total score is multiplied by 5 and can range from 0-100, with 0 being the best and 100 being the worst. The NOSE scale is usually used to determine how much improvement a patient experiences after undergoing surgical procedures to treat nasal congestion. This instrument really captures how badly nasal congestion impacts a patient. In this study, NOSE scores improved significantly after using the SinuSonic device. In fact, the NOSE score improved by 27.1 points after five weeks, which was statistically and clinically significant.
SNOT-22 Score Results
SNOT-22 stands for the “22-item Sinonasal Outcome Test.” Essentially, this is a set of 22 questions that ask patients about various symptoms such as nasal congestion, facial pressure, nasal drainage, etc. and how these impact their quality of life.
Each question is scored from 0-5 and combined for a total score from 0-110. The higher the score, the lower their quality of life. The SNOT-22 score is currently the most widely utilized quality of life instrument for studying outcomes for patients with chronic sinusitis. In this study, the SNOT-22 score improved an average of 17.5 points after five weeks, which was statistically and clinically significant.
VAS Score Results
VAS stands for “Visual Analog Scale.” Most people are familiar with these types of scales, which ask patients to rate their symptoms ranging from 0-10, with 10 being the worst and 0 the best. In this study, patients started with a baseline average of 5.8. After using SinuSonic for five weeks, these scores decreased to 2.6, which was statistically and clinically significant.
PNIF stands for “Peak Nasal Inspiratory Flow.” PNIF is a measure of how much air somebody can breathe in through their nose. This is recorded in liters per minute (L/min). People who are stuffy or congested tend to have lower PNIF scores. Those whose nose is more open will have higher scores. After three minutes of SinuSonic use, PNIF scores increased from 79.5 L/min to 91.3 L/min. After two weeks of twice-daily usage, PNIF scores increased all the way to 104.5 L/min.
Why should this matter to you?
As you are aware, patients can find themselves on many different medications these days. Don’t get me wrong, medications are incredibly important. But they can also have notable costs, side effects, and interactions. This is particularly important for a chronic condition, where a patient might have to use the medication for years at a time. A lot of people are looking for ways to reduce the number of medications they take. They are paying more and more attention to what they are putting into their bodies. Whether you’re interested in reducing the medications you take, avoiding costly surgeries, or saving money, SinuSonic is your solution.
How does SinuSonic work?
When scientists study medical devices, the first step is usually to determine if a device actually works to treat medical conditions. This step was completed and clinical benefit was confirmed in the study conducted at the Medical University of South Carolina. Researchers then try to figure out how a device actually works. This is called the mechanism of action. Understanding the mechanisms of action for SinuSonic will help guide future studies. It may also impact recommendations for use of SinuSonic in other medical disorders or optimal duration of use for nasal congestion. SinuSonic simultaneously delivers both acoustic vibration and oscillating expiratory air pressure. There are very compelling and logical reasons for combining these two modalities, as each has been shown to have therapeutic benefit in past studies.
Much of the prior research examining acoustic vibration in the airways has focused upon nitric oxide (NO) as a potential mechanism of action. NO is a gaseous molecule that has a wide variety of actions. It is anti-inflammatory, anti-bacterial, anti-viral and anti-fungal and has even been shown to block inflammatory pain14,15. NO also stimulates mucus production and ciliary beating which are the hairlike structures that line the airway16. These actions improve clearance of airway mucus. The vast majority of NO is produced in the sinuses and is slowly released into the nasal airway. Acoustic vibrations, such as humming, have been shown to dramatically increase nasal NO levels. One study determined that optimal NO release occurs with acoustic vibrations around 120-130Hz17. For this reason, SinuSonic was designed to deliver acoustic energy at 128 Hz. Preliminary studies suggest peak nasal NO levels more than double within seconds of using SinuSonic.
After identifying possible mechanisms of action, researchers then conduct studies to determine if these mechanisms may play a role in certain diseases and if targeting these mechanisms may identify new therapies. One such study performed at the Mayo Clinic found that patients with chronic sinusitis who had lower levels of nasal NO had more severe sinus symptoms18. Given the anti-inflammatory and anti-bacterial properties of NO, this logically leads to the question of whether or not supplementing NO or increasing the body’s production of NO may serve as a new therapy for these patients. Researchers in Australia are conducting some of these novel studies19.
In addition to acoustic energy, SinuSonic also delivers positive expiratory pressure (PEP). This occurs via a flutter valve located at the top of the device which creates gentle, self-guided oscillating expiratory resistance. PEP has been used in pulmonary diseases for years and has been shown to improve lung function and remove secretions20.
The fundamental underpinnings of SinuSonic’s design are based on research substantiating the therapeutic effects of combining positive expiratory pressure (PEP) and vibration in chronic lung conditions. For example, a 2008 systematic review found that most of the devices that combine PEP and vibration produce statistically significant increase in lung volumes, ciliary motility, and sputum production21. Although the SinuSonic device combines PEP and vibration differently than devices used for lung conditions (i.e. by adding acoustic and mechanical vibration to PEP), it is hypothesized that utilization of the aforementioned techniques will aid in upper airway congestion and mucus movement, similar to the proven therapeutic effects for lower airway congestion.
In addition to the beneficial effects of acoustic energy and positive air pressure independently, combining these two modalities leads to improved delivery of medications to the sinus cavities22. Whether or not this results in clinical improvement is an area for further study, but numerous novel therapies for sinusitis are targeting improved drug delivery23.
The above potential mechanisms of action are hypothetical at this point. There are a number of other possible mechanisms that could play a role. These include impacting numerous neurotransmitters and inflammatory molecules in the airway, stimulating neural reflexes, impacting pressure and temperature sensors in the nasal mucosa, altering pain receptors and improving gas exchange throughout the upper airway. It is likely that many of these mechanisms overlap and impact each other.
The team at SinuSonic is actively investigating mechanisms of action and the potential use of SinuSonic for other conditions. Eustachian tube dysfunction occurs when air pressure in the middle ear does not equalize with the air pressure in back of the nose. Current treatments include Valsalva maneuver (positive air pressure to “pop” the ear), balloon dilation of the Eustachian tube or placement of pressure equalizing ear tubes in the ear drum. If SinuSonic is able to improve gas exchange through the Eustachian tube, this may provide patients with a non-surgical treatment. Similarly, many patients suffer from sinus pain and pressure, but have no evidence of sinusitis. Thus treatments with antibiotics or sinus surgery are unlikely to be beneficial. If SinuSonic improves gas exchange across the sinuses and/or increases NO release, this may block pain signals in this region.
The science of studying new medical devices is always exciting. Patients and healthcare providers must carefully examine the evidence for any new device claiming to improve clinical symptoms and understand the rationale and mechanisms by which new devices may work.
Potential mechanisms of action and areas for further study
- Release of NO, intracellular calcium and other intracellular messengers
- Kills bacteria, virus and fungi
- Stimulates mucus production
- Increases ciliary beat frequency
- Block peripheral pain sensors
- Activates pressure or temperature nerve endings
- Stimulates neural reflexes
- Equalizes air/gas pressures between sinuses
- Alleviates positive or negative air pressure across Eustachian tube
- Improves drug delivery to sinuses