The SinuSonic has undergone and continues undergoing clinical research and trials to prove its effectiveness in helping relieve nasal and/or sinus congestion and stuffiness. To learn more about the research behind SinuSonic and ongoing research and clinical trials, read on below.
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
Current & Future Research
The SinuSonic was studied to quantify nasal congestion improvement as a result of using the SinuSonic in a controlled clinic setting. Overall, results were encouraging and supported the hypothesis that exposure to the SinuSonic would subjectively reduce nasal congestion and improve ease-of-breathing. Clinical and patient global impressions of change convergently validated findings from self-reported change on VAS scales. Additionally, statistical significance despite low statistical power suggested a moderate to large effect size of the device on symptom change. Results are generally consistent with the body of literature supporting vibration and PEP on lower airway mucous movement and airway patency.9 It is probable that this device provides acute relief from nasal congestion (and possibly relief from chronic nasal congestion) with substantial efficacy and minimal side effects.
A recent study examined patients with chronic nasal congestion. The SinuSonic demonstrated a clinical improvement in nasal congestion and airway conductivity. In other words, less stuffy and easier to breathe through the nose.
Future studies will address other issues including dose response and duration of effect as well as exploring mechanism of action. A larger trial is currently underway at a US News and World Report top-ranked Ear, Nose & Throat Hospital – this study is registered on ClinicalTrials.gov.
Hear more from SinuSonic co-founder, Dr. Richard Bogan as he discusses the nose and sinuses: