Snoring affects the quality of life of hundreds of millions of people and can lead to obstructive sleep apnea (OSA). Innovators have strived for decades to help these people, but many of the resulting products are cumbersome, must be used at night, and lack evidence of clinical efficacy. Now, SnooZeal has developed a device designed to address these limitations.
The potential market for such a device is significant. Mild OSA, which is characterized by the collapse of airways, is estimated to affect around one-fifth of adults. Sufferers may become tired, short of energy, and depressed. Snoring leads to similar, albeit milder, outcomes in people with the condition and their partners. With surveys estimating the prevalence of snoring to be as high as 50%, the condition is conservatively predicted to affect hundreds of millions of people.
This translates into a major market opportunity. One report predicted that the market for antisnoring devices and surgical procedures will grow from $16 billion in 2015 to almost $23 billion in 2024.
Attempts to treat the condition focus on improving a part of the airway. Snoring and OSA occur when muscles in the throat relax, causing tissues to collapse and block the airway. When there is a partial blockage, this results in vibrations that are responsible for the characteristic snoring sound. When the blockage leads to a loss of oxygen, the patient is classed as having OSA.
Attempts to address these conditions have driven the development of nasal sprays, nose clips, mandibular splints, pillows, and other prod-ucts designed to keep the airways open. However, while continuous positive airway pressure has established itself as the treatment for moderate to severe OSA, people with snoring and mild apnea lack clinically proven options.
Addressing the root cause
Anshul Sama, a consultant at the University of Nottingham, saw the need for better devices while treating people with sleep disordered breathing. This led Sama to invent a device to address the unmet needs of his patients.
Sama’s big idea was to use a tiny electrical cur-rent to stimulate muscles in the mouth and tongue. Many studies have shown that electrical stimulation improves muscle function. If muscles in the mouth responded in the same way, daytime stimulation could prevent excessive muscle relaxation at night, keeping the airway open and providing lasting relief to people with snoring and mild OSA.
This idea led to the creation of a three-component device (Fig. 1). The central component of the product is a soft silicon mouthpiece that fits onto the tongue. A rechargeable control unit connects to the mouth-piece and communicates with a remote control via Bluetooth. The patient uses the remote control to select the level of stimulation and program delivered by the mouthpiece.
Fig. 1 | The SnooZeal electronic sleeping device.
Sama went on to test the device in humans. In one study, 27 people with snoring or mild OSA used the device for 20 minutes twice a day for 6 weeks. Sama and his collaborators assessed the participants’ snoring using the visual analogue scale (VAS) before, during, and after treatment. VAS measures snoring severity on a scale from 0 (no snoring) to 10 (snor-ing severe enough to make people leave the room). The investigators also recorded sleep quality via the Pittsburgh Sleep Quality Index (PSQI).
Mean VAS fell from 6.4 to 3.1 over the course of the trial. Similarly sharp declines were seen in subgroups of participants with snoring or mild OSA. In practice, this means that the device improved the severity of snoring from moderate to severe to mild within 6 weeks. The trial also recorded a statistically signifi-cant improvement in global PSQI score.
Adding connectivity and AI
The data suggest Sama’s SnooZeal device is a clini-cally proven, over-the-counter daytime treatment for snoring and mild OSA. This already sets SnooZeal apart from the competition, and the company is working on features to further improve its product.
The first-generation device features some con-nected, smart features, such as the ability to con-trol the stimulation it emits via a smartphone app. Researchers at SnooZeal are now working on a sec-ond version of the device that takes the idea to the next level. The big advance is the incorporation of a biosensor into the mouthpiece.
SnooZeal’s sensor connects to a database and to associated machine-learning algorithms to rec-ommend treatments tailored to the needs of each patient. The system enables SnooZeal to manage treatment time expectations, provide feedback on tongue muscle tone, and predict the probability of OSA.
These features build on the validated core concept behind SnooZeal. This concept stands to improve on the limited relief provided by existing night time treatments of snoring and OSA by addressing the underlying cause of the condition during the day. The result is that people now, for the first time, have access to lasting effective relief without the need for a night time device or treatment. SnooZeal is now seeking strategic partners worldwide for potential sales and distribution of the product.
Richard Kent, COO