While tens of millions of people live with snoring or obstructive sleep apnea, the most commonly prescribed treatment – a CPAP mask – has historically low adherence rates. So London-based Snoozeal has developed a device that aims to eliminate the need for the cumbersome masks, tubes and noise associated with CPAP machines that make them so unpopular for users.
Snoozeal’s product, which has a CE Mark, approaches the problem of obstructive sleep apnea and snoring at the core – weak tongue muscles. During sleep apnea, the muscles of the throat aren’t able to keep the airway open, causing breathing to start and stops repeatedly throughout the night. So the handheld device serves as a tongue “workout” that people use for 20 minutes a day, delivering mild electric pulses (called neuromodulation).
“Our product is to be worn during the daytime so the compliance rate is going to be 100 times more than a night time product, “ Snoozeal cofounder Akhil Tripathi told MedCity news.
It can be used by remote control or a companion wireless app, which can also record sleep quality at night. The app also can give users and their doctors insight into how often it is used, serving as an activity tracker specific to the tongue.
Snoozeal is currently conducting a clinical trial to enroll patients who have already been through a sleep apnea study. The trial will be carried out on a few different methods – ongoing sleep studies based on data from the app, subjective reports from partners on how the device seems to be affecting their partner, and another for those who are using it to complement their CPAP. For the latter, the study will measure the amount of water used in CPAP machines over time, ostensibly showing how often they have to use the CPAP.
Snoozeal is aiming to enroll about 120 people, including those who wear sleep apnea masks, and expect to publish preliminary results in March and full results by the second quarter of 2017.
That being said, the company does bill the product more as an anti-snoring device on their website, likely to avoid the need to produce claim efficacy on the device for sleep apnea, which is a clinical condition.
The company has raised about $2.8 million (2.3 million British pounds) from individual investors and is looking to raise another $6.2 million (5 million British pounds) to commercialize the product. As they look towards the United States market, they are in the process of seeking regulatory clearance and reportedly have a pre-submission meeting with the FDA scheduled for early 2017.
