The Snoozeal device can be powered by a remote control or smartphone app to make the tongue get exercise to prevent snoring and mild to moderate sleep apnea.
What happens when the gold standard in treating a condition is also one that patients either never get on or abandon after a few months?
That’s the paradox that faces doctors who want to prescribe CPAP (continuous positive airway pressure) masks to patients with obstructive sleep apnea. The device has historically low adherence rates with patients finding the masks and the tubes too cumbersome and intrusive to use during sleep.
Now a London, U.K.-based company is trying to take a stab at the root causes of snoring and OSA — weak tongue muscle — while also letting patients sleep without wearing a night time device.
Snoozeal has developed a hand-held device capable of providing a workout to the tongue to strengthen that muscle through mild electric pulses, or neuromodulation. The remote-controlled device can also be powered by a companion wireless app, which can record sleep quality at night. When the app controls the device instead of the remote control, it can provide insight into how often it is being used – a sort of activity tracker but for the tongue. The device was created by Dr. Anshul Sama, who has an interest in sleep disordered breathing.
In obstructive sleep apnea, breathing starts and stops repeatedly during sleep because the muscles of the throat fail to keep the airway open even though person who is asleep is trying to breathe. CPAP masks provide force air into the mouth to prevent the blockage of the airway. But compliance has been low.
The issue of compliance has flummoxed the field of obstructive sleep apnea, and the CEO of Snoozeal believes it’s here that his company’s device will make its mark.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“Our product is to be worn during the daytime so the compliance rate is going to be 100 times more than a product that is a night time product,” declared Akhil Tripathi, the company’s cofounder in a recent phone interview.
Specifically, the device, which has CE Mark, is to be worn daily for 20 min as the tongue receives the electric pulses, to prevent its collapse to the back of the throat. The person, who suffers from snoring or mild sleep apnea can then go to bed without anything external encumbrance.
Snoozeal is currently conducting a clinical trial to enroll patients — the goal is to enroll about 120. The patients are recruited after going through a sleep study and some wear CPAP masks, others may not of trial participants, Tripathi said.
Preliminary results will be obtained in March but full results will be published in the second quarter of next year. So how can the success of the trial be measured?
If partners report less snoring then that provides a clue to how the device is functioning, Tripathi said of these subjective results. But the company is not simply relying on partner-reported outcomes. It will conduct sleep studies on an ongoing basis. Finally, for CPAP users who are trying on the Snoozeal device as an aide, measuring the amount of water used over a period of time can reveal the device’s efficacy. Water is needed by the CPAP machines to create the pressure that keeps the airway open.
“The way we are studying is the amount of water used over a period of time,” Tripathi said. “The less the water used, the better the sleep apnea is getting.”
Snoozeal has raised about 2.3 million pounds ($2.8 million) from individual investors, friends and family and is on the hunt for 5 million pounds ($6.2 million) to commercialize the product. The company is also looking for manufacturring partners. To enter the U.S. market, the company will need regulatory clearance and a pre-submission meeting with the FDA has been scheduled early next year.
The company’s website doesn’t mention Tripathi and bills the device more as an anti-snoring device than a sleep apnea product. This is likely a smart move, given that it would be hard for Snoozeal claim efficacy on a new device without published data on OSA, which is a clinical condition unlike snoring.
As Snoozeal ramps up, there appears to be external evidence of the link between tongue exercises and improved snoring. A small Brazilian study of 39 patients tested the “effects of oropharyngeal exercises on snoring in minimally symptomatic patients with a primary complaint of snoring and diagnosis of primary snoring or mild to moderate OSA.” The conclusion was that these exercises can reduce “objectively measured snoring and are a possible treatment of a large population suffering from snoring.”
Aside from Snoozeal, which Tripathi declared to be the only product to target the root cause of snoring and OSA instead of others that are just managing symptoms, there are other companies reimagining the CPAP mask treatment.
There’s Inspire Medical Systems, which uses neurmodulation to stimualte the hypoglossal nerve that controls the tongue but using an FDA-approved implanted device. The patient can turn on the implanted device by a remote control before he or she goes to sleep. In November, the Minneapolis company announced that it had completed the 1,000 implant since the approval in April 2014. It also announced it has raised $37.5 million in a Series F financing round.
A twist on this same theme of using an implanted device to manage OSA is the solution that ImThera Medical of San Diego has dreamed up. Unlike Inspire Medical that only stimulates the hypoglossal nerve, ImThera’s device stimulates multiple areas of the tongue. However, that company has not yet won FDA approval.
There’s also WINX, a prescription device from Redwood City, California-based ApniCure. It is a mouthpiece that delivers light negative pressure to keep the airway open during sleep by drawing the “soft palate forward and stabilizing the tongue,” according to the company’s website.
It’s no surprise that so many companies are keen to solve the problem of obstructive sleep apnea. An August report from Grand View Research predicted that the global sleep apnea device market will be worth $7.9 billion by 2022.
Photo: Snoozeal
