Dr. David Kent, Director of Sleep Surgery at the Vanderbilt University Medical Center, talks about how Genio can improve sleep better than a CPAP machine.
Interview conducted by Ivanhoe Broadcast News in 2023.
What is a Genio and how does it work? Can you explain that?
Kent: One of the things that I offer to patients is various surgical treatments for sleep apnea. One of the treatments that is under clinical trial right now is a product called the Genio device that’s made by a company called Nyxoah. The Genio implant is a hypoglossal nerve stimulator implant. We’re providing a gentle pulse to the tongue nerves while a patient is asleep overnight to help open up the airway by moving the tongue forward to unblock the airway help keep their throat from blocking up and help potentially keep them from snoring as well.
Why do so many people have sleep apnea?
Kent: Sleep apnea is a uniquely human condition. There are various aspects of our anatomy because of the way that we’re built for standing upright, and because of evolutionary changes in speech and swallowing, that make us very prone to developing sleep apnea. Not the least of which is that we sleep on our backs, unlike every other animal that you might have in your house at home. That by itself also makes our airways more vulnerable to collapse. Sleep apnea is also related to body weight. As the population has gained weight over the last century or two, sleep apnea has become increasingly prevalent as well. But a high body weight is not required for sleep apnea, and probably somewhere between 30 to 50 percent of people that have it aren’t overweight.
How does Genio compare it to Inspire?
Kent: The Genio device is a little different from existing treatments that we have existing implantable treatments that we have for sleep apnea in a few ways. One is that instead of going on one nerve to the tongue, it goes on both nerves to the tongue. The thinking is that if one nerve is good, two are better. That’s one of the things that this clinical trial is trying to evaluate. There also isn’t an implanted power source. The Inspire Device goes in through two incisions. The Genio is implanted through one incision, under the chin, and there’s no implanted power source. That means that there are no battery changes down the road in the future, but a power source, a small battery must be applied from the outside at night because the device doesn’t have the power on the inside on its own.
Why can some people only use a CPAP? Why is that their only option?
Kent: We have various medical and surgical treatments for sleep apnea. The main treatment option is what’s called a CPAP machine. A CPAP machine is just a small mask that’s connected to a machine that applies air pressure to the nose. If the throat is collapsing at night, that extra air pressure helps to keep the airway open. CPAP is still probably one of the most effective treatments, if not the most effective treatment that we have for sleep apnea because it doesn’t matter what part of the throat is collapsing at night, it helps to keep everything open. Now for some people, CPAP is the only immediate option that is available, because as body weight goes up, the throat gets increasingly collapsible at night. It can become so collapsible that nothing else will help to keep it open besides a CPAP machine or significant weight loss.
For claustrophobics, how can CPAP help?
Kent: Well, claustrophobia is one of the main reasons that people struggle to wear a CPAP machine. Now, there are many ways to mitigate or deal with a claustrophobia problem, and what it really comes down to is listening to the patient and listening to what their struggles are and then finding ways to work around that. Sometimes it’s just changing to a different mask that doesn’t make a patient claustrophobic. For instance, sometimes a small mask under the nose is a lot more comfortable or tolerable for someone than a mask that covers the nose and mouth. Sometimes it is just practicing with a mask at home, sitting in front of the evening news, wearing a mask for a few minutes, instead of trying to immediately go to sleep with it. Once you acclimate to it, it’s less of a challenge to be able to fall asleep with one.
How much does it cost and how is it implanted?
Kent: The Genio device is under clinical trial right now, which means that it’s not something that’s covered by insurance and there’s no cost involved for patients who are part of that clinical trial. It is implanted under general anesthesia in the operating room so there’s a single incision to put it in. Patients are asleep while that’s ongoing and they wake up afterwards and go home.
Compare everything that a CPAP brings with it to a simple implant like this.
Kent: CPAP machines are the most effective treatment that we have for sleep apnea because they deal with any part of the airway that’s collapsing. That’s the great part about them. The tough part about them, for some patients, is that it does require a change in your lifestyle. You must put a mask on when you go to sleep. You must be intentional about going to sleep. Some patients find it difficult to wear that mask all night because air can leak on them, or they feel constrained in their movement, or just maintaining the machine can be a challenge. The really nice thing about some of these implantable therapies is that there’s nothing on the mask or blowing air into the face, but those implantable treatments that we have also can’t treat just any part of the airway that’s collapsing. Part of the art of getting these treatments correct, whether it’s the Inspire device or Genio device or other surgeries that we do is making sure that we’re picking the right therapy for the right patient.
How did your patients do?
Kent: The patients that we have in the trial overall, are doing very well. I’ve been very pleased to see the results that we have here. The trial is still ongoing so we can’t share that data yet, but I’m going to be excited to see it come out when it’s done.
Is there anything that I missed or left out or any other things you wanted to speak on?
Kent: No, that’s the main stuff about Genio. I suppose I would say that it’s an exciting time to be in the sleep surgery field. I think that there’s a lot of innovation happening in this space and that in the next three to five years, we’ll probably see even new or more advanced therapies that could potentially be even more effective for people or that can reach an even larger portion of the population that have trouble using a CPAP machine.
Is there anything you can tell us about the patient? Do you remember who it was that you gave it?
Kent: Paula.
Can you tell us about how she’s doing or what her condition was?
Kent: When Paula first heard about the Genio trial and came to talk to us, she was really struggling. She was struggling to get benefits from a CPAP machine and to sleep comfortably with it. Her family was upset about her snoring and her sleep quality wasn’t very good and she’s really done wonderfully. She’s sleeping much better, and the family doesn’t complain about her snoring at all anymore. She reports having good energy during the day, and so I’ve been excited to see how well she’s done.
END OF INTERVIEW
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