Trouble sleeping? Austin sleep apnea trial could help transform lives and treatment options
AUSTIN (KXAN) – For years, Michelle Strickland had trouble sleeping – she woke up several times at night, 9 to 15 times and hour – and it left her with daytime sleepiness and her body craving lots of naps. Strickland recently went to the doctor after her father was diagnosed with sleep apnea. Sleep apnea happens when a person’s airway collapses, partially or completely, several times throughout the night, according to the American Medical Association.
“I would stop breathing about nine to 15 times a night,” Strickland said about what her sleep apnea test results revealed. “I did not want to be on a sleep machine. I had seen my dad be on a sleep machine, and that wasn’t going to be anything that I wanted.”
Strickland’s doctor suggested she join a study trial in Austin researching an alternative to using a CPAP, a continuous positive airway pressure machine, like the device her dad uses. Slow Wave is a fitted mouth guard made from a 3D scan of your teeth. Wayne Wagner, the man behind this alternative option, was diagnosed with the condition 20 years ago. He says his doctor offered several treatments, but Wagner says CPAPs or mouthguards didn’t work for him.
“He basically exhausted all the options he had, and said about the only thing you could do is develop a better product for yourself,” Wagner said.
Wagner went straight to work and designed his own products – back then it was all handmade – today the products are made through 3D printing and manufactured west of Austin in Spicewood.
“Our product is not sent overseas to be designed or manufactured. We design and print on-site,” Wagner said, CEO and inventor of Slow Wave.
Wagner is working with Austin Heart Clinic to find people to participate in the study that will play a major role in the cost. Slow Wave is already out in the market, and it costs $3,600, according to Wagner, but people in the trial are going to help health insurance companies tackle the cost.
“They can’t just take our word for it, and so that’s the main reason we’re doing a clinical trial, is so that we can get insurance coverage for everybody,” Wagner said. “We believe that insurance will cover it, hopefully including Medicare and Medicaid and the Veterans Administration.”
Currently you can find a variety of similar products, but Wagner says his product stands out because of a special design.
“We make more room for the tongue, and the tongue will naturally migrate into the space provided, as opposed to the other guys that try to pull the jaw forward,” Wagner said as he explained how the mouthpiece works. “What we do is we provide an enhanced tongue resting spot for the tongue to rest on at night, so that it doesn’t fall back in your throat and block the airway.”
Right now, 13 people in the Austin area are testing out Slow Wave, according to Angela Dela Llana, clinical research coordinator at Austin Heart, but the goal is to have at least 90 participants. After the study, people get to keep the mouthguard.
“It could give people access to treatments that they otherwise wouldn’t be able to get their hands on,” Dela Llana said.
The trial takes 90 days and once people are diagnosed with sleep apnea they are fitted with their own mouthguards. Besides keeping the mouthpiece participants also get a $100 Visa gift card for completing the study. The study is for adults between 18 and 70 years old.
“A lot of people are going untreated with sleep apnea because they’re not tolerating the current treatments that are out there,” Dela Llana said.
30 million people have sleep apnea but only 6 million are diagnosed according to the AMA, and the association says more people are developing the condition.
“This hasn’t improved with the pandemic either with many people experiencing less sleep because of altered life and work routines as well as higher stress levels,” the AMA wrote in a blog. “And with long COVID further exacerbating underlying conditions such as obstructive sleep apnea, it is important for patients to understand what is at stake.”
Wagner and Llana said people are seeing significant results just days after using it.
“One participant noticed a difference within the first couple days and reported better sleep,” Llana said, “but it is different from person to person because not everyone is used to sleeping with something in their mouth.”
There are health complications for people who leave sleep apnea untreated. The lack of oxygen can lead to heart attacks and strokes.
Strickland understands the urgency to get treatment and to take part in this trial. She says there is a history of heart disease in her family – including heart attacks, widowmakers, and more.
“It’s a little scary, I don’t want sleep apnea to play even a small hand in that,” Strickland said. “With Slow Wave, being able to help me control that, I feel more confident that I can hopefully skirt some of the cardiac issues that would come because of the sleep apnea.”
Click here to find out more about the criteria and if you are interested in being part of the study you can email ahresearch@hcahealthcare.com
