A little nerve stimulation can coax the tongue from blocking the airway and alleviate obstructive sleep apnea for a segment of sufferers who aren’t getting relief from continuous positive airway pressure (CPAP).

This is the mechanism behind a U.S. Food and Drug Administration (FDA)-approved technology that’s been known on the market as Inspire since 2014. It’s an implanted pulse generator surgically placed in the chest below the collarbone and comes with an external remote that allows users to activate it before going to sleep and turn it off when they wake.

“It’s a very good option for last resort—people who have tried everything,” author and former surgeon Dr. Steven Park told The Epoch Times. “But I wouldn’t put all your hopes and dreams on this technology.”

Obstructive sleep apnea (OSA) is a breathing disorder of apneas—cessation of breathing—that’s largely undiagnosed and untreated. According to the International Journal of Environmental Research and Public Health paper, it is quantified by episodes on an apnea-hypopnea index (AHI) that measures the number of events per hour. An AHI of five, with apneas lasting 10 seconds or longer, can lead to sleep fragmentation and hypoxia, a reduction of oxygen in the bloodstream.

Ideally, all options should be exhausted before surgery—a rarity for overwhelmed doctors and patients who are desperate for a good night’s sleep. Park, author of the Amazon bestseller “Sleep Interrupted,” explained that surgeons perform surgery, sleep doctors offer CPAP, and dentists provide oral appliances.

Those untethered subspecialties can cause fractured care for frustrated, sleep-deprived patients who are tempted to rush important medical decisions and are prone to prematurely forfeiting treatment plans.

“Ultimately, it’s hard to put the onus on the patients because they can be overwhelmed by all these options,” Park said.

Park said these results are statistically significant, but not perfect, illustrating the complexities of sleep apnea that must often be tackled with a combination of therapies. He was involved in research on a similar device in 2012 for a competitor of Inspire; that company ended up folding.

He also argued that even though the mechanism involved is aimed at tongue obstruction, it also can open up the palate significantly due to contraction of the tongue. In that way, the implant theoretically could resolve multiple obstructions.

One complication, however, is that it becomes less effective in more overweight patients. In fact, the 2018 study showed that for each one-point increase in BMI, the odds of surgery success fell by 9 percent. Surgeons who perform the procedure on mismatched patients are likely contributing to dissatisfaction rates.

Effectiveness and Risks of Inspire

How well Inspire works is also tied to settings on the device itself. The surgical site has to heal before doctors can turn on the generator and configure settings for each patient’s therapeutic range of treatment.

Oftentimes when there are problems, patients must be proactive to get them solved. In some cases, a follow-up procedure like an endoscopy or second surgery could be necessary to reset electrical configurations or repair other mechanical issues.

In its FDA application, Inspire noted side effects such as discomfort due to electrical stimulation, tongue abrasion, mouth dryness, functional issues with the device or the external remote, and pain associated with the presence of the device. There was a 1 percent chance of infection, and an 11 percent chance of acute symptoms such as coughing, choking, headache, and dysphasia. At the 18-month follow-up, 75 percent of device-related events were resolved. And despite the complications, compliance was at 85 percent.

Patients should be aware of the realities involved with an implanted device, including batteries that must be replaced every seven to 10 years and leads that could break or migrate inside the body or possibly remain in the body permanently even if the device is removed.

None of this is convincing for Sazama, who admits his bias for CPAP but also says he’s willing to be proven wrong. He has accepted sponsorships from CPAP manufacturers—though he complains openly about products—but he believes it’s still the most effective therapy that doesn’t offer the chance of harm to patients.

Sazama is not deterred. He’s resolved to help CPAP users overcome common issues that move them into compliance. He offers free advice online, as well as consultations, and he’s insistent that most issues can be resolved. The machines can be set to the wrong pressure, hoses can have leaks, and masks can have fitting issues.

Additionally, the machines can be problematic. Sazama said it’s not uncommon for them to record artificially low AHI reports. Patients will tell their doctors how awful they feel after sleep, but if the numbers are low, their concerns are likely to be brushed off.

“That’s horrible,” he said. “The data that those machines record are full of false positives and false negatives.”

Park said the biggest risk factor for apnea is obesity, which also creates vulnerability to several illnesses, such as COVID-19, and diseases like stroke, diabetes, and cardiovascular disease.

Even adopting better lifestyle habits, he said, can improve sleep. That includes eating more real food, getting sunlight exposure daily, preventing stress, limiting screen usage before bed, and stopping snacking after dinner.

“You don’t have to exercise like crazy to lose weight,” Park said. “They’ve shown exercise doesn’t do much to lose weight. It’s what you eat that’s most important. Look at everything in your life first if you want to treat your sleep apnea effectively.”

“I do mention these other options to everybody. It’s there. It’s published in mainstream literature, but doctors generally don’t practice it in their patients,” Park said.