Inspire Sleep Apnea Device Review: No more CPAP?

For people who snore, a diagnosis of sleep apnea can be a big relief. The condition, which causes people to stop breathing repeatedly while sleeping, is linked to a higher risk of stroke, heart failure, and dementia over time—and can leave people exhausted during the day. Fortunately, the gold standard treatment is highly effective and generally covered at least in part by insurance.

But that treatment is not a simple pill. When people with sleep apnea snooze, soft tissue in the back of the throat collapses as their muscles relax, blocking the upper airway. The best fix for this is a continuous positive airway pressure (CPAP) machine. Using one involves sleeping next to a humming machine while wearing a mask that pumps air into your airway, keeping it open. “There’s a lot of stigma about using CPAP,” says Rafael Sepulveda, MD, a sleep and obesity medicine specialist in Sonoma, Calif.

There are a wide range of alternative treatments for obstructive sleep apnea (OSA) depending on the severity of the condition. But in recent years, one heavily marketed treatment known as Inspire, which debuted in 2014, has become more popular. The company’s annual revenue has soared from about $29 million in 2017 to $408 million in 2022.

Here’s what sleep medicine experts say about the Inspire implant and similar devices that may come on the market soon: how they compare with CPAP, whom they work well for, and who shouldn’t get one.

What Is Inspire?

Inspire is an implantable upper airway stimulation device that stabilizes a person’s throat during sleep in order to prevent obstruction of the airway. It is currently the only FDA-approved implant for OSA. (Another device is currently undergoing clinical trials.)

An illustration of how the implanted device works to open the airways. (Inspire Medical Systems)

The appeal of such a device is easy to see: pressing a button on a remote before falling asleep seems far less burdensome than turning on a machine and sleeping while wearing a mask. And doctors say that in patients who fit the eligibility criteria, these devices significantly improve sleep apnea symptoms.

But getting the Inspire involves a surgery, with a device that is likely to be implanted in someone’s body for the rest of their life. And sleep medicine experts say these should only be used in people who can’t use CPAP and who fit the eligibility criteria exactly. CPAP treatment is far less invasive, and if Inspire is not the right fit, it might not even help.

Ads for these devices—“No mask. No hose. Just sleep.”—can make it look like OSA can be solved with the click of a button on a remote. But it’s not that simple, says Dennis Abbott, 53, a resident of Austin, Texas, who has used Inspire for two years.

Abbott previously used CPAP for about a year and a half, and it worked well for his sleep apnea. But in his case, CPAP also led to a complication called aerophagia: a condition where people swallow air into their GI tract, which can cause significant discomfort. His otolaryngologist recommended he get checked out for the Inspire implant, and it turned out he fit the very specific qualifications that make someone a good fit for the device. (More on those below.)

Now, he says, he has adjusted well to the implant—and is even able to go on backpacking trips with it, something that’s not possible with a full CPAP setup. “It’s amazingly more convenient,” he says.

But a device like Inspire won’t work for everyone, and most people can find relief with a less invasive, nonsurgical option. Sleep experts like Sepulveda say that if you can treat OSA without invasive surgery, that’s the preferred option.

In general, most private insurance will cover Inspire only if a patient with at least moderate sleep apnea has tried to make CPAP work but has not been successful. Meeting the candidate criteria for the implant is also an important factor.

Treating Sleep Apnea

For milder cases of OSA, some people can find relief with oral appliances like a mouthguard that helps position the jaw, and lifestyle changes including weight loss and avoiding sleeping on their back.

But for most people with moderate to severe sleep OSA—defined as having 15 or more full or partial airway collapses, known as apnea and hypopnea events (AHI) per hour—the standard treatment is CPAP. “It’s highly effective, it has a good risk profile, and it’s noninvasive,” says Luu Pham, MD, an assistant professor of medicine at Johns Hopkins Medicine in Baltimore, who specializes in pulmonary, critical care, and sleep medicine. “The main thing is [getting used to] sleeping with it on your face.”

That can be a challenge. Three months after starting treatment, almost 30 percent of people don’t consistently use their CPAP, according to one 2020 study. That study also found high levels of variance depending on age and sex. Young women were much less likely to use their devices regularly than older men, for example.

Still, the image of the bulky, hard-to-use machine with a full-face mask is antiquated, Sepulveda says. That’s based on media portrayals as well as the notion that masks and CPAP devices are invasive and loud.

In fact, there are more than 100 subtypes of masks as well as adjustable settings in CPAP devices to help users achieve a comfortable and effective therapy. There are also similar machines, like a bilevel positive airway pressure machine (referred to as BPAP or BiPAP), that doctors can use in patients with poor tolerance or more complex breathing problems during sleep. Once setting adjustments and the right mask are found for a particular patient, most will tolerate it pretty well, Sepulveda says. (For more on finding a CPAP setup that works for you, see our previous coverage.)

If CPAP still isn’t working, there are also surgical options. Those that reshape the airway are most effective when there is an anatomical cause for OSA, though because of the inherent risks of surgery, they should still be considered only after trying CPAP, according to the American Academy of Sleep Medicine. If you are the right fit, you can also consider an implant like Inspire.

How Inspire Works

Inspire contains three components: a battery-powered pacemaker-like device implanted in the upper chest, a breathing sensor, and a cuff placed on the hypoglossal nerve, which controls the tongue. These components work together to move the tongue forward during sleep, to keep the airway open. The pacemaker-like component of the device is implanted under the skin and may be visible, depending on the patient; if so it looks like a slight bulge on the chest.

If doctors determine a patient is a good fit, a surgeon will install the system. The procedure itself takes about 2 hours and is done under general anesthesia. After surgery, the recovery period may be more intense than many expect. “Surgery was intense, the recovery was fairly painful,” Abbott says.

Doctors wait a month after installation before turning the device on the first time, giving the body some time to heal.

Who Is a Good Candidate for Inspire?

There are very specific qualifications required to make someone a good candidate for Inspire, Sepulveda says.

First, doctors need to be certain that the main problem for these patients is OSA, not central sleep apnea or something else, Pham says. Other sleep issues that could cause intolerance to CPAP, like insomnia or circadian rhythm disorder, need to be ruled out. Inspire is typically indicated for adults over 18 years old with moderate to severe sleep apnea and a body mass index of 32 or lower. Sepulveda says he also tends to lean toward more conservative treatment for anyone over 80.

Someone also needs to demonstrate poor tolerance or non-adherence to CPAP or similar devices: Most need to have tried another therapy like CPAP for at least three months to be considered a candidate, Sepulveda says.

Finally, a potential Inspire user will need to undergo a test called a drug induced sleep endoscopy, where they are put into a sleeplike state so a surgeon can evaluate what their throat looks like as it collapses. Certain types of collapses prevent someone from qualifying for one of these implants.

In Abbott’s case, he says that after using a CPAP for a year and a half and trying a variety of different settings, pressures, and masks, he was evaluated by an ear, nose, and throat surgeon before he qualified.

Caveats and Cautions

The reason for all of these qualifying factors is simple: “In patients who fit the eligibility requirements for Inspire, the device significantly improves sleep apnea symptoms,” Sepulveda says. For a good candidate who fits all the criteria, clinicians can achieve a reduction in sleep apnea that’s comparable to CPAP, he says. But Inspire is not an appropriate fix for everyone with sleep apnea.

Even though patients are typically screened fairly thoroughly, the probability of one of these implants working is not 100 percent, Pham says. In one Inspire-funded study, two-thirds of the participants who got the implant had sleep apnea events reduced by at least 50 percent at 12 months, with the typical sleep apnea score falling from the moderate into the mild range. But a third of participants did not see that level of improvement.

If it doesn’t work, people have to go back to other treatment methods. And when they do, doctors will still usually leave the Inspire device in to avoid damaging the nerve while removing it. For those reasons, doctors recommend making sure patients truly cannot tolerate CPAP before trying any surgical solution.

It’s also worth noting that Inspire has asked the Food and Drug Administration to make requirements for qualification less strict. The company has submitted a request to the FDA asking it to raise the BMI limit to 40 and the upper AHI score to 100. Inspire also told CR that it would like to remove the requirement for drug-induced sleep endoscopy for certain patients and provide alternative screening methods.

The procedure itself is generally well-tolerated, Pham says. But all surgery carries the risk of potential infection. One 2020 study looking at adverse events associated with Inspire between January 2014 and May 2020 identified 196 adverse events, including 50 infections, and 83 events that required re-operations—generally to remove the device or reposition it.

Living With Inspire

It typically takes a month to activate the device after implantation, and a couple of months for the clinician to find the optimal settings. Adjustments are based on patient feedback and data from the device, according to Sepulveda. In Abbott’s case, he says it took about nine months of adjusting different settings.

Every night you turn on the device before going to sleep with a small remote. You’ll feel a pulse, and then there is a delay—which is programmable, with a 30-minute default—to give you time to fall asleep before the stimulation kicks in. The stimulation itself feels like a tingling or a slight contraction in the tongue, according to the University of Kansas Health System. If you’re still awake at that point, you may want to restart the cycle. If you struggle with insomnia and go through this repeatedly, it can cause serious frustration, Abbott says.

And while he’s very happy with the convenience of the device, he says it’s not necessarily something he’d see as a vanity option for someone who just doesn’t like the look and feel of the CPAP machine. “There is a battery in your chest,” he says. As with CPAP, dry mouth is a common side effect for users, especially those who tend to breathe through their mouth.

It’s also important to know that once the device’s battery is running low, it needs to be replaced with an outpatient surgical procedure. Inspire says that the battery is designed to last between nine and 11 years—the exact amount of time may vary depending on use. In the meantime, Abbott says airport security hasn’t been an issue, at least going through a typical metal detector. And he is able to get an MRI if he needs to.

Today, he says that he has fully adjusted and that he enjoys the convenience of the device—he adds that the slight bulge from the implant doesn’t interfere with the straps of his hiking pack. But when people ask him about making the switch, he still recommends trying to work with a doctor to see if there’s a CPAP setting that works for them. If so, he says, “you should probably stick with that as long as you can.”

Problems With CPAP

There’s no denying that Inspire’s niche is the large number of patients who can’t seem to get CPAP to work for them.

Previously considered the gold standard of treatment for sleep apnea, CPAP only had a compliance rate of 34 percent, according to two decades of data presented in a 2016 review in the Journal of Otolaryngology–Head & Neck. The article reported that behavioral intervention did little to improve low compliance.

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.”

Another issue is Medicare’s reimbursement for education on CPAP usage is so low it ends up costing providers, and Sazama said many clinics stopped holding classes as a result. Insurance reimbursements are rarely enough to cover costs.

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