Inspire device for sleep apnea an answer for patient who couldn’t stand CPAP

Second-line treatment is one of many options for an epidemic with many causes and serious health effects.
December 27th, 2019

Jim Nixon, 79, has a sharp mind, a quick sense of humor, and a speedy meter as he converses in an accent shaped in Lubbock, Texas. All these things relate to the coordinated actions of two electrodes, though only indirectly.

couple smiles at camera after the husband got a device for sleep apnea, making them both happier.
Dee McClure and Jim Nixon. Nixon’s device for sleep apnea has them both sleeping better. Photo by Todd Neff for UCHealth.

The electrodes are part of an implanted medical device called Inspire, and it only works when he sleeps. Without it, he wasn’t sleeping much. Nixon still managed to run his chain of four Nu-Way dry cleaning shops in his longtime home of Greeley, but he found himself fighting to stay awake in the afternoon and falling asleep at stoplights when he drove from branch to branch. It didn’t take long for Dee McClure to diagnose him with obstructive sleep apnea – an airflow blockage that wakes the body up many times a night.

McClure is a mental health therapist, and while Nixon jokes that “she counsels me,” she has no formal training in sleep-related diagnoses. But she is Nixon’s wife, and she was living through house-shaking snoring and observed as Nixon stopped breathing for 20 or 30 seconds or longer as he slept, over and over – not to mention the night terrors that would rip them both into wide-eyed consciousness two or three times a week.

In 2012, Nixon went to see Dr. Kelli Janata, a pulmonologist and sleep-medicine specialist who now directs the UCHealth Longs Peak Hospital Sleep Lab. He was referred to her not because of sleep apnea, but rather what would be diagnosed as moderate COPD. Nixon mentioned the possibility of sleep apnea; Janata had him do an overnight sleep study.

Extreme sleep apnea

The study ended long before daybreak. As Nixon described it, “The numbers were so high I was going to break the machine.” Even if the diagnostic equipment in the sleep lab was holding up just fine, his case was extreme. Stop breathing from five to 15 times an hour and it’s called mild sleep apnea; 16 to 30 times an hour is classified as moderate; more than 30 times an hour, severe. Nixon had stopped breathing an average of 113.8 times an hour by the time they finally woke him up at 1 a.m. and said he may as well go home. Nixon now officially counted among the 15 million to 22 million Americans with confirmed sleep apnea (he had been, until that night, among the 24 million others suspected to have undiagnosed sleep apnea).

diagram of sleep apnea’s complex anatomy.
Sleep apnea’s complex anatomy. Getty Images.

The list of sleep apnea’s health and quality-of-life impacts is long and seems to be growing: headaches, memory loss, attention deficits, moodiness, depression, impotence, fatigue, immune-system weakness, heart problems, heightened Alzheimer’s risk, the list goes on. Janata’s collection of alarming facts includes a nearly doubled risk of crashing one’s car because of fatigue sleep apnea leaves behind.

A recent National Geographic feature on sleep science touched upon the restorative and mind-sharpening powers, the magic of the dream state, and all the other mysterious benefits sleep imparts. It then concluded, “Maybe, then, we’ve been asking the wrong question about sleep, ever since Aristotle. The real wonder isn’t why we sleep. It’s why, with such an incredible alternative available, do we bother to stay awake?”

Janata prescribed a CPAP (continuous positive airway pressure) machine, which was and remains the first-line treatment for moderate to severe sleep apnea – and one that’s 100% effective if the patient can wear it comfortably. That’s been a big “if,” though: Depending on the study, somewhere between 30% and 60% of patients have had comfort issues with CPAP machines.

For the better part of five years, Nixon gave the CPAP machine his best effort – he really did. But the mask didn’t fit quite right and it leaked and the machine dried out his throat. He had a hard time sleeping with it on, and the machine itself made a whooshing sound with each of Nixon’s breaths. That, in addition to the snoring that continued, kept McClure awake, too.

Roll the DISE

In 2017, Janata mentioned the Inspire implantable device for sleep apnea as a possibility for Nixon. It had been approved by the U.S. Food and Drug Administration as a second-line therapy for those who couldn’t tolerate or weren’t helped by CPAP machines. She referred him Dr. Katherine Green, an ear, nose and throat surgeon and sleep medicine expert at UCHealth University of Colorado Hospital on the Anschutz Medical Campus.

Green met with Nixon at the UCHealth Sleep Medicine Clinic – Anschutz Medical Campus, where Green is medical director. The clinic, unique to the region, combines pulmonary sleep specialists, airway specialists, physician’s assistants, psychiatrists, and neurologists to diagnose and treat all variety of sleep disorders – insomnia, narcolepsy, parasomnia, restless leg syndrome, and, yes, sleep apnea.

Green emphasizes that sleep apnea can present with many different symptoms. The first step with all patients is to determine the severity of sleep apnea. Diagnosis can involve a home sleep study and, in more complex cases, an in-lab sleep study at the UCHealth Sleep Lab – Stapleton which, as with studies done at the sleep lab at UCHealth Longs Peak Hospital, involves brain-activity-monitoring electroencephalograms; eye-movement detection; and the monitoring of heart rate, airflow, leg movement, and chin-area muscle.

man holds romote to a device for sleep apnea up to his chest, where the device has been implanted.
Jim Nixon holds his Inspire controller over the implant as he does each night before going to sleep. Inspire is a device for sleep apnea and has Jim sleeping again at night. Photo by Todd Neff for UCHealth.

A sleep study will diagnose the severity of sleep apnea but can’t shed light on precisely what’s causing a given patient’s airway blockage. A bottleneck in the nose can render an otherwise appropriate CPAP solution intolerable. The palate can be the problem, or the tongue, or the epiglottis, or some combination of them. So before settling on a surgical option, Green performs a drug-induced sleep endoscopy, or DISE, which shows exactly where the problem is.

Diagnostic precision is particularly important for patients facing surgery. There are now about a dozen sleep apnea procedures, Green says, and the nature of the blockage can dictate which may be appropriate.

 “There is no perfect procedure,” she said. “An airway evaluation with DISE can provide a more educated selection of the most successful surgery.”

Inspire device for sleep apnea

That said, like Janata, Green is a strong proponent of CPAP machines, which work for most patients and which have improved drastically in recent years. They’re smaller, the nose and/or mouthpieces fit better, the air pressures are finely adjustable, the humidifiers work better, and they’re all but silent as they operate. But when CPAP fails for reasons of comfort or claustrophobia, there are other options. They range from custom-made oral appliances that pull the jaw forward to complex surgeries to the tongue and throat that can involve long, painful recoveries. For Nixon, Green suggested the Inspire device for sleep apnea.

It’s implanted like a pacemaker, but on the right side of the chest. It has two wires. One is implanted between the muscles of the rib cage and detects breathing patterns. The other is placed around the nerve that controls the movement of the tongue. Stimulation causes the nerve to push the tongue forward and opens the airway.

Green implanted the device for Nixon during an outpatient procedure in late November 2017. About a month later, Green activated the device for sleep apnea in clinic and Nixon began using therapy at home nightly. She adjusted the simulation level over the next couple of months until they found settings that effectively eliminated his apneic events at home.

A remote control that looks like a sleek wireless mouse turns the Inspire device on and off. Nixon turns it on with the push of a button as he holds the remote against his chest. He has it set to start working 30 minutes afterwards, giving him time to drift into sleep first. The Inspire device doesn’t deliver constant simulation. Rather, the tongue nerves get an electrical nudge when the electrode sensing his breathing pattern, and stimulates every time he takes a breath.

The Inspire device has worked very well, Nixon says. The night terrors have all but disappeared – two or three in the two years he has had the device for sleep apnea. He feels much, much better-rested, he says, and no longer finds red lights to be a sleep trigger.

McClure says she’s sleeping much better, too – which is only fair, given that it was she who started her husband down the road to pleasant dreams via minimally invasive surgery in the first place. Sometimes, the right medical device for sleep apnea can help more than just the patient who gets it.

 

About the author

Since 2008, Todd Neff has written hundreds of stories for University of Colorado Hospital and UCHealth. He covered science and the environment for the Daily Camera in Boulder, Colorado, and has taught narrative nonfiction at the University of Colorado. He was a 2007-2008 Ted Scripps Fellowship recipient in Environmental Journalism at CU.

His latest book, "The Laser That’s Changing the World," tells the story of the inventors and innovators who saw, and ultimately realized, the potential of lidar to help solve problems ranging from smokestack-pollution detection, ice-sheet mapping, disaster recovery, and, ultimately, autonomous-vehicle guidance, among many other uses. His first book, "From Jars to the Stars," recounts how Ball Aerospace evolved from an Indiana jar company - and a group of students in a University of Colorado basement - to an organization that managed to blast a sizable crater in the comet 9P/Tempel 1. "Jars" won the Colorado Book Award for History in 2012.

Todd graduated with a business degree from the University of Michigan, where he played soccer, and with a master’s degree from the Fletcher School of Law and Diplomacy at Tufts University. Before becoming a journalist at the turn of the millennium, he was an IT and strategy consultant. He once spoke fluent Japanese and still speaks fluent German.

When not writing, he spends time with teenage daughters and wife Carol, plays soccer, and allows himself to be bullied by a puggle he outweighs by a factor of seven.