Insomnia May Reduce Upper Airway Stimulation Adherence

SAN ANTONIO -- Since its FDA approval in 2014, upper airway stimulation (UAS) has proven to be an effective alternative to continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA) in patients who are CPAP intolerant.

But research presented here suggested that, like CPAP, adherence with UAS may be poorer in patients with comorbid insomnia.

Eleven of the 20 veterans with OSA who received the treatment in the pilot study had insomnia, and these patients appeared to be less adherent and showed less improvement after a month than patients without insomnia.

The difference was not statistically significant, but Douglas M. Wallace, MD, of the University of Miami Miller School of Medicine, said larger and longer studies are warranted to better understand the impact of comorbid insomnia on UAS.

Wallace presented the findings at SLEEP 2019, the annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society.

"Around half of veterans who have OSA also have insomnia, so this is not an insignificant issue given that the Veterans Administration now covers this procedure for those who qualify," he told MedPage Today.

He said the typical cost of the treatment is around $30,000 and the surgery required to implant the pacemaker-sized neurostimulator device and leads, marketed by Inspire Medical Systems, takes about 3 hours.

The neurostimulator is implanted beneath the clavicle and a lead that senses breathing is placed between the external and intercostal muscles. A second stimulation lead is attached to the branch of the hypoglossal nerve that produces tongue protrusion.

The system, which is turned on by the patient before sleep, is designed to sense breathing patterns and deliver mild stimulation to maintain airway patency by moving the tongue slightly forward.

"The patient has a remote control, which they turn on when they go to bed at night, which makes the tongue protrude in synch with respiration to prevent obstruction," Wallace said.

The device was approved by the FDA for patients with moderate to severe OSA who are unable to use CPAP, who do not have concentric collapse of the airway at the soft palate, and are not obese -- body-mass index (BMI) up to 32.

While adherence is less of an issue with UAS than with CPAP, it is still an issue, Wallace said. "With the stimulation you can feel the tongue move, and that bothers some people. So they may not turn the device on when they go to sleep."

He added that people with insomnia are often hypersensitive to stimulation, which may explain why they may be less adherent to UAS and CPAP.

In the pilot study the veterans without insomnia had the devices turned on close to 6 hours more per week than those with insomnia.

A second study which examined the uptake of UAS at a large academic sleep surgery center among patients with OSA who were candidates for the procedure, found that just 17% of patients offered the surgery elected to have it.

The poster study by Sasikarn Poomkonsarn, MD, of Stanford University School of Medicine, and colleagues included 131 patients presenting to the Stanford Sleep Surgery clinic who were offered UAS from October of 2016 through 2018.

A total of 22 of the patients underwent UAS (male-to-female ratio of 20:2). and the mean age of patients who elected to have the surgery was 66.7±8 years. The mean BMI was 26.9±4.

Five patients had cardiovascular disease, nine had hypertension, three had pulmonary disease, and two had diabetes mellitus; one patient had a history of stroke.

A total of 18% of participants had relapsed from a previous OSA surgery, including two each from soft tissue surgery and maxillomandibular advancement. More than a third (36%) of patients required additional surgery to reverse complete concentric collapse of the velum before UAS.

The researchers noted that the fact that the average age of patients opting for surgery was over 65 "may reflect both the current insurance climate (easier to approve under Medicare), and the use of UAS after [CPAP] trial and relapse from previous history."