Upper Airway Stimulation Device for OSA Holds Up in Real-World Analysis

INDIANAPOLIS -- Among patients with moderate-to-severe obstructive sleep apnea (OSA) who are intolerant to continuous positive airway pressure (CPAP), an implanted upper airway stimulation device led to similar rates of surgical revision and explantation in postmarketing surveillance data as those reported in the pivotal STAR trial.

Within 1 year of implant, 20,881 devices were effective for the full year, with only 0.7% of devices requiring explant and 1.5% requiring surgical revision, reported Colin Huntley, MD, of Thomas Jefferson University Hospitals in Philadelphia, during a poster presentation at the annual SLEEP meeting, hosted jointly by the American Academy of Sleep Medicine and the Sleep Research Society.

In addition, 5,820 devices had at least 3 years of use, with 3.6% requiring surgical revision between 1 and 3 years and 2.7% requiring explant.

The data also showed a 5-year freedom-from-explant rate of 96% and a 5-year freedom-from-surgical revision rate of 92%.

In the STAR trial published in 2014, which included 126 patients, median apnea-hypopnea index (AHI) scores at 12 months decreased 68% after device activation, from 29.3 events per hour prior to surgical implant to 9.0 events per hour (P<0.001). Three patients (2.5%) required explant between 1 and 3 years.

The Inspire upper airway stimulation device was approved by the FDA in 2014 for use in OSA patients who can not tolerate CPAP, which is the first-line treatment for the disorder.

Michael Coleman, of Inspire Medical Systems, told MedPage Today that more than 50,000 CPAP-intolerant patients have been treated with the upper airway stimulation device outside of clinical trials since its approval, and surgical revision rates and need for explant have been declining steadily in the years since the device was first approved.

The current data analysis included close to 6,000 patients followed for up to 3 years after surgical implant of the upper airway stimulation device from January 2018 through December 2022.

During the same poster session, Lee Shangold, MD, of ENT and Allergy Associates in Port Jefferson Station, New York, presented results from an early feasibility study on the use of noninvasive temporal interference stimulation of the hypoglossal nerve in OSA.

The study, which included 11 recently diagnosed OSA patients, represented the first-in-human trial of the noninvasive strategy, Shangold told MedPage Today.

Five of the 11 patients, including all four women in the study, responded to the nerve stimulation therapy, with AHI reductions of 50% or greater from baseline and an AHI of <20 per hour.

Patient questionnaires indicated that the treatment was well tolerated, Shangold noted.

"The Inspire device has been a game-changer in my practice for my OSA patients who cannot tolerate CPAP," he said. "But a lot of patients do not want to have surgery. This is basically Inspire without surgery. Patients simply put patches on at night before they go to sleep to treat their sleep apnea."

The goal of the noninvasive alternative for hypoglossal nerve stimulation is not to replace CPAP or surgical upper airway stimulation, but to give patients more treatment options, he added.

"Ninety percent of people in this country with sleep apnea are undiagnosed and of those who are diagnosed, about 50% are intolerant of CPAP therapy," Shangold explained. "The population of untreated patients with obstructive sleep apnea is huge, and there is a need for more therapeutic options."