In May, the U.S. Food and Drug Administration (FDA) approved a new surgical treatment option for use in patients with sleep apnea who do not respond well to traditional CPAP therapy.
The Inspire Upper Airway Stimulation device uses three implanted components controlled through a small remote to provide mild stimulation to maintain an open airway. The device’s neurostimulation generator is implanted in the chest, with a lead that stimulates a nerve running from the ear to the jaw.
The main FDA clinical trial evaluated 126 patients over 12 months at 22 medical centers across the United States and Europe. Data from the trial were submitted to the FDA in 2013. Results were published in the Jan. 9 New England Journal of Medicine.
During the initial 12-month follow-up period, patients with the implanted system were found to have a significant reduction in apnea severity, reduced levels of snoring and a significant improvement in daytime functioning.
Eric J. Kezirian, MD, MPH, a professor of otolaryngology–head and neck surgery at the Keck School of Medicine of the University of Southern California in Los Angeles, believes that the device will prove beneficial for certain patients.
“Although the major study included patients with a relatively low body mass index compared to what we see in many sleep apnea patients,” he says, “I believe the difference between the response with other procedures and this device will actually be greater in patients with a somewhat-higher BMI.” He felt that there remains a role for other procedures, including for issues that may not respond to this device such as nasal blockage or large tonsils.
Kezirian also believes that the device will require close collaboration between surgeons and sleep medicine teams to be successful. “The procedure itself is only the first step in the process,” he cautions. “Sleep medicine teams should be able to deal with the nuances of the titration and the adjustments that will be required. The important thing is that for teams that take this on, the study results were pretty solid.”
Inspire’s device has been evaluated in five clinical studies:
- Upper-airway stimulation for obstructive sleep apnea. Strollo PJ Jr, Soose RJ, Maurer JT, et al. N Engl J Med. 2014;370:139-149.
- Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea. Vanderveken OM, Maurer JT, Hohenhorst W, et al. J Clin Sleep Med. 2013;9:433-438.
- Implanted upper airway stimulation device for obstructive sleep apnea. Van de Heyning PH, Badr MS, Baskin JZ, et al. Laryngoscope. 2012;122:1626-1633.
- Therapeutic electrical stimulation of the hypoglossal nerve in obstructive sleep apnea. Schwartz AR, Bennett ML, Smith PL, et al. Arch Otolaryngol Head Neck Surg. 2001;127:1016-1023.