Implantable device makes gains on CPAP therapy

CLEVELAND - A new device that stimulates a nerve at the back of the tongue to open a person's airway effectively treats obstructive sleep apnea (OSA), making it a viable alternative to CPAP therapy, researchers say in a study published in the Jan. 9 issue of the New England Journal of Medicine.

The implantable device is called Inspire Upper Airway Stimulation. It delivers a mild electrical stimulation to the base of the tongue, preventing it from collapsing and blocking the airway. Patients turn the device on and off with a hand-held programmer.

“This device is a first of its kind therapy, and has the potential to help the many people suffering form moderate to severe sleep apnea who are unable to use or cannot tolerate CPAP,” said Kingman Strohl, senior study author, pulmonologist at University Hospital Case Medical Center and professor of Medicine at Case Western Reserve University School of Medicine. 

Researchers studied 126 patients with moderate to severe sleep apnea who could not use or adhere to CPAP therapy. To qualify for inclusion, study subjects could not be obese and had to show their OSA was tongue-related. Earlier studies showed the implant is less effective in obese patients and those with soft-palate collapse, according to news reports.

To conduct the study, researchers measured the patients' apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) and found that after a year using the device patients' median AHI score fell 68% and their median ODI score dropped 70%, according to the release.

A sub-study then found a sharp rise in the AHI index, fatigue and snoring of 23 patients who had the device removed for a week, researchers said.

The FDA is reviewing data on the Inspire Upper Airway Stimulation device, which has been provisionally approved for use in Europe, according to the release.

Device maker Inspire Medical Systems funded the study.