we’re not. —M. Boyd Gillespie, MD, MSc
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February 2023Long-Term Impact on Patient Health
Researchers are currently studying the impact of HNS on common complications of OSA. According to the International Consensus Statement on Obstructive Sleep Apnea published in September 2022, HNS reduced insulin resistance and improved glucose tolerance in non-diabetic patients, and at least one study found that HNS improved systolic and mean arterial blood pressures of baseline hypertensive patients (Int Forum Allergy Rhinol [published online ahead of print September 6, 2022]. doi:10.1002/alr.23079).
Because HNS treatment of OSA was first approved in 2014, questions remain about its long-term impact on patient health. “We know it reduces snoring, improves sleep quality, and reduces daytime sleepiness. We don’t know yet if it truly reduces risk of heart attack and stroke,” Dr. Gillespie said. “I think that’s where we need to go next in our research. The device costs, all in, about $40,000. That’s certainly worthwhile if we’re reducing risk of stroke and heart disease. It may not be as worthwhile if we’re not.”
Jennifer Fink is a freelance medical writer based in Wisconsin.
New Hypoglossal Nerve Stimulation Devices
At least two new hypoglossal nerve stimulation (HNS) devices are being evaluated in clinical trials, and more are in development.
LivaNova THN Sleep Therapy
London-based LivaNova received a CE mark for its aura6000 HNS device in 2012. In 2021, the company received an investigational device exemption from the FDA to proceed with the “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation (OSPREY)” study. The first U.S. patient was implanted in early 2022, and the study continues at approximately 20 sites in the United States, with plans to enroll a maximum of 150 adult patients with moderate to severe obstructive sleep apnea (OSA) who do not achieve results from a traditional CPAP machine or have declined its use.
Nyxoah Genio
Billed as “the world’s first leadless and battery-free” HNS treatment for OSA, the Genio device from Belgium-based Nyxoah utilizes bilateral nerve stimulation instead of unilateral stimulation and is implanted via one incision, not two. The device received its European CE mark in 2019 and in July 2022 received Breakthrough Device Designation from the FDA for the treatment of complete concentric collapse (CCC) patients (who are not eligible for HNS treatment with Inspire, the only FDA-approved device). A clinical trial (ClinicalTrials.gov Identifier: NCT03763682), underway now, will assess the use of the Genio system to treat moderate to severe OSA and CCC of the soft palate in adult patients.