NOTE: I was a paid Nyxoah consultant, reviewing preoperative drug-induced sleep endoscopy videos for their clinical trials. I was a coauthor on the p

I have written previously about the Genio system from Nyxoah and aura6000 system from Livanova, including an update on their clinical trials after the 2024 International Surgical Sleep Society meeting. Over the past year, results from Nyxoah’s DREAM (Dual-sided hypoglossal neRvE stimulAtion for the treatMent of obstructive sleep apnea) trial have been accepted for publication in the Journal of Clinical Sleep Medicine. The sleep community has been awaiting trial results for numerous hypoglossal nerve stimulation technologies, so these results have been eagerly anticipated.

What are the DREAM Study Results?

Of 115 study participants undergoing surgery, only 110 had any data (only 88 with sleep study data) at 12 months to calculate outcomes. The substantial loss to follow up was related to a variety of factors, including potential ineffectiveness of the treatment. As such, the study results are reported conservatively, assuming that EVERY study participant without complete data was a nonresponder to treatment. Even with this conservative approach, the responder rate was 63%/71% (two primary outcomes). However, when looking only at those individuals with full data available at 12 months, the results are substantially better (82%/92% response rates). The real response rate is likely somewhere in the middle, as a good portion of those who withdrew from the study before 12 months were not benefiting from the treatment. For those with study results at 12 months, the median reduction in the AHI was 70%, reflecting a substantial improvement in sleep apnea for the middle-of-the-road response.

One of the intriguing things is that, in those with available sleep study date at 12 months, there was substantial improvement in the apnea-hypopnea index (AHI) even when study participants were sleeping in the supine position. Specifically, the supine AHI decreased from 49 to 23 events/hour. While my patients with Inspire’s Upper Airway Stimulation technology who do well also seem to have improvement in supine AHI, there are some studies suggesting that this may not be as consistent and that Inspire may have decreased response rates in those with high supine AHI.

From a safety perspective, there were 10 serious adverse events (9%, 10/115), with 8 of those related to the device or procedure. There were other adverse events as well. In short, the safety profile was similar to that of the Inspire hypoglossal nerve stimulation system and what one would expect for a surgery and treatment like this.

FDA Approval: August 2025

Are these trial results encouraging? Well, the United States Food and Drug Administration reviewed the data and approved the device for the treatment of moderate to severe obstructive sleep apnea on August 8, 2025. This is an important evolution in the treatment of obstructive sleep apnea, as it offers patients in the United States a second option if they meet the criteria that are similar to those for Inspire therapy, including moderate to severe obstructive sleep apnea (AHI 15-65 events/hour) and an inability to tolerate or achieve sufficient benefit with positive airway pressure therapy (for example, CPAP). There are other eligibility criteria as well, as the DREAM Study also included drug-induced sleep endoscopy and excluded those with complete concentric collapse related to the soft palate (similar to Inspire’s STAR Trial).

Is Nyxoah’s Genio Better than Inspire’s Upper Airway Stimulation?

Each of these systems has strengths and limitations. Ultimately, the decision about what is best for a certain patient will be based on a combination of the patient’s attributes (including DISE), the evidence from research studies (although we do not have direct comparisons now), and patient preferences. I strongly believe that there is room for more than one product in this space, so I expect that both of these technologies will soon be available for the treatment of patients with obstructive sleep apnea.

What’s Next?

Well, the device is not yet widely available for clinical use, but I hope and plan on being among the first group of surgeons offering this to patients outside of the clinical trial. There is an ongoing patent lawsuit filed by Inspire against Nyxoah, and it is unclear how this may or may not delay or prevent the introduction of Nyxoah’s Genio technology to patients in the United States.

We shall see what the future holds…