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SLEEP 2026 | OSPREY study: proximal hypoglossal nerve stimulation for obstructive sleep apnea

Atul Malhotra, MD, University of California San Diego, San Diego, CA, provides an overview of the OSPREY study (NCT04950894) evaluating proximal hypoglossal nerve stimulation for obstructive sleep apnea. He discusses the key efficacy and patient-reported outcomes from this randomized controlled trial, as well as emerging data on PolySync programming, which may improve responses in initial non-responders. This interview took place at the 40th annual meeting of the Associated Professional Sleep Societies (APSS) in Baltimore, MD.

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Transcript

So the OSPREY study was published in the New England Journal of Medicine, I believe in March of 2026, and that was a multicenter study looking at proximal hypoglossal nerve stimulation in a randomized controlled study. It was a follow-up to the so-called THN3 study that we published with Alan Schwartz as the first author in JAMA ENT two years prior. The literature in that area is interesting. The STAR trial was published in the New England Journal of Medicine in January of 2014...

So the OSPREY study was published in the New England Journal of Medicine, I believe in March of 2026, and that was a multicenter study looking at proximal hypoglossal nerve stimulation in a randomized controlled study. It was a follow-up to the so-called THN3 study that we published with Alan Schwartz as the first author in JAMA ENT two years prior. The literature in that area is interesting. The STAR trial was published in the New England Journal of Medicine in January of 2014. On that basis, the FDA approved the Inspire device in April of 2014, but it was based on a case series. And so having randomized controlled evidence is quite helpful. So in the OSPREY study that we recently published in the New England Journal of Medicine, we are seeing marked improvements with active treatment as compared to the control group, who had an implant put in but the device was not turned on. And by 13 months we’re seeing marked improvements in responders to the treatment. We’re now looking at something called PolySync, which is a way of reprogramming the different electrodes, and we’re seeing very good response rates. In fact, in 10 or 15 minutes, we’re about to present a poster that looks at the results from PolySync, and we’re seeing marked improvements even in the patients who didn’t respond initially in the trial. So we’re getting very high response rates indeed.

The advantage of the OSPREY study is not just that it was a randomized controlled study. You need a control group to interpret a lot of these things. We had good diversity in terms of the participants, we did not require DISE, that is, drug-induced sleep endoscopy, and we studied a range of different patient-reported outcomes, which also improved concomitantly with the improvements in the apnea-hypopnea index that we observed in the OSPREY study. And so that’s really quite exciting. There are other devices being looked at. So the DREAM study was published in the Journal of Clinical Sleep Medicine, looking at the so-called Nyxoah device, which uses a midline incision. That study was a case series, once again, and there were about 23% dropouts from that study, so it becomes harder to interpret. So we’re quite excited about proximal hypoglossal nerve stimulation. It’s quite a quick procedure and it’s relatively easy to perform, my surgical colleagues tell me, and so we’re hoping that gets some traction. The recent FDA approval of proximal hypoglossal nerve stimulation was also quite exciting.

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