Obstructive sleep apnea remains one of the most prevalent yet undertreated chronic conditions in otolaryngology, affecting millions of adults worldwide. While positive airway pressure is the established first-line therapy, long-term intolerance and suboptimal adherence substantially limit its real-world clinical benefit for a large share of patients. Existing distal hypoglossal nerve stimulation systems have filled an important gap for selected patients, but they rely on strict preoperative selection —including drug-induced sleep endoscopy to rule out complete concentric pharyngeal collapse—and often impose body mass index limits, leaving many patients without access to implantable neurostimulation therapy.
Unlike distal stimulation that selectively activates the genioglossus to pull the tongue forward, proximal hypoglossal nerve stimulation targets the main nerve trunk with a multi-contact electrode array, activating both tongue protrusor and retractor muscles at once. This broader activation not only provides anterior mechanical support but also increases overall tongue stiffness and stabilizes the hyoid complex and lateral pharyngeal walls, delivering more global upper airway stabilization across different collapse patterns.
The pivotal OSPREY trial, published in Annals of Internal Medicine in April 2026, enrolled adults with moderate-to-severe obstructive sleep apnea who could not tolerate positive airway pressure across 23 U.S. centers. With a mean baseline apnea-hypopnea index of approximately 36 events per hour and a body mass index cutoff of 35 kg/m 2 , the trial included a broader, more representative patient population than many earlier distal stimulation studies, and notably did not use drug-induced sleep endoscopy for screening or exclude patients with complete concentric collapse. Participants were randomized 2:1 to active treatment starting one month after implantation or a delayed-activation control group, with controls crossing over to active therapy after month 7. At the 7-month primary endpoint, more than half of actively treated patients achieved a clinically meaningful apnea–hypopnea index (AHI) response alongside significant improvements in oxygen desaturation, nocturnal hypoxemia, respiratory arousal frequency, daytime sleepiness and sleep-related quality of life. Control patients saw similar gains after crossing over to active stimulation by month 13, confirming the effect was driven by active neurostimulation rather than procedural placebo. With an outpatient implantation procedure and a favorable safety profile over 13 months of follow-up, the system has now received U.S. regulatory approval. The author notes that these findings significantly expand eligible patient populations for airway neuromodulation, and future multi-site stimulation strategies may further extend benefits to patients with diverse airway collapse patterns.
The work titled “ A New Randomized Trial Broadens Neurostimulation Options for Obstructive Sleep Apnea: Insights from the OSPREY Trial ”, was published on ENT Discovery (published on Jun 10 , 2026) .
ENT Discovery
Experimental study
Not applicable
A New Randomized Trial Broadens Neurostimulation Options for Obstructive Sleep Apnea: Insights from the OSPREY Trial
10-Jun-2026