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Proximal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea in the OSPREY Study : A Randomized Controlled
Atul Malhotra1, Alan R Schwartz2, Eric Lovett3
1Pulmonary, Critical Care, Sleep Medicine and Physiology, Department of Medicine, University of California San Diego, La Jolla, California (A.M.).
Annals of Internal Medicine
|April 20, 2026
Summary
Proximal hypoglossal nerve stimulation (pHGNS) effectively treats moderate-to-severe obstructive sleep apnea (OSA) in patients intolerant to positive airway pressure therapy. This study showed significant improvements in apnea-hypopnea index and patient-reported outcomes with pHGNS compared to control.
Area of Science:
- Medical Devices
- Sleep Medicine
- Neuromodulation
Background:
- Obstructive sleep apnea (OSA) affects millions, with limited treatment options for those unable to tolerate positive airway pressure (PAP) therapy.
- Hypoglossal nerve stimulation (HGNS) offers an alternative, with proximal HGNS (pHGNS) presenting potential advantages in electrode placement and stimulation.
- This study investigates the efficacy and safety of pHGNS in moderate-to-severe OSA patients.
Purpose of the Study:
- To evaluate the effectiveness of proximal hypoglossal nerve stimulation (pHGNS) in treating moderate-to-severe obstructive sleep apnea (OSA).
- To assess the safety profile of pHGNS in this patient population.
- To compare pHGNS outcomes against a control group in patients with OSA.
Main Methods:
- A 7-month randomized controlled trial followed by a 6-month open-label extension involving 104 adult patients with moderate-to-severe OSA across 23 U.S. health centers.
- Patients received pHGNS implantation and were randomized 2:1 to receive therapy starting at month 1 or month 7 (control).
- Primary endpoint: proportion of patients achieving >50% AHI reduction and AHI < 20 events/h at 7 months. Secondary endpoints included oxygen desaturation index (ODI) and Epworth Sleepiness Scale (ESS) improvements.
Main Results:
- At 7 months, 58.2% of the pHGNS treatment group achieved the primary endpoint versus 13.5% in the control group.
- The treatment group showed significant improvements in ODI (68.7% vs. 37.8%) and median ESS scores (10.0 to 6.0) compared to the control group.
- No serious procedure-related adverse events were reported, indicating a favorable safety profile for pHGNS.
Conclusions:
- Proximal hypoglossal nerve stimulation (pHGNS) demonstrated clinically significant efficacy in improving OSA parameters and patient-reported outcomes compared to control.
- pHGNS represents a viable therapeutic option for patients with moderate-to-severe OSA, particularly those who cannot tolerate positive airway pressure therapy.
- Further research with larger sample sizes and longer follow-up is warranted to fully elucidate the long-term benefits and safety of pHGNS.
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