⚠️ Small Study / Early Comparative Evidence
The OSPREY RCT randomized 104 adults with moderate-to-severe OSA at 23 US sites to proximal hypoglossal nerve stimulation (pHGNS) versus delayed-activation control over 7 months. No serious procedure-related adverse events were reported.
Clinical Considerations
- 58.2% of treated patients met the composite primary endpoint (>50% AHI reduction and AHI <20) versus 13.5% of controls at month 7.
- ODI reduction ≥25% occurred in 68.7% of treated patients versus 37.8% of controls, with parallel Epworth Sleepiness Scale improvement only in the treatment arm.
- pHGNS targets proximal nerve portions with multicontact stimulation and easier electrode implantation than distal HGNS, but no head-to-head trial against distal HGNS exists.
- Limitations are significant: unblinded design, n=104, 7-month follow-up, and patient-reported outcomes vulnerable to expectancy effects.
Practice Applications
- Consider pHGNS as an emerging option for moderate-to-severe OSA in PAP-intolerant adults.
- Recognize the absence of head-to-head comparison with established distal HGNS systems.
- Interpret Epworth improvements cautiously given the unblinded design.
- Monitor longer-term durability and safety data as the open-label extension matures.
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