0643 Next-Generation Hypoglossal Nerve Stimulation Therapy for the Treatment of Obstructive Sleep Apnea: Final Study Results

Abstract Introduction Unilateral hypoglossal nerve stimulation with respiratory sensing (URS-HGNS) is a proven therapy for moderate-to-severe Obstructive Sleep Apnea (OSA) patients who struggle with PAP. The next-generation URS-HGNS System (Inspire V) is designed to simplify the procedure by including sensing technology within the implanted pulse generator (IPG). It is also designed to provide enhanced patient comfort and more efficient patient management. This study includes results of the first implants of this next-generation technology. Methods This prospective, multicenter study of 44 patients at 2 centers in Singapore, with the URS-HGNS system, followed participants for 6 months post-activation. Baseline and medical history were collected, including in-lab polysomnography. Implant duration was reported and compared to the previous generation. Participants underwent in-lab polysomnography at 6 months (performed at a single device setting). Epworth Sleepiness Scale (ESS) and Function Outcomes of Sleep Questionnaire (FOSQ) were collected at baseline and 6 months. Patient satisfaction was reported at 6 months. Results A total of 44 participants (88.6% male; mean age: 55.7±10.2 yrs; baseline BMI: 26.9±2.8 kg/m2) were enrolled and successfully implanted. No device revisions or explants were reported. Implant times decreased by 20.4% compared to the previous URS-HGNS system. Respiratory sensing was superior to the previous generation of technology (Inspiratory Phase Overlap Percent: 87.1% vs 79.4%, p=< 0.001). One patient exited prior to 6-month visit (declined further study visits but remains in follow-up). A significant reduction in OSA severity was reported at 6 months (mean AHI decrease: 25.5±14.6 events/hr, p< 0.001; from median AHI of 34.4 at baseline to 8.4 at 6 months). Supine AHI decreased 68.1%, from median of 36.5 at baseline to 12.3 at 6 months. The Sher20 responder rate was 79.5% (assumes early exit was a non-responder). Mean adherence at 6 months was 5.9±1.2 hrs/night. Daytime sleepiness normalized at 6 months (median 7, p-value< 0.001) with a decrease in ESS from 11 to 7. FOSQ showed improvement from 15.0 to 17.9, p-value< 0.001. Patient satisfaction was 91%. Conclusion This next generation URS-HGNS technology facilitates more efficient implants, significant improvements in OSA severity and symptoms, and excellent therapy adherence. Support (if any) The Next Generation Study is sponsored by Inspire Medical Systems, Inc.