Abstract Introduction Obstructive sleep apnea (OSA) is commonly associated with impaired sleep quality, daytime function, and cardiometabolic risk. Unilateral hypoglossal nerve stimulation with respiratory sensing (URS-HGNS, Inspire Medical Systems, Inc.) is a proven therapy with established safety and efficacy through the STAR pivotal trial. A global registry was established to collect information on the outcomes of URS-HGNS in a real-world setting. Methods The registry was designed to enroll 5,000 participants who were implanted with URS-HGNS throughout the US and Europe. Baseline information included demographics, medical history, sleep study results, and daytime sleepiness using the Epworth Sleepiness Scale (ESS). Data was captured at post-titration (6 months post-implant) and a final visit (up to 2 years post-implant). Patient reported outcomes included ESS and patient satisfaction. Follow-up information also included therapy use and the Clinical Global Impression of Improvement (CGI-I). An optional all-night sleep study - without changes to device settings - was performed at the final visit. Results Participants were primarily white (92.4%) males (71.6%) with a mean age of 61.2±11.0 years, mean BMI of 29.2±3.6 kg/m2, baseline median AHI of 32.0 events/hr and median ESS of 11. Prior PAP use was reported in 95.6% of participants. Results of the reported sleep studies demonstrate a significant reduction in OSA severity. Post-titration reported sleep studies (a mix of titration and all-night effectiveness; N=3745) show a median AHI of 9.9 events/hr, p 0.001. Final visit all-night effectiveness sleep studies (attended by 2,344 participants) result in a median AHI of 12.3, p 0.001; with a median decrease in AHI of 62%. Significant improvement in daytime sleepiness was reported, resulting in a median ESS score of 6 at both post-titration and final follow-up (p 0.001). Patient satisfaction was 87.9% at final visit. Mean therapy usage was 6.4±2.2 hours/night at post-titration and 5.8±2.2 hours/night at final visit. CGI-I showed that 90% of physicians saw improvement in their patients. Conclusion This global registry of URS-HGNS demonstrates durability of the therapy in a real-world population with results that are aligned with the initial pivotal trial. Support (if any) The ADHERE Registry is sponsored by Inspire Medical Systems, Inc.
Soose et al. (Fri,) studied this question.