0627 Outcomes in Patients with Comorbid OSA and RLS Following Treatment with URS-HGNS Therapy: Results from the ADHERE Registry

Abstract Introduction Restless leg syndrome (RLS) is a common chronic neurological disorder, which can cause sleep disturbances, similar to those seen in patients with obstructive sleep apnea (OSA). Literature suggests that the prevalence of comorbid OSA and RLS (ComOSAR) is 16-24%. Unilateral hypoglossal nerve stimulation with respiratory sensing (URS-HGNS) is a proven therapy for moderate-to-severe OSA patients who struggle with positive airway pressure (PAP). Given the issues with insomnia related to ComOSAR, determining whether treatment of OSA using URS-HGNS is effective in these patients is of interest. Methods The ADHERE Registry is a real-world registry of 5,000 enrolled participants who were implanted with URS-HGNS throughout the US and Europe. Patients were followed up to 2 years post-implant. RLS was captured as a comorbidity in the ADHERE Registry starting in March 2020. Therefore, patients were included in this analysis (n=1689) if they were enrolled after March 2020 and had a final follow-up visit with at least one of the following reported: AHI, ESS or therapy use. Follow-up information for this analysis includes an all-night sleep study (with no device setting changes), daytime sleepiness (ESS) and therapy adherence. Patients with RLS were matched to those without RLS based on: age, gender, baseline AHI, prior OSA treatment. Results Per the matched patient analysis, a total of 53 patients with RLS were matched to those without RLS. There were no significant differences in demographics or baseline AHI and ESS. Patients in the RLS group were found to have significantly lower final median AHI (10.5 vs.15.8, p=0.043) compared to non-RLS patients. ESS improved with URS-HGNS treatment in both groups. Final median ESS in the RLS group was not significantly different than the non-RLS group (8.0 vs 6.0, p=0.41). Similarly, mean therapy use was similar between the two groups (6.0±2.1 vs 6.3±2.1 hours/night, p=0.42). Conclusion This matched patient analysis of ADHERE Registry patients demonstrates that patients with ComOSAR are generally well treated with URS-HGNS therapy. The differences in daytime sleepiness and therapy use are neither statistically nor clinically significant. Support (if any) The ADHERE Registry is sponsored by Inspire Medical Systems, Inc.