Objective/Hypothesis: The ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA.Study Design: Cohort Study.Methods: Demographic and sleep study data collection occurred at baseline, implantation visit, post-titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ≥50% decrease in Apnea-Hypopnea Index (AHI) and AHI ≤20 at the 12-month visit.Results: The registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6-month follow-up and 382 have completed the 12-month follow-up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6-45.0) to 9.5 (IQR, 4.0-18.5); mean, 35.8 AE 15.4 to 14.2 AE 15.0, P < .0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7-16) to 7.0 (IQR, 4-11); mean, 11.4 AE 5.6 to 7.2 AE 4.8, P < .0001. Therapy usage was 5.6 AE 2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response.Conclusions: Across a multi-institutional study, UAS therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable and adherence is high.

Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnoea. The aim of this study was to identify predictors of UAS therapy response in an international multicentre registry.Patients who underwent UAS implantation in the United States and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnoea/hypopnoea index (AHI), Epworth sleepiness scale (ESS), objective adherence, adverse events and patient satisfaction measures. Post hoc univariate and multiple logistic regression were performed to evaluate factors associated with treatment success.Between October 2016 and January 2018, 508 participants were enrolled from 14 centres. Median AHI was reduced from 34 to 7 events·h−1, median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. In post hoc analyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1-unit increase in body mass index (BMI), there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as statistically significant predictor of treatment success.In a large multicentre international registry, UAS is an effective treatment option with high patient satisfaction and low adverse events. Increasing age and reduced BMI are predictors of treatment response.

This study provides the first evidence of a strong influence of geolocation and ethnicity on the phenotype of primary SjS at diagnosis.

4. Laryngoscope, 128:509-515, 2018.

Selective upper airway stimulation (UAS) is a novel therapy for patients with obstructive sleep apnea (OSA). The aim of this study was to analyze the application and outcome of UAS in patients with moderate to severe OSA in the clinical routine of a tertiary referral center. The design of this study is single-center, prospective clinical trial. Thirty-one patients who received a UAS device (Inspire Medical Systems) were included. Treatment outcome was evaluated at 2, 3, 6, and 12 months after surgery. Data collection included demographics, body mass index (BMI), apnea hypopnea index (AHI), oxygen saturation and desaturation index (ODI), Epworth Sleepiness Score (ESS), adverse events, and adherence to therapy. Sher criteria were used to evaluate treatment response. The mean age was 59.6 years with thirty patients being male. Mean BMI was 28.8 kg/m. The mean pre-implantation AHI of 32.9/h could be reduced to 7.1/h after 12 months (p < 0.001). The mean pre-implantation ODI of 30.7/h could be reduced to 9.9/h after 12 months (p = 0.004). The mean pre-implantation ESS of 12.6 could be reduced to 5.9 after 12 months (p = 0.006). Serious adverse events did not occur. Therapy adherence was a usage of 6.6 h/night after 12 months. OSA severity and subjective daytime sleepiness were improved in patients with moderate to severe OSA after receiving UAS therapy. Patients maintained high adherence to therapy use after 12 months. It is encouraging that UAS has been shown to be successfully implemented in the routine clinical management of OSA outside of a clinical trial setting.