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Introduction The THN3 randomized, controlled trial of moderate to severe obstructive sleep apnea (OSA) showed that proximal (“targeted”) hypoglossal nerve stimulation (HGNS) safely improved sleep-disordered breathing (SDB) and quality of life (QOL) through 11 months of treatment. Outcomes of subjects receiving active proximal HGNS also surpassed those with inactive therapy 4 months post-implant. Herein 3-year outcomes of THN3 are reported and compared to distal HGNS (STAR trial). Methods THN3 OSA subjects (Apnea-Hypopnea Index, AHI, 20-65/hr; BMI ≤ 35 kg/m2, no drug-induced sleep endoscopy screening) were followed long-term. Complete data through 3-year follow-up were analyzed. Efficacy measures comprised AHI, Oxygen Desaturation Index (ODI), %sleep time O2 saturation < 90% (T90), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ) EQ-5D Visual Analog Scale (VAS) and Snore Outcomes Survey (SOS). 36-Month medians were compared against those after 11 months of therapy (Month 12/15) and with STAR. Adverse events (AEs) during Months 12-36 for THN3 and STAR were also compared. Results 75% of THN3 participants (104/138) attended 3-year follow-up, with complete efficacy records in N≥93 except for SOS (N=67, not administered at all sites). Proximal HGNS produced clinically and statistically significant improvements in SDB and QOL at Month 12/15 that were closely maintained at 36 Months (median paired changes at Month 36 from Baseline/Month 12/15: □AHI:-18.2/-0.1, □ODI:-16.2/0.8, □T90:-1.8/0.2, □FOSQ:3.0/0.0, □ESS:-5.0/0.0, □VAS:5.0/0.0, □SOS:37.5/3.1) and were comparable to STAR at 36 Months (□AHI:-19.4, □ODI:-17.2, □T90:-1.5, □FOSQ: 2.6, □ESS:-4.0). Procedure- and device-related AEs respectively totaled (3 and 27)/(4 and 122) in THN3/STAR over Months 12-36. During this time, 3 severe related-AEs occurred in THN3; the most frequent related AEs involved tongue discomfort (N=8, device-related). Conclusion Improvements in sleep apnea and QOL on proximal HGNS at Month 12/15 persisted through at least Month 36. Proximal HGNS long-term efficacy was comparable to distal HGNS. AEs occurred uncommonly during long-term follow-up and were typically mild. Proximal HGNS is a safe, effective, stable, long-term therapy, yielding comparable improvements to distal HGNS in treating moderate to severe OSA. Results of the ongoing, confirmatory OSPREY randomized controlled trial will provide additional insights into therapeutic benefits of proximal HGNS. Support (if any) LivaNova

Introduction THN3 was the first reported parallel-arm, randomized controlled trial (RCT) of hypoglossal nerve stimulation (HGNS), wherein targeted HGNS (THN) was shown to be safe and efficacious at ameliorating sleep disordered breathing in patients with moderate to severe OSA and BMI≤35kg/m2 without screening with drug-induced sleep endoscopy. Unique among reported HGNS trials, separate cohorts of patients receiving early and late THN were followed longitudinally. Methods Measurements of apnea-hypopnea index (AHI) were available Pre-enrollment, Baseline (2 nights), Month 4 and Month 12/15. Except for Pre-enrollment, AHI values were calculated by an independent core laboratory from polysomnographic recordings. All subjects with complete data were included for analysis. AHI trajectories were constructed for early and late THN activation (Treatment[T], N=83, Month 1 and Control[C], N=45, Month 4, respectively) by computing median values. Confidence intervals were calculated by bootstrapping each median (N=30,000). Patient-reported outcome measures (PROMs) were treated similarly. Results AHI (Median (95% CI)) trajectories demonstrated a consistent pattern of pre-implant alignment (Pre-enrollment T:39.1 (36.0-45.0), C:38.0 (32.0-41.0); Baseline 1 T:36.1 (33.0-39.9), C:31.3 (27.2-38.6); Baseline 2 T:37.0 (34.3-41.0), C:35.2 (32.3-38.2)), divergence at the conclusion of the randomization period (Month 4 T:15.6 (11.9-25.3), C:30.6 (23.7-38.6)) and reconvergence following 11 months of treatment (Month 12/15 T:20.7 (16.0-26.4), C:18.1 (16.3-23.3)). Non-standardized Pre-enrollment AHI was slightly higher than Baseline values. Trajectories were similar for oxygen desaturation index (Baseline 1 T:35.3 (31.9-38.0),C:34.3 (27.5-40.3); Baseline 2 T:37.1 (33.4-39.3),C:36.8 (33.9-38.3); Month 4 T:19.5 (16.2-28.5), C:33.8 (25.4-41.1); Month 12/15 T:19.5 (16.0-25.6), C:19.7 (16.3-26.0)), the Epworth Sleepiness Scale (Baseline T:11.0 (10.0-13.0),C:11.5 (8.5-14.0); Month 4 T:6.0 (5.0-7.0), C:11.5 (8.0-12.5); Month 12/15 T:6.0 (4.0-7.0), C:5.5 (4.5-6.0)), the Functional Outcomes of Sleep Questionnaire (Baseline T:15.3 (14.0-16.5),C:14.7 (13.3-16.6); Month 4 T:18.3 (17.7-18.8), C:16.7 (14.9-17.7); Month 12/15 T:18.8 (18.3-19.3), C:18.5 (17.5-19.5)) and the Snore Outcomes Survey (Baseline T:26.6 (21.9-31.3),C:21.9 (18.8-31.3); Month 4 T:60.9 (56.3-67.9), C:29.7 (23.4-42.9); Month 12/15 T:62.5 (59.4-68.8), C:68.8 (62.5-71.9)). Conclusion Group trajectories of sleep-disordered breathing and PROMs further demonstrate the robust effects of THN in patients with moderate to severe OSA and the value of parallel-arm RCTs. Similar results may be expected in the ongoing OSPREY confirmatory trial of THN. Support (If Any) LivaNova

Introduction THN3 was the first reported parallel-arm, randomized controlled trial of hypoglossal nerve stimulation (HGNS), wherein targeted HGNS (THN) was shown to be safe and efficacious at ameliorating sleep disordered breathing in selected patients with moderate to severe OSA and BMI≤35kg/m2 without screening with drug-induced sleep endoscopy. A secondary THN3 objective was to identify baseline characteristics which enhance therapeutic response. Methods Predictors of long-term (Month 12/15) apnea-hypopnea index (AHI) response (reduction ≥50% to ≤20/hr) were identified in stages. Baseline characteristics, including polysomnography parameters, were screened one at a time using univariate logistic regression. Variables significant at α=0.25 were further selected using stepwise multivariate logistic regression. Candidate predictors were then optimized by manual, incremental threshold adjustment to maximize AHI response rate (RR). Optimized predictors were ranked according to the AHI RR and size of the corresponding subpopulation, with a goal of capturing at least 40% of the overall THN3 cohort. Results Baseline sleep efficiency (SE) in the normal range (>85%) achieved the highest AHI RR while retaining 42% (58/138) of the THN3 cohort. Similar to the overall study population, subgroup subjects were predominantly middle-aged (age 54±7 years), male (83%), Caucasian (86%) and overweight/obese (BMI 30±3 kg/m2). Short-term (Month 4) AHI RRs in the Treatment and Control groups were 59.5% and 20.0%, respectively, with long-term AHI RR at 50.9%. Median AHI was reduced from 35.1 to 16.0, as compared to 29.3 to 9.0 in the STAR trial of distal HGNS. ODI RRs (reduction ≥25%) for Treatment and Control were respectively 73.0% and 30.0% at Month 4 and 64.9% at Month12/15. Enhanced response carried through to larger point estimates for improvement in secondary variables, including the Epworth Sleepiness Scale and the Functional Outcomes of Sleep Questionnaire, exceeding minimum clinically important differences thresholds of 2-3 and 1.7-2.0, respectively. Conclusion Normal SE at Baseline was associated with enhanced AHI and ODI RR as well as patient-reported outcome measures for patients receiving THN therapy, providing results similar to those obtained with distal HGNS. Future studies, including the ongoing OSPREY trial, will be needed to prospectively validate these findings. Support (If Any) LivaNova

OBJECTIVE: To systematically review the literature for articles evaluating myofunctional therapy (MT) as treatment for obstructive sleep apnea (OSA) in children and adults and to perform a meta-analysis on the polysomnographic, snoring, and sleepiness data. DATA SOURCES: Web of Science, Scopus, MEDLINE, and The Cochrane Library. REVIEW METHODS: The searches were performed through June 18, 2014. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement was followed. RESULTS: Nine adult studies (120 patients) reported polysomnography, snoring, and/or sleepiness outcomes. The pre- and post-MT apneahypopnea indices (AHI) decreased from a mean ± standard deviation (M ± SD) of 24.5 ± 14.3/h to 12.3 ± 11.8/h, mean difference (MD) -14.26 [95% confidence interval (CI) -20.98, -7.54], P < 0.0001. Lowest oxygen saturations improved from 83.9 ± 6.0% to 86.6 ± 7.3%, MD 4.19 (95% CI 1.85, 6.54), P = 0.0005. Polysomnography snoring decreased from 14.05 ± 4.89% to 3.87 ± 4.12% of total sleep time, P < 0.001, and snoring decreased in all three studies reporting subjective outcomes. Epworth Sleepiness Scale decreased from 14.8 ± 3.5 to 8.2 ± 4.1. Two pediatric studies (25 patients) reported outcomes. In the first study of 14 children, the AHI decreased from 4.87 ± 3.0/h to 1.84 ± 3.2/h, P = 0.004. The second study evaluated children who were cured of OSA after adenotonsillectomy and palatal expansion, and found that 11 patients who continued MT remained cured (AHI 0.5 ± 0.4/h), whereas 13 controls had recurrent OSA (AHI 5.3 ± 1.5/h) after 4 y. CONCLUSION: Current literature demonstrates that myofunctional therapy decreases apnea-hypopnea index by approximately 50% in adults and 62% in children. Lowest oxygen saturations, snoring, and sleepiness outcomes improve in adults. Myofunctional therapy could serve as an adjunct to other obstructive sleep apnea treatments.

BACKGROUND The relationship between nasal surgery and its effect on continuous positive airway pressure (CPAP) device therapeutic treatment pressures and CPAP device use has not been previously systematically examined. STUDY OBJECTIVES To conduct a systematic review and meta-analysis evaluating the effect of isolated nasal surgery on therapeutic CPAP device pressures and use in adults with obstructive sleep apnea (OSA). METHODS MEDLINE, Scopus, Web of Science, and The Cochrane Library were searched through July 15, 2014. The MOOSE consensus statement and PRISMA statement were followed. RESULTS Eighteen studies (279 patients) reported CPAP data after isolated nasal surgery. Seven studies (82 patients) reported preoperative and postoperative mean therapeutic CPAP device pressures and standard deviations (SD), which reduced from 11.6 ± 2.2 to 9.5 ± 2.0 centimeters of water pressure (cwp) after nasal surgery. Pooled random effects analysis demonstrated a statistically significant pressure reduction, with a mean difference (MD) of -2.66 cwp (95% confidence interval (CI), -3.65 to -1.67); P < 0.00001. Eleven studies (153 patients) reported subjective, self-reported data for CPAP use; and a subgroup analysis demonstrated that 89.1% (57 of 64 patients) who were not using CPAP prior to nasal surgery subsequently accepted, adhered to, or tolerated it after nasal surgery. Objective, device meter-based hours of use increased in 33 patients from 3.0 ± 3.1 to 5.5 ± 2.0 h in the short term (