A randomized trial of temperature-controlled radiofrequency, continuous positive airway pressure, and placebo for obstructive sleep apnea syndrome B. TUCKER WOODSON, MD, DAVID L. STEWARD, MD, EDWARD M. WEAVER, MD, MPH, and SHAHROKH JAVAHERI, MD, Milwaukee, Wisconsin, Cincinnati, Ohio, and Seattle, Washington OBJECTIVE: The study goal was to determine the effectiveness of (1) multilevel temperature-con- trolled radiofrequency tissue ablation (TCRFTA) or (2) continuous positive airway pressure (CPAP) for the treatment of mild to moderate obstructive sleep apnea syndrome (OSAS). STUDY DESIGN AND METHODS: We conducted a randomized, placebo-controlled, 2-site trial, comparing TCRFTA (n  30) and CPAP (n  30) with sham-placebo (n  30) using intention-to- treat analysis. RESULTS: Compared with pretreatment baseline, TCRFTA improved reaction time, OSAS-specific quality of life (QOL), and subjective sleepiness (all P < 0.05). Compared with sham-placebo, TCRFTA im- proved QOL, airway volume, apnea index, and re- spiratory arousal index (all P < 0.05). TCRFTA side effects and complications were mild, temporary, and similar to sham-placebo. CPAP improved QOL and sleepiness compared with baseline and QOL when compared with sham-placebo (all P < 0.05). Significant differences were not seen between TCRFTA and CPAP outcomes. CONCLUSION: TCRFTA and CPAP each improve QOL for mild-moderate OSAS patients. TCRFTA im- provements may result from changes in airway vol- ume, apnea index, and respiratory arousal index. (Otolaryngol Head Neck Surg 2003;128:848-61.) S leep disordered breathing defined by an Apnea- Hypopnea Index (AHI) of 5 or more events per hour is estimated to affect 9% to 24% of middle- aged adults. 1 Obstructive sleep apnea syndrome (OSAS) includes both sleep disordered breathing and excessive daytime somnolence 2 and affects 2% to 4% of adults. 1 It is associated with cardio- vascular disease, quality of life and performance deficits, and motor vehicle accidents. 3-6 Within the OSAS population, a large proportion of the pa- tients manifest mild or moderate disease (AHI  30 events per hour). 1 First-line treatment for many OSAS patients is nasal continuous positive airway pressure (CPAP). When used adequately, CPAP improves sleepi- ness, performance, quality of life, and cardiovas- cular risk. 4,7,8 However, the effectiveness of CPAP in patients with milder OSAS remains un- clear. 9-11 Temperature-controlled radiofrequency tissue ablation (TCRFTA) applied to the tongue base and palate have been described to treat OSAS. Several case series and one large multicenter clinical trial have demonstrated improvement in polysomno- graphic parameters and in clinically important out- comes, with low morbidity and complication rates. 12-14 Studies have also demonstrated TCRFTA successfully reduces soft tissue volume of the tongue. 12 However, none of these studies included control subjects. Thus, this study was undertaken to evaluate the effects of multilevel (tongue and palate) TCRFTA on clinically impor- tant outcomes in patients with mild to moderate From the Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Department of Otolaryngology–Head and Neck Surgery, University of Cincinnati, Department of Otolaryngology–Head and Neck Surgery, University of Washington, and Sleep Disorders Laboratory, Division of Pulmonary and Critical Care Med- icine, Department of Medicine, University of Cincinnati and Veterans Affairs Medical Center. Presented at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery, San Diego, CA, September 22-25, 2002. This work was supported by Gyrus-ENT. Dr Weaver was supported in part by the Robert Wood Johnson Clinical Sponsors Program. Reprint requests: B. Tucker Woodson, MD, Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin at Froedtert West, 9200 W Wiscon- sin Ave, Milwaukee, WI 53226; e-mail, bwoodson@mcw. edu. Copyright © 2003 by the American Academy of Otolaryn- gology–Head and Neck Surgery Foundation, Inc. 0194-5998/2003/$30.00 + 0 doi:10.1016/S0194-5998(03)00461-3 848