Effectiveness of Multilevel (Tongue and Palate) Radiofrequency Tissue Ablation for Patients with Obstructive Sleep Apnea Syndrome

Abstract

The primary objective is to determine the effectiveness of multilevel (tongue base and palate) temperature controlled radiofrequency tissue ablation (TCRFTA) for patients with obstructive sleep apnea syndrome (OSAS). The secondary objective is to compare multilevel TCRFTA to nasal continuous positive airway pressure (CPAP). The study is a controlled case series of one investigator's experience with multilevel TCRFTA for patients with OSAS. Twenty-two subjects with mild to severe OSAS, without tonsil hypertrophy, completed multilevel TCRFTA (mean 4.8 tongue base and 1.8 palate treatment sessions) and had both pre- and posttreatment polysomnography. Primary outcomes included change from baseline in apnea/hypopnea index (AHI), daytime somnolence, and reaction time testing measured 2 to 3 months after TCRFTA. Secondary outcomes included change in other respiratory parameters, OSAS related quality of life, and upper airway size. Comparison of 18 patients treated with TCRFTA for mild to moderate OSAS (AHI > 5 and < or = 40) is made with 11 matched patients treated with nasal CPAP for mild to moderate OSAS. Multilevel TCRFTA significantly improved AHI (P = .001), apnea index (P = .02), as well as respiratory and total arousal indices (P = .0002 and P = .01). Significant improvement with moderate or large treatment effect sizes were noted for OSAS related quality of life (P = .01) and daytime somnolence (P = .0001), with a trend toward significant improvement in reaction time testing (P = .06), with mean posttreatment normalization of all three outcome measures. Fifty-nine percent of subjects demonstrated at least a 50% reduction in AHI to less than 20. The targeted upper airway, measured in the supine position, demonstrated a trend toward significant improvement in mean cross sectional area (P = .05) and volume (P = .10). Side effects of TCRFTA were infrequent, mild, and self-limited. No significant correlation between pretreatment parameters and outcome improvement was noted. Nasal CPAP resulted in significant improvement in AHI (P = .0004) to near normal levels, with an associated improvement in OSAS related quality of life (P = .02) and a trend toward significant improvement in daytime somnolence (P = .06). Reaction time testing demonstrated no significant improvement (P = .75). No significant differences were seen for change in AHI, OSAS related quality of life, daytime somnolence, or reaction time testing between multilevel TCRFTA and CPAP. Multilevel (tongue base and palate) TCRFTA is a low-morbidity, office-based procedure performed with local anesthesia and is an effective treatment option for patients with OSAS. On average, abnormalities in daytime somnolence, quality of life, and reaction time testing demonstrated improvement from baseline and were normalized after treatment. Polysomnographic respiratory parameters also demonstrated significant improvement with multilevel TCRFTA.