Effects of Radiofrequency versus sham surgery of the soft palate on daytime sleepiness.

OBJECTIVES/HYPOTHESIS To evaluate the effect of radiofrequency surgery of the soft palate on daytime sleepiness in snoring men with mild or no sleep apnea. STUDY DESIGN Randomized controlled trial. METHODS Thirty-five men were recruited from consecutive patients referred to the Ear, Nose, and Throat Clinic due to snoring and complaints of daytime sleepiness. The inclusion criteria were an apnea-hypopnea index (AHI) of ≤ 15, male gender, and age 18 to 65 years. Patients were randomized to either radiofrequency or sham surgery of the soft palate. All but one chose and received the option of three treatments. All patients participated in a follow-up, including an overnight sleep apnea recording and questionnaires 12 months after the last treatment. The primary outcome was daytime sleepiness measured with the Epworth Sleepiness Scale (ESS) and other questionnaires. Secondary outcomes were effects on the AHI and subjective snoring. RESULTS Thirty-two of 35 patients-19 of 20 patients in the radiofrequency surgery group and 13 of 15 patients in the sham surgery group-completed the study. No differences between the two groups in relation to the ESS or AHI were found at follow-up. CONCLUSION Radiofrequency surgery of the soft palate has no effect on daytime sleepiness, snoring, or apnea frequency in snoring men with mild or no sleep apnea 1 year after surgery. LEVEL OF EVIDENCE 1b. Laryngoscope 124:2422-2426, 2014.