Radiofrequency volumetric tissue reduction of the soft palate: A new treatment for snoring

Objective/Hypothesis: Current options for the treatment of snoring have lim ited acceptance because of intolerance, expense, pain, or need for general anesthesia. A clinical trial using a new application of a previously known technology-radiofrequency energy-was investigated to determine its efficacy in the treatment of snoring. Effects of treatment on speech, swallowing, p ain, snoring, and degree of sleepiness were evaluated. These effects were e valuated by post-treatment questionnaires. Methods: Prospective nonrandomiz ed study. All included subjects snored at a level considered bothersome to their bed partner. A total of 43 patients were enrolled at the University o f Maryland (UM) and the Georgia Ear institute (GEI). Polysomnography was pe rformed before treatment to eliminate patients with significant sleep apnea who had respiratory disturbance indices (RDIs) greater than 15 or nadir de saturations less than 80%. The mean pretreatment RDI for all patients who e ntered the protocol at UM was 6.7 +/- 4.7. Nine patients completed the stud y in this group in all other aspects, but did not return for their schedule d post-treatment polysomnogram. At GEI, pretreatment polysomnograms reveale d a mean RDI of 8.9 +/- 3.8. Eleven patients at GEI completed the study in all other aspects but did not return for their scheduled post-treatment pol ysomnogram. Radiofrequency energy was delivered to the soft palate either i n the midline (19 patients) at a mean of 698 +/- 52 J per treatment at UM o r in the midline and lateral soft palate (24 patients) at a mean of 1,254 /- 191 J per treatment at GEI. At UM the mean age was 44.3 +/- 8.4 years, w ith a range from 29 to 59 years. Eighty-four percent of the patients were m en. The mean body mass index (BMI) was 28.5 +/- 3.2. Twenty-four patients w ere enrolled at GEI. The mean age was 44.0 +/- 10.9 years, with a range fro m 23 to 63 years. Seventy-four percent of patients were men. The mean BRIT was 27.7 +/- 3.8. Snoring pain, swallowing, and speech were assessed after each treatment at post-treatment day 1, 2, or 3; week 1; week 4; and week 7 . Daytime sleepiness was assessed by the Epworth Sleepiness Scores (ESS) ob tained at the same intervals. Results: Snoring was improved in 77% of patie nts after three treatments or less. Seventy-nine percent of patients treate d with the midline technique at UM and 96% of patients treated with the mid line and left and right lateral palate technique at GEI achieved an improve ment in their snoring to a level that was no longer bothersome to their bed partner. No persistent negative impact was noted concerning speech or swal lowing. improvements in degree of sleepiness were observed by comparing pre treatment and post-treatment ESS. ESS was significantly reduced (P < .005) after treatment from 10.2 +/- 6.1 to 6.1 +/- 4.7 at UM, and at the GEI, fro m 8.75 +/- 4.4 to 5.3 +/- 3.2. After a treatment, 27% of the patients at UM and 29% at GEI required analgesics. Conclusions: This clinical trial demon strates the efficacy, safety, and lack of pain encountered when using radio frequency energy delivered to the palate for the treatment of snoring. The tolerability, lack of pain, and ability to perform the procedure with the p atient under local anesthesia in the office make the use of this technology an excellent option for the treatment of snoring.