Radiofrequency volumetric tissue reduction of the soft palate: a new treatment for snoring.
OBJECTIVE
Current options for the treatment of snoring have limited 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, pain, snoring, and degree of sleepiness were evaluated. These effects were evaluated by post-treatment questionnaires.


METHODS
Prospective nonrandomized study. All included subjects snored at a level considered bothersome to their bed partner. A total of 43 patients were enrolled at the University of Maryland (UM) and the Georgia Ear Institute (GEI). Polysomnography was performed before treatment to eliminate patients with significant sleep apnea who had respiratory disturbance indices (RDIs) greater than 15 or nadir desaturations less than 80%. The mean pretreatment RDI for all patients who entered the protocol at UM was 6.7 +/- 4.7. Nine patients completed the study in this group in all other aspects, but did not return for their scheduled post-treatment polysomnogram. At GEI, pretreatment polysomnograms revealed 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 polysomnogram. Radiofrequency energy was delivered to the soft palate either in the midline (19 patients) at a mean of 698 +/- 52 J per treatment at UM or 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, with a range from 29 to 59 years. Eighty-four percent of the patients were men. The mean body mass index (BMI) was 28.5 +/- 3.2. Twenty-four patients were enrolled at GEI. The mean age was 44.0 +/- 10.9 years, with a range from 23 to 63 years. Seventy-four percent of patients were men. The mean BMI 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) obtained at the same intervals.


RESULTS
Snoring was improved in 77% of patients after three treatments or less. Seventy-nine percent of patients treated with the midline technique at UM and 96% of patients treated with the midline and left and right lateral palate technique at GEI achieved an improvement in their snoring to a level that was no longer bothersome to their bed partner. No persistent negative impact was noted concerning speech or swallowing. Improvements in degree of sleepiness were observed by comparing pretreatment 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, from 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 demonstrates the efficacy, safety, and lack of pain encountered when using radiofrequency energy delivered to the palate for the treatment of snoring. The tolerability, lack of pain, and ability to perform the procedure with the patient under local anesthesia in the office make the use of this technology an excellent option for the treatment of snoring.
Emery
B E
BE
Division of Otolaryngology--Head and Neck Surgery, University of Maryland Medical System, Baltimore 21201, USA.
Flexon
P B
PB
D000328:Adult; D000368:Aged; D003936:Diagnosis, Computer-Assisted; D006970:Disorders of Excessive Somnolence / Q000175:diagnosis / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010160:Palate, Soft / Q000033:anatomy & histology*; D017286:Polysomnography; D011446:Prospective Studies; D012720:Severity of Illness Index; D020181:Sleep Apnea, Obstructive / Q000150:complications / Q000175:diagnosis; D012913:Snoring / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome