Celon^® radiofrequency thermo-ablative palatoplasty for snoring - a pilot study

Abstract

A prospective non-randomized study was designed to investigate the effects of Celon® radio-frequency thermo-ablation (RFTA) of the soft palate in patients with snoring/mild obstructive sleep apnoea. Ten patients, fulfilling various inclusion/exclusion criteria, underwent single operator sub-mucosal RFTA palatoplasty as an office procedure. Two separate procedures six weeks apart involved each patient receiving six distinct sub-mucosal lesions on each visit. Questionnaires including visual analogue scales (VAS) were used to evaluate post-operative pain and subjective snoring (scored by patient/partner). Polysomnography (PSG) was performed pre-operation and three months following the second procedure. Using non-parametric statistical analysis, a significant reduction in VAS snoring was noted from initial levels to those scored at six and 16 weeks in nine of 10 patients (p = 0.013 and p = 0.007 respectively). (Five of these nine showed a greater than 50 per cent reduction in score). Objectively, six of 10 patients had a reduction in the apnoea-hypopnea Index between the two PSGs, (four of these six showed a greater than 50 per cent reduction) however, this was not statistically significant. Subjective assessment of the PSG snoring signal by the senior author showed eight of 10 patients had either a reduced or much reduced signal at four months. VAS pain confirmed both procedures are well tolerated with minimal analgesia requirements. Minor complaints of transient mild palatal swelling, dry throat, catarrh and referred otalgia were noted and one patient developed mucosal ulceration following both procedures that healed within three weeks. Swallowing and speech were unaffected. These results confirm similar findings using the Somnus^® Unit, although the Celon^® device provides additional advantages ncluding inherent safety in a bipolar electrode tip, auto-stop energy application and reduced procedure time.