Temperature-controlled radiofrequency tissue volume reduction of the soft palate (somnoplasty) in the treatment of habitual snoring: results of a European multicenter trial.

Temperature-controlled radiofrequency tissue volume reduction of the soft palate has been introduced as a minimally invasive, outpatient procedure for the treatment of habitual snoring and mild obstructive sleep apnea. A prospective, non-randomized multi-center European clinical study was conducted to investigate the efficacy of Somnoplasty in reducing snoring. Each patient underwent a pre- and post-treatment full-night polysomnography. TCRFe of the soft palate (1 midline lesion/session) was carried out under local anesthesia with a maximum of 3 consecutive treatment sessions. Forty-five, nonapneic snorers (RDI 5.1 +/- 4.3, BMI 26.6 +/- 3.2 kg/m2) completed the protocol. A mean of 692.3 +/- 67.7) J was delivered/treatment session. There was a significant improvement in the snoring index 7.6 (+/- 2.1 ) vs 4.1 (+/- 2.9). p < 0.001 and in the Epworth Sleepiness Score 8.5 (+/- 5.0) versus 6.0 (+/- 4.3), p = 0.001. No major adverse events were reported and postoperative pain was minimal. Overall, 45% of patients had a post-treatment snoring index < 3 (success) and 84% of the patients reported an improvement in snoring. It was concluded that Somnoplasty, following a protocol with I midline lesion of maximal 700 J/lesion for 1-3 treatment sessions, improves snoring in the majority of patients. Further studies are required to investigate whether treatment efficacy can be improved by utilizing multiple lesions/session or by increasing the amount of energy/lesion. The absence of serious adverse events and the findings of minimal postoperative pain support the use of TCRFe (Somnoplasty) as a minimally invasive surgical procedure for snoring.