Radiofrequency surgery of the soft palate in the treatment of mild obstructive sleep apnea is not effective as a single-stage procedure: A randomized single-blinded placebo-controlled trial.

OBJECTIVES/HYPOTHESIS: Radiofrequency (RF) surgery of the soft palate (SP) is an established treatment option for the treatment of snoring. Due to its minimally invasive character, it has received attention in the management of mild obstructive sleep apnea syndrome (OSAS). STUDY
DESIGN: The aim of this study was to assess the efficacy and the occurrence of adverse events after single-stage SP RF surgery in patients with mild OSAS in a randomized single-blinded placebo-controlled trial in an outpatient department at a tertiary care center, academic teaching hospital.
METHODS: Thirty-two patients with mild OSAS (apnea-hypopnea index [AHI] 5-15, body mass index <35) were randomized to receive a single session of RF surgery or placebo (insertion of applicator without energy delivery) with local anesthesia. The primary outcome measures were (AHI), Epworth Sleepiness Scale, and a 36-item short-form health survey quality-of-life questionnaire. The secondary measures were the soft tissue airway parameters in cephalometric radiographs, snoring scores, and rates of adverse events.
RESULTS: Neither objectively measured significances (active AHI 11.0 [5.0-9.0] to 13.0 [2.0-26.0] and placebo AHI 12.0 [5.0-8.0] to 11.0 [1.0-29.0], P = .628), nor were trends of a diminishing effect on symptoms of mild OSAS found in the treatment arms. No significant changes in the soft tissue airway parameters occurred. One patient (5.9%) in the active treatment group was cured.
CONCLUSIONS: RF surgery of SP is not recommended as a single-stage approach in mild OSAS.

RCT Entities:   Population Interventions Outcomes