RADIOFREQUENCY VOLUMETRIC TISSUE REDUCTION OF THE PALATE IN SUBJECTS WITH SLEEP-DISORDERED BREATHING

Study objectives: To evaluate pain, swallowing, speech, edematous resp onse, tissue shrinkage, sleep, snoring, and safety (energy limits and adverse effects) following radiofrequency (RF) treatment to the palate in 22 subjects with sleep-disordered breathing. Design: This investig ation is a prospective nonrandomized study Polysomnography, radiograph ic imaging, and infrared thermography, along with questionnaires and v isual analog scales, were used to evaluate the effects of RF treatment to the palate. Setting: Treatments were delivered on an outpatient ba sis at Stanford University Medical Center. Patients: Twenty-two health y patients (18 men), with a mean age of 45.3+/-9.1 years, were enrolle d. All were snorers seeking treatment and met predetermined criteria: a respiratory disturbance index less than or equal to 15, oxygen satur ation greater than or equal to 85%, and a complaint of daytime sleepin ess. Intervention: RF was delivered to the submucosa of the palate wit h a custom-fabricated electrode for a mean duration of 141+/-30 s with a mean of 3.6+/-1.2 treatments per patient. Reduction of their snorin g scores determined the end point of the study. Results: Neither speec h nor swallowing was adversely affected. Pain was of short duration (0 to 48 h) and was controlled with acetaminophen. There wvre no infecti ons. Although there was documented edema at 24 to 48 h, there were no clinical airway compromises. Polysomnographic data showed improvement in esophageal pressure measurements of the mean nadir and the 95th per centile nadir (p=0.031, p=0.001) respectively, as well as the mean sle ep efficiency index (p=0.002). Radiographic imaging showed a mean shri nkage of 5.5+/-3.7 mm (p less than or equal to 0.0001). Subjective sno ring scores fell by a mean of 17% (8.3+/-1.8 to 1.9+/-1.7, p=0.0001) a ccompanied by improved mean Epworth sleepiness scores (8.5+/-4.4 to 5. 2+/-3.3, p=0.0001). Conclusion: The results of this investigation allo wed the formulation of safety parameters for RF in this defined popula tion with mild sleep-disordered breathing. There was a documented tiss ue reduction and improvement in symptoms in all subjects. However, giv en the small sample size and short-term follow-up, these results shoul d be confirmed by further investigation.